Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome
Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome.
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
32
Recruiting sites
-
Actual enrollment
56
Study population
Hypothalamic / syndromic obesity, Obesity / overweight
Eligibility highlights
•BMI ≥30
Primary endpoint
•BMI SDS, change
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
Inclusion criteria
Exclusion criteria
Endpoints (212)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
40 endpointsChange in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks
Time frame:Week 0, Week 16
BMI SDS, change
change from baseline, improvement
Posted result
| Group | Mean · SDS score | 95% CI |
|---|---|---|
| Part A: Liraglutide | -0.18 | - |
| Part A: Placebo | -0.18 | - |
| Part B: Liraglutide | -0.50 | - |
| Part B: Placebo | -0.48 | - |
| Part A+B: Liraglutide | -0.33 | - |
| Part A+B: Placebo | -0.29 | - |
Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 Weeks
Time frame:Week 0, Week 52
BMI SDS, change
change from baseline, improvement
Posted result
| Group | Mean · SDS score | 95% CI |
|---|---|---|
| Part A: Liraglutide | -0.27 | - |
| Part A: Placebo | -0.13 | - |
| Part B: Liraglutide | -0.79 | - |
| Part B: Placebo | -0.71 | - |
| Part A+B: Liraglutide | -0.50 | - |
| Part A+B: Placebo | -0.36 | - |
Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks
Time frame:Week 0, Week 16
BMI SDS, change
change from baseline, improvement
Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 Weeks
Time frame:Week 0, Week 52
BMI SDS, change
change from baseline, improvement
Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16
Time frame:At week 16
threshold achievement, improvement
Posted result
| Group | Number · Percentage of participants | 95% CI |
|---|---|---|
| Part A: LiraglutideYes | 27.8 | - |
| No | 72.2 | - |
| Part A: PlaceboYes | 8.3 | - |
| No | 91.7 | - |
| Part B: LiraglutideYes | 37.5 | - |
| No | 62.5 | - |
| Part B: PlaceboYes | 57.1 | - |
| No | 42.9 | - |
| Part A+B: LiraglutideYes | 32.4 | - |
| No | 67.6 | - |
| Part A+B: PlaceboYes | 26.3 | - |
| No | 73.7 | - |
Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52
Time frame:At week 52
threshold achievement, improvement
Posted result
| Group | Number · Percentage of participants | 95% CI |
|---|---|---|
| Part A: LiraglutideYes | 29.4 | - |
| No | 70.6 | - |
| Part A: PlaceboYes | 18.2 | - |
| No | 81.8 | - |
| Part B: LiraglutideYes | 35.7 | - |
| No | 64.3 | - |
| Part B: PlaceboYes | 42.9 | - |
| No | 57.1 | - |
| Part A+B: LiraglutideYes | 32.3 | - |
| No | 67.7 | - |
| Part A+B: PlaceboYes | 27.8 | - |
| No | 72.2 | - |
Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16
Time frame:At week 16
threshold achievement, improvement
Posted result
| Group | Number · Percentage of participants | 95% CI |
|---|---|---|
| Part A: LiraglutideYes | 0 | - |
| No | 100 | - |
| Part A: PlaceboYes | 0 | - |
| No | 100 | - |
| Part B: LiraglutideYes | 6.3 | - |
| No | 93.8 | - |
| Part B: PlaceboYes | 14.3 | - |
| No | 85.7 | - |
| Part A+B: LiraglutideYes | 2.9 | - |
| No | 97.1 | - |
| Part A+B: PlaceboYes | 5.3 | - |
| No | 94.7 | - |
Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52
Time frame:At week 52
threshold achievement, improvement
Posted result
| Group | Number · Percentage of participants | 95% CI |
|---|---|---|
| Part A: LiraglutideYes | 11.8 | - |
| No | 88.2 | - |
| Part A: PlaceboYes | 0 | - |
| No | 100 | - |
| Part B: LiraglutideYes | 14.3 | - |
| No | 85.7 | - |
| Part B: PlaceboYes | 28.6 | - |
| No | 71.4 | - |
| Part A+B: LiraglutideYes | 12.9 | - |
| No | 87.1 | - |
| Part A+B: PlaceboYes | 11.1 | - |
| No | 88.9 | - |
Percentage of Participants With no Increase in BMI SDS at Week 16
Time frame:At week 16
threshold achievement, improvement
Posted result
| Group | Number · Percentage of participants | 95% CI |
|---|---|---|
| Part A: LiraglutideYes | 66.7 | - |
| No | 33.3 | - |
| Part A: PlaceboYes | 75.0 | - |
| No | 25.0 | - |
| Part B: LiraglutideYes | 87.5 | - |
| No | 12.5 | - |
| Part B: PlaceboYes | 100 | - |
| No | 0 | - |
| Part A+B: LiraglutideYes | 76.5 | - |
| No | 23.5 | - |
| Part A+B: PlaceboYes | 84.2 | - |
| No | 15.8 | - |
Percentage of Participants With no Increase in BMI SDS at Week 52
Time frame:At week 52
BMI SDS, change
threshold achievement, improvement
Posted result
| Group | Number · Percentage of participants | 95% CI |
|---|---|---|
| Part A: LiraglutideYes | 70.6 | - |
| No | 29.4 | - |
| Part A: PlaceboYes | 72.7 | - |
| No | 27.3 | - |
| Part B: LiraglutideYes | 78.6 | - |
| No | 21.4 | - |
| Part B: PlaceboYes | 100 | - |
| No | 0 | - |
| Part A+B: LiraglutideYes | 73.3 | - |
| No | 26.7 | - |
| Part A+B: PlaceboYes | 81.3 | - |
| No | 18.8 | - |
Change in BMI From Baseline at Week 16
Time frame:Week 0, week 16
BMI, change
change from baseline, improvement
Posted result
| Group | Mean · kilogram per meter square (kg/m^2) | 95% CI |
|---|---|---|
| Part A: Liraglutide | -0.9 | - |
| Part A: Placebo | -0.8 | - |
| Part B: Liraglutide | -1.1 | - |
| Part B: Placebo | -1.5 | - |
| Part A+B: Liraglutide | -1.0 | - |
| Part A+B: Placebo | -1.1 | - |
Change in BMI From Baseline at Week 52
Time frame:Week 0, week 52
BMI, change
change from baseline, improvement
Posted result
| Group | Mean · kg/m^2 | 95% CI |
|---|---|---|
| Part A: Liraglutide | 0.8 | - |
| Part A: Placebo | -0.1 | - |
| Part B: Liraglutide | -0.6 | - |
| Part B: Placebo | -0.7 | - |
| Part A+B: Liraglutide | -0.7 | - |
| Part A+B: Placebo | -0.4 | - |
Change in Body Weight (Kilogram (kg)) From Baseline at Week 16
Time frame:Week 0, week 16
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Mean · (kilogram (kg)) | 95% CI |
|---|---|---|
| Part A: Liraglutide | -1.7 | - |
| Part A: Placebo | -1.1 | - |
| Part B: Liraglutide | -0.6 | - |
| Part B: Placebo | -1.0 | - |
| Part A+B: Liraglutide | -1.2 | - |
| Part A+B: Placebo | -1.0 | - |
Change in Body Weight (kg) From Baseline at Week 52
Time frame:Week 0, week 52
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Mean · kilogram | 95% CI |
|---|---|---|
| Part A: Liraglutide | -0.4 | - |
| Part A: Placebo | 1.9 | - |
| Part B: Liraglutide | 3.0 | - |
| Part B: Placebo | 2.8 | - |
| Part A+B: Liraglutide | 1.1 | - |
| Part A+B: Placebo | 2.3 | - |
Change in Body Weight (Pounds (lb)) From Baseline at Week 16
Time frame:Week 0, week 16
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Mean · pounds (lb) | 95% CI |
|---|---|---|
| Part A: Liraglutide | -3.7 | - |
| Part A: Placebo | -2.4 | - |
| Part B: Liraglutide | -1.4 | - |
| Part B: Placebo | -2.1 | - |
| Part A+B: Liraglutide | -2.6 | - |
| Part A+B: Placebo | -2.3 | - |
Change in Body Weight (lb) From Baseline at Week 52
Time frame:Week 0, week 52
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Mean · pounds | 95% CI |
|---|---|---|
| Part A: Liraglutide | -0.9 | - |
| Part A: Placebo | 4.3 | - |
| Part B: Liraglutide | 6.7 | - |
| Part B: Placebo | 6.2 | - |
| Part A+B: Liraglutide | 2.5 | - |
| Part A+B: Placebo | 5.0 | - |
Change in Body Weight (Percentage [%]) From Baseline at Week 16
Time frame:Week 0, week 16
Body weight, % change
percent change from baseline, improvement
Posted result
| Group | Mean · Percent change in body weight | 95% CI |
|---|---|---|
| Part A: Liraglutide | -1.7 | - |
| Part A: Placebo | -0.7 | - |
| Part B: Liraglutide | -1.1 | - |
| Part B: Placebo | -2.2 | - |
| Part A+B: Liraglutide | -1.4 | - |
| Part A+B: Placebo | -1.2 | - |
Change in Body Weight (%) From Baseline at Week 52
Time frame:Week 0, week 52
Body weight, % change
percent change from baseline, improvement
Posted result
| Group | Mean · Percent change in body weight | 95% CI |
|---|---|---|
| Part A: Liraglutide | -0.4 | - |
| Part A: Placebo | 2.3 | - |
| Part B: Liraglutide | 6.3 | - |
| Part B: Placebo | 4.9 | - |
| Part A+B: Liraglutide | 2.6 | - |
| Part A+B: Placebo | 3.3 | - |
Change in Waist Circumference From Baseline at Week 16
Time frame:Week 0, week 16
Waist circumference, change
change from baseline, improvement
Posted result
| Group | Mean · centimeters (cm) | 95% CI |
|---|---|---|
| Part A: Liraglutide | -2.50 | - |
| Part A: Placebo | -2.44 | - |
| Part B: Liraglutide | -0.73 | - |
| Part B: Placebo | -1.04 | - |
| Part A+B: Liraglutide | -1.70 | - |
| Part A+B: Placebo | -1.92 | - |
Change in Waist Circumference From Baseline at Week 52
Time frame:Week 0, week 52
Waist circumference, change
change from baseline, improvement
Posted result
| Group | Mean · centimeter | 95% CI |
|---|---|---|
| Part A: Liraglutide | -2.98 | - |
| Part A: Placebo | -3.48 | - |
| Part B: Liraglutide | 0.45 | - |
| Part B: Placebo | 0.97 | - |
| Part A+B: Liraglutide | -1.49 | - |
| Part A+B: Placebo | -2.09 | - |
Change in Waist-to-hip Circumference Ratio From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, improvement
Posted result
| Group | Mean · Waist-to-hip circumference ratio | 95% CI |
|---|---|---|
| Part A: Liraglutide | -0.01 | - |
| Part A: Placebo | -0.02 | - |
| Part B: Liraglutide | 0.00 | - |
| Part B: Placebo | 0.01 | - |
| Part A+B: Liraglutide | -0.01 | - |
| Part A+B: Placebo | -0.01 | - |
Change in Waist-to-hip Circumference Ratio From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, improvement
Posted result
| Group | Mean · waist-to-hip circumference ratio | 95% CI |
|---|---|---|
| Part A: Liraglutide | -0.01 | - |
| Part A: Placebo | -0.04 | - |
| Part B: Liraglutide | -0.02 | - |
| Part B: Placebo | -0.01 | - |
| Part A+B: Liraglutide | -0.02 | - |
| Part A+B: Placebo | -0.03 | - |
Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16
Time frame:At week 16
threshold achievement, improvement
Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52
Time frame:At week 52
threshold achievement, improvement
Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16
Time frame:At week 16
threshold achievement, improvement
Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52
Time frame:At week 52
threshold achievement, improvement
Percentage of Participants With no Increase in BMI SDS at Week 16
Time frame:At week 16
BMI SDS, change
threshold achievement, improvement
Percentage of Participants With no Increase in BMI SDS at Week 52
Time frame:At week 52
BMI SDS, change
threshold achievement, improvement
Change in BMI From Baseline at Week 16
Time frame:Week 0, week 16
BMI, change
change from baseline, improvement
Change in BMI From Baseline at Week 52
Time frame:Week 0, week 52
BMI, change
change from baseline, improvement
Change in Body Weight (Kilogram (kg)) From Baseline at Week 16
Time frame:Week 0, week 16
Body weight, absolute change (kg)
change from baseline, improvement
Change in Body Weight (kg) From Baseline at Week 52
Time frame:Week 0, week 52
Body weight, absolute change (kg)
change from baseline, improvement
Change in Body Weight (Pounds (lb)) From Baseline at Week 16
Time frame:Week 0, week 16
Body weight, absolute change (kg)
change from baseline, improvement
Change in Body Weight (lb) From Baseline at Week 52
Time frame:Week 0, week 52
Body weight, absolute change (kg)
change from baseline, improvement
Change in Body Weight (Percentage [%]) From Baseline at Week 16
Time frame:Week 0, week 16
Body weight, % change
percent change from baseline, improvement
Change in Body Weight (%) From Baseline at Week 52
Time frame:Week 0, week 52
Body weight, % change
percent change from baseline, improvement
Change in Waist Circumference From Baseline at Week 16
Time frame:Week 0, week 16
Waist circumference, change
change from baseline, improvement
Change in Waist Circumference From Baseline at Week 52
Time frame:Week 0, week 52
Waist circumference, change
change from baseline, improvement
Change in Waist-to-hip Circumference Ratio From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, improvement
Change in Waist-to-hip Circumference Ratio From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, improvement
Glycemic / diabetes
28 endpointsChange in Glycosylated Haemoglobin (HbA1c) From Baseline at Week 16
Time frame:Week 0, week 16
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Mean · Percentage point of HbA1c | 95% CI |
|---|---|---|
| Part A: Liraglutide | -0.2 | - |
| Part A: Placebo | 0 | - |
| Part B: Liraglutide | -0.2 | - |
| Part B: Placebo | -0.2 | - |
| Part A+B: Liraglutide | -0.2 | - |
| Part A+B: Placebo | -0.1 | - |
Change in HbA1c From Baseline at Week 52
Time frame:Week 0, week 52
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Mean · Percentage point of HbA1c | 95% CI |
|---|---|---|
| Part A: Liraglutide | -0.2 | - |
| Part A: Placebo | 0.1 | - |
| Part B: Liraglutide | -0.2 | - |
| Part B: Placebo | -0.1 | - |
| Part A+B: Liraglutide | -0.2 | - |
| Part A+B: Placebo | 0.1 | - |
Change in Fasting Plasma Glucose (FPG) From Baseline at Week 16
Time frame:Week 0, week 16
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Mean · mmol/L | 95% CI |
|---|---|---|
| Part A: Liraglutide | -0.2 | - |
| Part A: Placebo | 0.1 | - |
| Part B: Liraglutide | -0.1 | - |
| Part B: Placebo | 0.2 | - |
| Part A+B: Liraglutide | -0.2 | - |
| Part A+B: Placebo | 0.1 | - |
Change in FPG From Baseline at Week 52
Time frame:Week 0, week 52
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Mean · mmol/L | 95% CI |
|---|---|---|
| Part A: Liraglutide | 0 | - |
| Part A: Placebo | 0.3 | - |
| Part B: Liraglutide | 0 | - |
| Part B: Placebo | 0 | - |
| Part A+B: Liraglutide | 0 | - |
| Part A+B: Placebo | 0.2 | - |
Change in Fasting Insulin From Baseline at Week 16
Time frame:Week 0, week 16
ratio, improvement
Posted result
| Group | Mean · Ratio of fasting insulin | 95% CI |
|---|---|---|
| Part A: Liraglutide | 1.59 | - |
| Part A: Placebo | 0.78 | - |
| Part B: Liraglutide | 1.43 | - |
| Part B: Placebo | 1.32 | - |
| Part A+B: Liraglutide | 1.52 | - |
| Part A+B: Placebo | 0.97 | - |
Change in Fasting Insulin From Baseline at Week 52
Time frame:Week 0, week 52
ratio, improvement
Posted result
| Group | Mean · Ratio of fasting insulin | 95% CI |
|---|---|---|
| Part A: Liraglutide | 2.03 | - |
| Part A: Placebo | 0.79 | - |
| Part B: Liraglutide | 1.45 | - |
| Part B: Placebo | 1.22 | - |
| Part A+B: Liraglutide | 1.78 | - |
| Part A+B: Placebo | 0.96 | - |
Change in Fasting C Peptide From Baseline at Week 16
Time frame:Week 0, week 16
C-peptide AUC
ratio, improvement
Posted result
| Group | Mean · Ratio of fasting C peptide | 95% CI |
|---|---|---|
| Part A: Liraglutide | 1.14 | - |
| Part A: Placebo | 0.86 | - |
| Part B: Liraglutide | 1.11 | - |
| Part B: Placebo | 1.08 | - |
| Part A+B: Liraglutide | 1.13 | - |
| Part A+B: Placebo | 0.94 | - |
Change in Fasting C Peptide From Baseline at Week 52
Time frame:Week 0, week 52
C-peptide AUC
ratio, improvement
Posted result
| Group | Mean · Ratio of fasting C peptide | 95% CI |
|---|---|---|
| Part A: Liraglutide | 1.34 | - |
| Part A: Placebo | 0.91 | - |
| Part B: Liraglutide | 1.15 | - |
| Part B: Placebo | 1.09 | - |
| Part A+B: Liraglutide | 1.26 | - |
| Part A+B: Placebo | 0.98 | - |
Number of Participants in Glycaemic Category at Week 16
Time frame:week 16
categorical status, improvement
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Part A: LiraglutideNormoglycaemia | 16 | - |
| Pre-diabetes | 2 | - |
| Type 2 diabetes | 0 | - |
| Part A: PlaceboNormoglycaemia | 8 | - |
| Pre-diabetes | 4 | - |
| Type 2 diabetes | 0 | - |
| Part B: LiraglutideNormoglycaemia | 11 | - |
| Pre-diabetes | 2 | - |
| Type 2 diabetes | 0 | - |
| Part B: PlaceboNormoglycaemia | 5 | - |
| Pre-diabetes | 2 | - |
| Type 2 diabetes | 0 | - |
| Part A+B: LiraglutideNormoglycaemia | 27 | - |
| Pre-diabetes | 4 | - |
| Type 2 diabetes | 0 | - |
| Part A+B: PlaceboNormoglycaemia | 13 | - |
| Pre-diabetes | 6 | - |
| Type 2 diabetes | 0 | - |
Number of Participants in Glycaemic Category at Week 52
Time frame:Week 52
categorical status, improvement
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Part A: LiraglutideNormoglycaemia | 13 | - |
| Pre-diabetes | 2 | - |
| Type 2 diabetes | 1 | - |
| Part A: PlaceboNormoglycaemia | 4 | - |
| Pre-diabetes | 4 | - |
| Type 2 diabetes | 1 | - |
| Part B: LiraglutideNormoglycaemia | 10 | - |
| Pre-diabetes | 2 | - |
| Type 2 diabetes | 0 | - |
| Part B: PlaceboNormoglycaemia | 2 | - |
| Pre-diabetes | 3 | - |
| Type 2 diabetes | 0 | - |
| Part A+B: LiraglutideNormoglycaemia | 23 | - |
| Pre-diabetes | 4 | - |
| Type 2 diabetes | 1 | - |
| Part A+B: PlaceboNormoglycaemia | 6 | - |
| Pre-diabetes | 7 | - |
| Type 2 diabetes | 1 | - |
Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 16
Time frame:Week 0, week 16
ratio, improvement
Posted result
| Group | Mean · Ratio of HOMA-B | 95% CI |
|---|---|---|
| Part A: Liraglutide | 1.69 | - |
| Part A: Placebo | 0.70 | - |
| Part B: Liraglutide | 1.55 | - |
| Part B: Placebo | 1.07 | - |
| Part A+B: Liraglutide | 1.63 | - |
| Part A+B: Placebo | 0.82 | - |
Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 52
Time frame:Week 0, week 52
ratio, improvement
Posted result
| Group | Mean · Ratio of HOMA-B | 95% CI |
|---|---|---|
| Part A: Liraglutide | 2.24 | - |
| Part A: Placebo | 0.65 | - |
| Part B: Liraglutide | 1.50 | - |
| Part B: Placebo | 1.25 | - |
| Part A+B: Liraglutide | 1.91 | - |
| Part A+B: Placebo | 0.88 | - |
Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 16
Time frame:Week 0, week 16
HOMA-IR (insulin sensitivity)
ratio, improvement
Posted result
| Group | Mean · Ratio of HOMA-IR | 95% CI |
|---|---|---|
| Part A: Liraglutide | 1.57 | - |
| Part A: Placebo | 0.80 | - |
| Part B: Liraglutide | 1.43 | - |
| Part B: Placebo | 1.33 | - |
| Part A+B: Liraglutide | 1.51 | - |
| Part A+B: Placebo | 0.97 | - |
Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 52
Time frame:Week 0, week 52
HOMA-IR (insulin sensitivity)
ratio, improvement
Posted result
| Group | Mean · Ratio of HOMA-IR | 95% CI |
|---|---|---|
| Part A: Liraglutide | 2.26 | - |
| Part A: Placebo | 0.88 | - |
| Part B: Liraglutide | 1.45 | - |
| Part B: Placebo | 1.24 | - |
| Part A+B: Liraglutide | 1.90 | - |
| Part A+B: Placebo | 1.02 | - |
Change in Glycosylated Haemoglobin (HbA1c) From Baseline at Week 16
Time frame:Week 0, week 16
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in HbA1c From Baseline at Week 52
Time frame:Week 0, week 52
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in Fasting Plasma Glucose (FPG) From Baseline at Week 16
Time frame:Week 0, week 16
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change in FPG From Baseline at Week 52
Time frame:Week 0, week 52
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change in Fasting Insulin From Baseline at Week 16
Time frame:Week 0, week 16
ratio, improvement
Change in Fasting Insulin From Baseline at Week 52
Time frame:Week 0, week 52
ratio, improvement
Change in Fasting C Peptide From Baseline at Week 16
Time frame:Week 0, week 16
ratio, improvement
Change in Fasting C Peptide From Baseline at Week 52
Time frame:Week 0, week 52
C-peptide AUC
ratio, improvement
Number of Participants in Glycaemic Category at Week 16
Time frame:week 16
categorical status, improvement
Number of Participants in Glycaemic Category at Week 52
Time frame:Week 52
categorical status, improvement
Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 16
Time frame:Week 0, week 16
ratio, improvement
Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 52
Time frame:Week 0, week 52
ratio, improvement
Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 16
Time frame:Week 0, week 16
HOMA-IR (insulin sensitivity)
ratio, improvement
Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 52
Time frame:Week 0, week 52
HOMA-IR (insulin sensitivity)
ratio, improvement
Renal / kidney
2 endpointsChange in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, descriptive
componentsserum creatinine change, total bilirubin change
Posted result
| Group | Mean · umol/L | 95% CI |
|---|---|---|
| Part A: LiraglutideCreatinine: Change from week 0 to week 52 | 3 | - |
| Bilirubin (total): Change from week 0 to week 52 | 0 | - |
| Part A: PlaceboCreatinine: Change from week 0 to week 52 | -4 | - |
| Bilirubin (total): Change from week 0 to week 52 | 2 | - |
| Part B: LiraglutideCreatinine: Change from week 0 to week 52 | 3 | - |
| Bilirubin (total): Change from week 0 to week 52 | 0 | - |
| Part B: PlaceboCreatinine: Change from week 0 to week 52 | 5 | - |
| Bilirubin (total): Change from week 0 to week 52 | 2 | - |
| Part A+B: LiraglutideCreatinine: Change from week 0 to week 52 | 3 | - |
| Bilirubin (total): Change from week 0 to week 52 | 0 | - |
| Part A+B: PlaceboCreatinine: Change from week 0 to week 52 | -1 | - |
| Bilirubin (total): Change from week 0 to week 52 | 2 | - |
Change in Biochemistry: Albumin From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, descriptive
Posted result
| Group | Mean · g/dL | 95% CI |
|---|---|---|
| Part A: Liraglutide | -0.1 | - |
| Part A: Placebo | -0.1 | - |
| Part B: Liraglutide | 0 | - |
| Part B: Placebo | 0 | - |
| Part A+B: Liraglutide | 0 | - |
| Part A+B: Placebo | -0.1 | - |
Cardiometabolic biomarkers
42 endpointsChange in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 16
Time frame:Week 0, week 16
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
Posted result
| Group | Mean · Milligram per liter (mg/L) | 95% CI |
|---|---|---|
| Part A: Liraglutide | 0.79 | - |
| Part A: Placebo | -0.57 | - |
| Part B: Liraglutide | -2.79 | - |
| Part B: Placebo | 1.87 | - |
| Part A+B: Liraglutide | -0.61 | - |
| Part A+B: Placebo | 0.24 | - |
Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 52
Time frame:Week 0, week 52
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
Posted result
| Group | Mean · mg/L | 95% CI |
|---|---|---|
| Part A: Liraglutide | 0.25 | - |
| Part A: Placebo | 0.14 | - |
| Part B: Liraglutide | -2.42 | - |
| Part B: Placebo | -0.37 | - |
| Part A+B: Liraglutide | -0.89 | - |
| Part A+B: Placebo | -0.03 | - |
Change in Total Cholesterol From Baseline at Week 16
Time frame:Week 0, week 16
Total cholesterol, change
ratio, improvement
LOINC 2093-3
Posted result
| Group | Mean · Ratio of total cholesterol | 95% CI |
|---|---|---|
| Part A: Liraglutide | 0.99 | - |
| Part A: Placebo | 1.06 | - |
| Part B: Liraglutide | 1.02 | - |
| Part B: Placebo | 0.97 | - |
| Part A+B: Liraglutide | 1.00 | - |
| Part A+B: Placebo | 1.03 | - |
Change in Total Cholesterol From Baseline at Week 52
Time frame:Week 0, week 52
Total cholesterol, change
ratio, improvement
LOINC 2093-3
Posted result
| Group | Mean · Ratio of total cholesterol | 95% CI |
|---|---|---|
| Part A: Liraglutide | 1.00 | - |
| Part A: Placebo | 1.06 | - |
| Part B: Liraglutide | 1.01 | - |
| Part B: Placebo | 1.07 | - |
| Part A+B: Liraglutide | 1.01 | - |
| Part A+B: Placebo | 1.06 | - |
Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 16
Time frame:Week 0, week 16
LDL-C, change
ratio, improvement
LOINC 13457-7
Posted result
| Group | Mean · Ratio of LDL-cholesterol | 95% CI |
|---|---|---|
| Part A: Liraglutide | 1.01 | - |
| Part A: Placebo | 1.13 | - |
| Part B: Liraglutide | 1.04 | - |
| Part B: Placebo | 0.96 | - |
| Part A+B: Liraglutide | 1.02 | - |
| Part A+B: Placebo | 1.07 | - |
Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 52
Time frame:Week 0, week 52
LDL-C, change
ratio, improvement
LOINC 13457-7
Posted result
| Group | Mean · Ratio of LDL-cholesterol | 95% CI |
|---|---|---|
| Part A: Liraglutide | 1.02 | - |
| Part A: Placebo | 1.12 | - |
| Part B: Liraglutide | 0.99 | - |
| Part B: Placebo | 1.06 | - |
| Part A+B: Liraglutide | 1.01 | - |
| Part A+B: Placebo | 1.10 | - |
Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 16
Time frame:Week 0, week 16
HDL-C, change
ratio, improvement
LOINC 2085-9
Posted result
| Group | Mean · Ratio of HDL-cholesterol | 95% CI |
|---|---|---|
| Part A: Liraglutide | 0.96 | - |
| Part A: Placebo | 1.00 | - |
| Part B: Liraglutide | 1.01 | - |
| Part B: Placebo | 1.12 | - |
| Part A+B: Liraglutide | 0.98 | - |
| Part A+B: Placebo | 1.04 | - |
Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 52
Time frame:Week 0, week 52
HDL-C, change
ratio, improvement
LOINC 2085-9
Posted result
| Group | Mean · Ratio of HDL-cholesterol | 95% CI |
|---|---|---|
| Part A: Liraglutide | 0.99 | - |
| Part A: Placebo | 1.02 | - |
| Part B: Liraglutide | 1.06 | - |
| Part B: Placebo | 1.08 | - |
| Part A+B: Liraglutide | 1.02 | - |
| Part A+B: Placebo | 1.04 | - |
Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 16
Time frame:Week 0, week 16
Non-HDL cholesterol, change
ratio, improvement
Posted result
| Group | Mean · Ratio of non-HDL cholesterol | 95% CI |
|---|---|---|
| Part A: Liraglutide | 1.02 | - |
| Part A: Placebo | 1.09 | - |
| Part B: Liraglutide | 1.03 | - |
| Part B: Placebo | 0.93 | - |
| Part A+B: Liraglutide | 1.02 | - |
| Part A+B: Placebo | 1.04 | - |
Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 52
Time frame:Week 0, week 52
Non-HDL cholesterol, change
ratio, improvement
Posted result
| Group | Mean · Ratio of non-HDL cholesterol | 95% CI |
|---|---|---|
| Part A: Liraglutide | 1.02 | - |
| Part A: Placebo | 1.07 | - |
| Part B: Liraglutide | 1.00 | - |
| Part B: Placebo | 1.07 | - |
| Part A+B: Liraglutide | 1.01 | - |
| Part A+B: Placebo | 1.07 | - |
Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 16
Time frame:Week 0, week 16
VLDL, change
ratio, improvement
Posted result
| Group | Mean · Ratio of VLDL cholesterol | 95% CI |
|---|---|---|
| Part A: Liraglutide | 1.05 | - |
| Part A: Placebo | 0.98 | - |
| Part B: Liraglutide | 1.05 | - |
| Part B: Placebo | 0.80 | - |
| Part A+B: Liraglutide | 1.05 | - |
| Part A+B: Placebo | 0.93 | - |
Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 52
Time frame:Week 0, week 52
VLDL, change
ratio, improvement
Posted result
| Group | Mean · Ratio of VLDL cholesterol | 95% CI |
|---|---|---|
| Part A: Liraglutide | 1.06 | - |
| Part A: Placebo | 0.95 | - |
| Part B: Liraglutide | 1.03 | - |
| Part B: Placebo | 1.13 | - |
| Part A+B: Liraglutide | 1.04 | - |
| Part A+B: Placebo | 1.01 | - |
Change in Triglycerides From Baseline at Week 16
Time frame:Week 0, week 16
Triglycerides, change
ratio, improvement
LOINC 2571-8
Posted result
| Group | Mean · Ratio of triglycerides | 95% CI |
|---|---|---|
| Part A: Liraglutide | 1.04 | - |
| Part A: Placebo | 0.99 | - |
| Part B: Liraglutide | 1.05 | - |
| Part B: Placebo | 0.80 | - |
| Part A+B: Liraglutide | 1.05 | - |
| Part A+B: Placebo | 0.93 | - |
Change in Triglycerides From Baseline at Week 52
Time frame:Week 0, week 52
Triglycerides, change
ratio, improvement
LOINC 2571-8
Posted result
| Group | Mean · Ratio of triglycerides | 95% CI |
|---|---|---|
| Part A: Liraglutide | 1.07 | - |
| Part A: Placebo | 0.94 | - |
| Part B: Liraglutide | 1.04 | - |
| Part B: Placebo | 1.12 | - |
| Part A+B: Liraglutide | 1.06 | - |
| Part A+B: Placebo | 1.00 | - |
Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 16
Time frame:Week 0, week 16
Free fatty acids, change
ratio, improvement
Posted result
| Group | Mean · Ratio of FFA | 95% CI |
|---|---|---|
| Part A: Liraglutide | 1.52 | - |
| Part A: Placebo | 1.31 | - |
| Part B: Liraglutide | 1.04 | - |
| Part B: Placebo | 0.99 | - |
| Part A+B: Liraglutide | 1.31 | - |
| Part A+B: Placebo | 1.21 | - |
Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 52
Time frame:Week 0, week 52
Free fatty acids, change
ratio, improvement
Posted result
| Group | Mean · Ratio of FFA | 95% CI |
|---|---|---|
| Part A: Liraglutide | 1.15 | - |
| Part A: Placebo | 1.45 | - |
| Part B: Liraglutide | 0.85 | - |
| Part B: Placebo | 1.05 | - |
| Part A+B: Liraglutide | 1.01 | - |
| Part A+B: Placebo | 1.32 | - |
Change in Systolic and Diastolic Blood Pressure From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, improvement
componentsSystolic BP, change, Diastolic BP, change
Posted result
| Group | Mean · Millimeters of mercury (mmHg) | 95% CI |
|---|---|---|
| Part A: LiraglutideSBP: Change from week 0 to week 16 | -5 | - |
| DBP: Change from week 0 to week 16 | -1 | - |
| Part A: PlaceboSBP: Change from week 0 to week 16 | -2 | - |
| DBP: Change from week 0 to week 16 | 0 | - |
| Part B: LiraglutideSBP: Change from week 0 to week 16 | 2 | - |
| DBP: Change from week 0 to week 16 | 1 | - |
| Part B: PlaceboSBP: Change from week 0 to week 16 | 2 | - |
| DBP: Change from week 0 to week 16 | -1 | - |
| Part A+B: LiraglutideSBP: Change from week 0 to week 16 | -1 | - |
| DBP: Change from week 0 to week 16 | 0 | - |
| Part A+B: PlaceboSBP: Change from week 0 to week 16 | -1 | - |
| DBP: Change from week 0 to week 16 | 0 | - |
Change in Systolic and Diastolic Blood Pressure From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, improvement
componentsSystolic BP, change, Diastolic BP, change
Posted result
| Group | Mean · Millimeters of mercury (mmHg) | 95% CI |
|---|---|---|
| Part A: LiraglutideSBP: Change from week 0 to week 52 | -5 | - |
| DBP: Change from week 0 to week 52 | -3 | - |
| Part A: PlaceboSBP: Change from week 0 to week 52 | 4 | - |
| DBP: Change from week 0 to week 52 | 5 | - |
| Part B: LiraglutideSBP: Change from week 0 to week 52 | 4 | - |
| DBP: Change from week 0 to week 52 | 4 | - |
| Part B: PlaceboSBP: Change from week 0 to week 52 | 7 | - |
| DBP: Change from week 0 to week 52 | 1 | - |
| Part A+B: LiraglutideSBP: Change from week 0 to week 52 | -1 | - |
| DBP: Change from week 0 to week 52 | 0 | - |
| Part A+B: PlaceboSBP: Change from week 0 to week 52 | 5 | - |
| DBP: Change from week 0 to week 52 | 4 | - |
Change in Pulse From Baseline at Week 16
Time frame:Week 0, week 16
Heart rate, change
change from baseline, improvement
Posted result
| Group | Mean · Beats/minute | 95% CI |
|---|---|---|
| Part A: Liraglutide | 2 | - |
| Part A: Placebo | -2 | - |
| Part B: Liraglutide | 1 | - |
| Part B: Placebo | -9 | - |
| Part A+B: Liraglutide | 2 | - |
| Part A+B: Placebo | -4 | - |
Change in Pulse From Baseline at Week 52
Time frame:Week 0, week 52
Heart rate, change
change from baseline, improvement
Posted result
| Group | Mean · Beats/minute | 95% CI |
|---|---|---|
| Part A: Liraglutide | 1 | - |
| Part A: Placebo | -8 | - |
| Part B: Liraglutide | 10 | - |
| Part B: Placebo | -6 | - |
| Part A+B: Liraglutide | 5 | - |
| Part A+B: Placebo | -7 | - |
Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
Posted result
| Group | Mean · nanogram per milliliter (ng/mL) | 95% CI |
|---|---|---|
| Part A: LiraglutideIGF-1: Change from week 0 to week 16 | -56.89 | - |
| Cortisol: Change from week 0 to week 16 | -22.94 | - |
| Part A: PlaceboIGF-1: Change from week 0 to week 16 | -28.23 | - |
| Cortisol: Change from week 0 to week 16 | 6.75 | - |
| Part B: LiraglutideIGF-1: Change from week 0 to week 16 | 2.41 | - |
| Cortisol: Change from week 0 to week 16 | -8.09 | - |
| Part B: PlaceboIGF-1: Change from week 0 to week 16 | -14.23 | - |
| Cortisol: Change from week 0 to week 16 | -23.08 | - |
| Part A+B: LiraglutideIGF-1: Change from week 0 to week 16 | -30.31 | - |
| Cortisol: Change from week 0 to week 16 | -16.71 | - |
| Part A+B: PlaceboIGF-1: Change from week 0 to week 16 | -23.86 | - |
| Cortisol: Change from week 0 to week 16 | -4.85 | - |
Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 52
Time frame:Week 0, week 52
IGF-1 cortisol change
change from baseline, descriptive
Posted result
| Group | Mean · ng/mL | 95% CI |
|---|---|---|
| Part A: LiraglutideIGF-1: Change from week 0 to week 52 | -25.90 | - |
| Cortisol: Change from week 0 to week 52 | 3.60 | - |
| Part A: PlaceboIGF-1: Change from week 0 to week 52 | -103.45 | - |
| Cortisol: Change from week 0 to week 52 | 7.54 | - |
| Part B: LiraglutideIGF-1: Change from week 0 to week 52 | -1.47 | - |
| Cortisol: Change from week 0 to week 52 | -14.15 | - |
| Part B: PlaceboIGF-1: Change from week 0 to week 52 | 10.40 | - |
| Cortisol: Change from week 0 to week 52 | 21.67 | - |
| Part A+B: LiraglutideIGF-1: Change from week 0 to week 52 | -15.04 | - |
| Cortisol: Change from week 0 to week 52 | -4.01 | - |
| Part A+B: PlaceboIGF-1: Change from week 0 to week 52 | -59.66 | - |
| Cortisol: Change from week 0 to week 52 | 12.59 | - |
Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 16
Time frame:Week 0, week 16
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 52
Time frame:Week 0, week 52
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
Change in Total Cholesterol From Baseline at Week 16
Time frame:Week 0, week 16
Total cholesterol, change
ratio, improvement
LOINC 2093-3
Change in Total Cholesterol From Baseline at Week 52
Time frame:Week 0, week 52
Total cholesterol, change
ratio, improvement
LOINC 2093-3
Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 16
Time frame:Week 0, week 16
LDL-C, change
ratio, improvement
LOINC 13457-7
Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 52
Time frame:Week 0, week 52
LDL-C, change
ratio, improvement
LOINC 13457-7
Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 16
Time frame:Week 0, week 16
HDL-C, change
ratio, improvement
LOINC 2085-9
Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 52
Time frame:Week 0, week 52
HDL-C, change
ratio, improvement
LOINC 2085-9
Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 16
Time frame:Week 0, week 16
Non-HDL cholesterol, change
ratio, improvement
Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 52
Time frame:Week 0, week 52
Non-HDL cholesterol, change
ratio, improvement
Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 16
Time frame:Week 0, week 16
VLDL, change
ratio, improvement
Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 52
Time frame:Week 0, week 52
VLDL, change
ratio, improvement
Change in Triglycerides From Baseline at Week 16
Time frame:Week 0, week 16
Triglycerides, change
ratio, improvement
LOINC 2571-8
Change in Triglycerides From Baseline at Week 52
Time frame:Week 0, week 52
Triglycerides, change
ratio, improvement
LOINC 2571-8
Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 16
Time frame:Week 0, week 16
Free fatty acids, change
ratio, improvement
Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 52
Time frame:Week 0, week 52
Free fatty acids, change
ratio, improvement
Change in Systolic and Diastolic Blood Pressure From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, improvement
componentsSystolic BP, change, Diastolic BP, change
Change in Systolic and Diastolic Blood Pressure From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, improvement
componentsSystolic BP, change, Diastolic BP, change
Change in Pulse From Baseline at Week 16
Time frame:Week 0, week 16
Heart rate, change
change from baseline, improvement
Change in Pulse From Baseline at Week 52
Time frame:Week 0, week 52
Heart rate, change
change from baseline, improvement
Patient-reported / QoL
8 endpointsChange in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, improvement
Posted result
| Group | Mean · Score on a scale | 95% CI |
|---|---|---|
| Part A: LiraglutideHyperphagia behaviour score | -0.8 | - |
| Hyperphagia drive score | -0.9 | - |
| Hyperphagia severity score | -0.6 | - |
| Hyperphagia total score | -2.4 | - |
| Part A: PlaceboHyperphagia behaviour score | -1.7 | - |
| Hyperphagia drive score | -0.9 | - |
| Hyperphagia severity score | -0.3 | - |
| Hyperphagia total score | -2.9 | - |
| Part B: LiraglutideHyperphagia behaviour score | -1.2 | - |
| Hyperphagia drive score | -1.8 | - |
| Hyperphagia severity score | -0.1 | - |
| Hyperphagia total score | -3.1 | - |
| Part B: PlaceboHyperphagia behaviour score | -2.6 | - |
| Hyperphagia drive score | -2.0 | - |
| Hyperphagia severity score | 0.1 | - |
| Hyperphagia total score | -4.4 | - |
| Part A+B: LiraglutideHyperphagia behaviour score | -1.0 | - |
| Hyperphagia drive score | -1.3 | - |
| Hyperphagia severity score | -0.4 | - |
| Hyperphagia total score | -2.7 | - |
| Part A+B: PlaceboHyperphagia behaviour score | -2.0 | - |
| Hyperphagia drive score | -1.3 | - |
| Hyperphagia severity score | -0.2 | - |
| Hyperphagia total score | -3.5 | - |
Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, improvement
Posted result
| Group | Mean · Score on a scale | 95% CI |
|---|---|---|
| Part A: LiraglutideHyperphagia behaviour score | -0.9 | - |
| Hyperphagia drive score | -2.2 | - |
| Hyperphagia severity score | -1.3 | - |
| Hyperphagia total score | -4.4 | - |
| Part A: PlaceboHyperphagia behaviour score | -0.6 | - |
| Hyperphagia drive score | -0.5 | - |
| Hyperphagia severity score | -0.9 | - |
| Hyperphagia total score | -2.1 | - |
| Part B: LiraglutideHyperphagia behaviour score | -0.7 | - |
| Hyperphagia drive score | -1.1 | - |
| Hyperphagia severity score | -0.4 | - |
| Hyperphagia total score | -2.1 | - |
| Part B: PlaceboHyperphagia behaviour score | -2.6 | - |
| Hyperphagia drive score | -1.4 | - |
| Hyperphagia severity score | -1.4 | - |
| Hyperphagia total score | -5.4 | - |
| Part A+B: LiraglutideHyperphagia behaviour score | -0.8 | - |
| Hyperphagia drive score | -1.7 | - |
| Hyperphagia severity score | -0.9 | - |
| Hyperphagia total score | -3.4 | - |
| Part A+B: PlaceboHyperphagia behaviour score | -1.3 | - |
| Hyperphagia drive score | -0.8 | - |
| Hyperphagia severity score | -1.1 | - |
| Hyperphagia total score | -3.1 | - |
Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, improvement
Posted result
| Group | Mean · Score on a scale | 95% CI |
|---|---|---|
| Part A: Liraglutide | -2 | - |
| Part A: Placebo | 1 | - |
Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, improvement
Posted result
| Group | Mean · Score on a scale | 95% CI |
|---|---|---|
| Part A: Liraglutide | -2 | - |
| Part A: Placebo | 0 | - |
Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, improvement
Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, improvement
Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, improvement
Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, improvement
Safety / tolerability / PK
62 endpointsNumber of Treatment Emergent Adverse Events
Time frame:From week 0 to week 54
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Number · Events | 95% CI |
|---|---|---|
| Part A: Liraglutide | 134 | - |
| Part A: Placebo | 37 | - |
| Part B: Liraglutide | 159 | - |
| Part B: Placebo | 8 | - |
| Part A+B: Liraglutide | 293 | - |
| Part A+B: Placebo | 45 | - |
Number of Severe Treatment Emergent Episodes of Hypoglycaemia
Time frame:From week 0 to week 54
Severe hypoglycemia
event count, event
Posted result
| Group | Number · Episodes | 95% CI |
|---|---|---|
| Part A: Liraglutide | 0 | - |
| Part A: Placebo | 0 | - |
| Part B: Liraglutide | 1 | - |
| Part B: Placebo | 0 | - |
| Part A+B: Liraglutide | 1 | - |
| Part A+B: Placebo | 0 | - |
Number of Blood Glucose Confirmed Symptomatic Episodes of Hypoglycaemia
Time frame:From week 0 to week 54
Documented hypoglycemia
event count, event
Posted result
| Group | Number · Episodes | 95% CI |
|---|---|---|
| Part A: Liraglutide | 0 | - |
| Part A: Placebo | 0 | - |
| Part B: Liraglutide | 0 | - |
| Part B: Placebo | 0 | - |
| Part A+B: Liraglutide | 0 | - |
| Part A+B: Placebo | 0 | - |
Number of Participants With Occurrence of Anti-liraglutide Antibodies
Time frame:From week 0 to week 54
Immunogenicity (ADA)
threshold achievement, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Part A: LiraglutideYes | 2 | - |
| No | 14 | - |
| Part B: LiraglutideYes | 1 | - |
| No | 8 | - |
| Part A+B: LiraglutideYes | 3 | - |
| No | 22 | - |
Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16
Time frame:Week 0, Week 16
categorical status, descriptive
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Part A: LiraglutideWeek 0: Normal | 20 | - |
| Week 0: Abnormal, NCS | 0 | - |
| Week 0: Abnormal, CS | 0 | - |
| Week 16: Normal | 17 | - |
| Week 16: Abnormal, NCS | 0 | - |
| Week 16: Abnormal, CS | 0 | - |
| Part A: PlaceboWeek 0: Normal | 12 | - |
| Week 0: Abnormal, NCS | 0 | - |
| Week 0: Abnormal, CS | 0 | - |
| Week 16: Normal | 12 | - |
| Week 16: Abnormal, NCS | 0 | - |
| Week 16: Abnormal, CS | 0 | - |
| Part B: LiraglutideWeek 0: Normal | 17 | - |
| Week 0: Abnormal, NCS | 0 | - |
| Week 0: Abnormal, CS | 0 | - |
| Week 16: Normal | 13 | - |
| Week 16: Abnormal, NCS | 1 | - |
| Week 16: Abnormal, CS | 0 | - |
| Part B: PlaceboWeek 0: Normal | 6 | - |
| Week 0: Abnormal, NCS | 1 | - |
| Week 0: Abnormal, CS | 0 | - |
| Week 16: Normal | 7 | - |
| Week 16: Abnormal, NCS | 0 | - |
| Week 16: Abnormal, CS | 0 | - |
| Part A+B: LiraglutideWeek 0: Normal | 37 | - |
| Week 0: Abnormal, NCS | 0 | - |
| Week 0: Abnormal, CS | 0 | - |
| Week 16: Normal | 30 | - |
| Week 16: Abnormal, NCS | 1 | - |
| Week 16: Abnormal, CS | 0 | - |
| Part A+B: PlaceboWeek 0: Normal | 18 | - |
| Week 0: Abnormal, NCS | 1 | - |
| Week 0: Abnormal, CS | 0 | - |
| Week 16: Normal | 19 | - |
| Week 16: Abnormal, NCS | 0 | - |
| Week 16: Abnormal, CS | 0 | - |
Number of Participants With Change in ECG From Baseline at Week 52
Time frame:Week 0, Week 52
categorical status, descriptive
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Part A: LiraglutideWeek 0: Normal | 20 | - |
| Week 0: Abnormal, NCS | 0 | - |
| Week 0: Abnormal, CS | 0 | - |
| Week 52: Normal | 17 | - |
| Week 52: Abnormal, NCS | 1 | - |
| Week 52: Abnormal, CS | 0 | - |
| Part A: PlaceboWeek 0: Normal | 12 | - |
| Week 0: Abnormal, NCS | 0 | - |
| Week 0: Abnormal, CS | 0 | - |
| Week 52: Normal | 9 | - |
| Week 52: Abnormal, NCS | 1 | - |
| Week 52: Abnormal, CS | 0 | - |
| Part B: LiraglutideWeek 0: Normal | 17 | - |
| Week 0: Abnormal, NCS | 0 | - |
| Week 0: Abnormal, CS | 0 | - |
| Week 52: Normal | 13 | - |
| Week 52: Abnormal, NCS | 0 | - |
| Week 52: Abnormal, CS | 0 | - |
| Part B: PlaceboWeek 0: Normal | 6 | - |
| Week 0: Abnormal, NCS | 1 | - |
| Week 0: Abnormal, CS | 0 | - |
| Week 52: Normal | 4 | - |
| Week 52: Abnormal, NCS | 0 | - |
| Week 52: Abnormal, CS | 0 | - |
| Part A+B: LiraglutideWeek 0: Normal | 37 | - |
| Week 0: Abnormal, NCS | 0 | - |
| Week 0: Abnormal, CS | 0 | - |
| Week 52: Normal | 30 | - |
| Week 52: Abnormal, NCS | 1 | - |
| Week 52: Abnormal, CS | 0 | - |
| Part A+B: PlaceboWeek 0: Normal | 18 | - |
| Week 0: Abnormal, NCS | 1 | - |
| Week 0: Abnormal, CS | 0 | - |
| Week 52: Normal | 13 | - |
| Week 52: Abnormal, NCS | 1 | - |
| Week 52: Abnormal, CS | 0 | - |
Change in Haematology: Haemoglobin From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
Posted result
| Group | Mean · millimoles per liter (mmol/L) | 95% CI |
|---|---|---|
| Part A: Liraglutide | -0.18 | - |
| Part A: Placebo | 0.06 | - |
| Part B: Liraglutide | -0.20 | - |
| Part B: Placebo | -0.07 | - |
| Part A+B: Liraglutide | -0.19 | - |
| Part A+B: Placebo | 0.01 | - |
Change in Haematology: Haemoglobin From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, descriptive
Posted result
| Group | Mean · mmol/L | 95% CI |
|---|---|---|
| Part A: Liraglutide | -0.14 | - |
| Part A: Placebo | -0.01 | - |
| Part B: Liraglutide | -0.02 | - |
| Part B: Placebo | -0.02 | - |
| Part A+B: Liraglutide | -0.09 | - |
| Part A+B: Placebo | -0.01 | - |
Change in Haematology: Haematocrit From Baseline at Week 16
Time frame:Week 0, week 16
haematocrit
change from baseline, descriptive
LOINC 20570-8
Posted result
| Group | Mean · Percentage of haematocrit in blood | 95% CI |
|---|---|---|
| Part A: Liraglutide | -1.8 | - |
| Part A: Placebo | -0.5 | - |
| Part B: Liraglutide | 0.4 | - |
| Part B: Placebo | -0.6 | - |
| Part A+B: Liraglutide | -0.9 | - |
| Part A+B: Placebo | -0.5 | - |
Change in Haematology: Haematocrit From Baseline at Week 52
Time frame:Week 0, week 52
haematocrit
change from baseline, descriptive
Posted result
| Group | Mean · Percentage of haematocrit in blood | 95% CI |
|---|---|---|
| Part A: Liraglutide | -1.4 | - |
| Part A: Placebo | 0 | - |
| Part B: Liraglutide | -0.2 | - |
| Part B: Placebo | -0.8 | - |
| Part A+B: Liraglutide | -0.9 | - |
| Part A+B: Placebo | -0.3 | - |
Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
componentsthrombocytes, leukocytes, eosinophils, neutrophils, basophils, lymphocytes, monocytes
Posted result
| Group | Mean · 10^9 cells per liter (10^9/L) | 95% CI |
|---|---|---|
| Part A: LiraglutideThrombocytes: Change from week 0 to week 16 | 6 | - |
| Leukocytes: Change from week 0 to week 16 | -0.1 | - |
| Eosinophils: Change from week 0 to week 16 | -0.03 | - |
| Neutrophils: Change from week 0 to week 16 | 0.11 | - |
| Basophils: Change from week 0 to week 16 | -0.01 | - |
| Lymphocytes: Change from week 0 to week 16 | -0.24 | - |
| Monocytes: Change from week 0 to week 16 | 0.06 | - |
| Part A: PlaceboThrombocytes: Change from week 0 to week 16 | -21 | - |
| Leukocytes: Change from week 0 to week 16 | -0.3 | - |
| Eosinophils: Change from week 0 to week 16 | 0.04 | - |
| Neutrophils: Change from week 0 to week 16 | -0.22 | - |
| Basophils: Change from week 0 to week 16 | 0 | - |
| Lymphocytes: Change from week 0 to week 16 | -0.09 | - |
| Monocytes: Change from week 0 to week 16 | -0.04 | - |
| Part B: LiraglutideThrombocytes: Change from week 0 to week 16 | 8 | - |
| Leukocytes: Change from week 0 to week 16 | -0.8 | - |
| Eosinophils: Change from week 0 to week 16 | -0.14 | - |
| Neutrophils: Change from week 0 to week 16 | -0.28 | - |
| Basophils: Change from week 0 to week 16 | -0.01 | - |
| Lymphocytes: Change from week 0 to week 16 | -0.36 | - |
| Monocytes: Change from week 0 to week 16 | -0.05 | - |
| Part B: PlaceboThrombocytes: Change from week 0 to week 16 | 19 | - |
| Leukocytes: Change from week 0 to week 16 | -1.1 | - |
| Eosinophils: Change from week 0 to week 16 | 0.07 | - |
| Neutrophils: Change from week 0 to week 16 | -1.35 | - |
| Basophils: Change from week 0 to week 16 | -0.01 | - |
| Lymphocytes: Change from week 0 to week 16 | 0.09 | - |
| Monocytes: Change from week 0 to week 16 | 0.05 | - |
| Part A+B: LiraglutideThrombocytes: Change from week 0 to week 16 | 7 | - |
| Leukocytes: Change from week 0 to week 16 | -0.4 | - |
| Eosinophils: Change from week 0 to week 16 | -0.07 | - |
| Neutrophils: Change from week 0 to week 16 | -0.06 | - |
| Basophils: Change from week 0 to week 16 | -0.01 | - |
| Lymphocytes: Change from week 0 to week 16 | -0.29 | - |
| Monocytes: Change from week 0 to week 16 | 0.01 | - |
| Part A+B: PlaceboThrombocytes: Change from week 0 to week 16 | -8 | - |
| Leukocytes: Change from week 0 to week 16 | -0.6 | - |
| Eosinophils: Change from week 0 to week 16 | 0.05 | - |
| Neutrophils: Change from week 0 to week 16 | -0.62 | - |
| Basophils: Change from week 0 to week 16 | 0 | - |
| Lymphocytes: Change from week 0 to week 16 | -0.02 | - |
| Monocytes: Change from week 0 to week 16 | -0.01 | - |
Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, descriptive
componentsthrombocytes, leukocytes, eosinophils, neutrophils, basophils, lymphocytes, monocytes
Posted result
| Group | Mean · 10^9 cells per liter (10^9/L) | 95% CI |
|---|---|---|
| Part A: LiraglutideThrombocytes: Change from week 0 to week 52 | 18 | - |
| Leukocytes: Change from week 0 to week 52 | -0.2 | - |
| Eosinophils: Change from week 0 to week 52 | 0.01 | - |
| Neutrophils: Change from week 0 to week 52 | 0.11 | - |
| Basophils: Change from week 0 to week 52 | 0 | - |
| Lymphocytes: Change from week 0 to week 52 | -0.28 | - |
| Monocytes: Change from week 0 to week 52 | -0.04 | - |
| Part A: PlaceboThrombocytes: Change from week 0 to week 52 | -7 | - |
| Leukocytes: Change from week 0 to week 52 | -0.6 | - |
| Eosinophils: Change from week 0 to week 52 | 0.03 | - |
| Neutrophils: Change from week 0 to week 52 | -0.76 | - |
| Basophils: Change from week 0 to week 52 | 0 | - |
| Lymphocytes: Change from week 0 to week 52 | 0.19 | - |
| Monocytes: Change from week 0 to week 52 | -0.06 | - |
| Part B: LiraglutideThrombocytes: Change from week 0 to week 52 | -2 | - |
| Leukocytes: Change from week 0 to week 52 | -0.7 | - |
| Eosinophils: Change from week 0 to week 52 | -0.13 | - |
| Neutrophils: Change from week 0 to week 52 | -0.03 | - |
| Basophils: Change from week 0 to week 52 | -0.01 | - |
| Lymphocytes: Change from week 0 to week 52 | -0.47 | - |
| Monocytes: Change from week 0 to week 52 | -0.05 | - |
| Part B: PlaceboThrombocytes: Change from week 0 to week 52 | 37 | - |
| Leukocytes: Change from week 0 to week 52 | 0.3 | - |
| Eosinophils: Change from week 0 to week 52 | -0.17 | - |
| Neutrophils: Change from week 0 to week 52 | -0.07 | - |
| Basophils: Change from week 0 to week 52 | 0.02 | - |
| Lymphocytes: Change from week 0 to week 52 | 0.39 | - |
| Monocytes: Change from week 0 to week 52 | 0.14 | - |
| Part A+B: LiraglutideThrombocytes: Change from week 0 to week 52 | 10 | - |
| Leukocytes: Change from week 0 to week 52 | -0.4 | - |
| Eosinophils: Change from week 0 to week 52 | -0.05 | - |
| Neutrophils: Change from week 0 to week 52 | 0.05 | - |
| Basophils: Change from week 0 to week 52 | -0.01 | - |
| Lymphocytes: Change from week 0 to week 52 | -0.36 | - |
| Monocytes: Change from week 0 to week 52 | -0.04 | - |
| Part A+B: PlaceboThrombocytes: Change from week 0 to week 52 | 5 | - |
| Leukocytes: Change from week 0 to week 52 | -0.3 | - |
| Eosinophils: Change from week 0 to week 52 | -0.03 | - |
| Neutrophils: Change from week 0 to week 52 | -0.55 | - |
| Basophils: Change from week 0 to week 52 | 0.01 | - |
| Lymphocytes: Change from week 0 to week 52 | 0.25 | - |
| Monocytes: Change from week 0 to week 52 | 0 | - |
Change in Haematology: Erythrocytes From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
Posted result
| Group | Mean · 10^12 cells per liter (10^12/L) | 95% CI |
|---|---|---|
| Part A: Liraglutide | -0.1 | - |
| Part A: Placebo | 0 | - |
| Part B: Liraglutide | 0.1 | - |
| Part B: Placebo | 0 | - |
| Part A+B: Liraglutide | -0.1 | - |
| Part A+B: Placebo | 0 | - |
Change in Haematology: Erythrocytes From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, descriptive
Posted result
| Group | Mean · 10^12 cells per liter (10^12/L) | 95% CI |
|---|---|---|
| Part A: Liraglutide | -0.1 | - |
| Part A: Placebo | 0 | - |
| Part B: Liraglutide | -0.1 | - |
| Part B: Placebo | 0 | - |
| Part A+B: Liraglutide | -0.1 | - |
| Part A+B: Placebo | 0 | - |
Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
Posted result
| Group | Mean · micro mole per liter (umol/L) | 95% CI |
|---|---|---|
| Part A: LiraglutideCreatinine: Change from week 0 to week 16 | 1 | - |
| Bilirubin (total): Change from week 0 to week 16 | 0 | - |
| Part A: PlaceboCreatinine: Change from week 0 to week 16 | 0 | - |
| Bilirubin (total): Change from week 0 to week 16 | 0 | - |
| Part B: LiraglutideCreatinine: Change from week 0 to week 16 | 2 | - |
| Bilirubin (total): Change from week 0 to week 16 | 0 | - |
| Part B: PlaceboCreatinine: Change from week 0 to week 16 | 0 | - |
| Bilirubin (total): Change from week 0 to week 16 | 1 | - |
| Part A+B: LiraglutideCreatinine: Change from week 0 to week 16 | 1 | - |
| Bilirubin (total): Change from week 0 to week 16 | 0 | - |
| Part A+B: PlaceboCreatinine: Change from week 0 to week 16 | 0 | - |
| Bilirubin (total): Change from week 0 to week 16 | 0 | - |
Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
componentscreatine kinase change, amylase change, lipase change, ALT, change, AST, change, alp change
Posted result
| Group | Mean · Units per liter (U/L) | 95% CI |
|---|---|---|
| Part A: LiraglutideCreatinine kinase: Change from week 0 to week 16 | -3 | - |
| Amylase: Change from week 0 to week 16 | 5 | - |
| Lipase: Change from week 0 to week 16 | 10 | - |
| ALT: Change from week 0 to week 16 | -9 | - |
| AST: Change from week 0 to week 16 | -6 | - |
| ALP: Change from week 0 to week 16 | -10 | - |
| Part A: PlaceboCreatinine kinase: Change from week 0 to week 16 | 16 | - |
| Amylase: Change from week 0 to week 16 | -2 | - |
| Lipase: Change from week 0 to week 16 | 0 | - |
| ALT: Change from week 0 to week 16 | -4 | - |
| AST: Change from week 0 to week 16 | 0 | - |
| ALP: Change from week 0 to week 16 | -7 | - |
| Part B: LiraglutideCreatinine kinase: Change from week 0 to week 16 | 3 | - |
| Amylase: Change from week 0 to week 16 | 8 | - |
| Lipase: Change from week 0 to week 16 | 8 | - |
| ALT: Change from week 0 to week 16 | -2 | - |
| AST: Change from week 0 to week 16 | -2 | - |
| ALP: Change from week 0 to week 16 | -21 | - |
| Part B: PlaceboCreatinine kinase: Change from week 0 to week 16 | -5 | - |
| Amylase: Change from week 0 to week 16 | 8 | - |
| Lipase: Change from week 0 to week 16 | 1 | - |
| ALT: Change from week 0 to week 16 | -25 | - |
| AST: Change from week 0 to week 16 | -18 | - |
| ALP: Change from week 0 to week 16 | -47 | - |
| Part A+B: LiraglutideCreatinine kinase: Change from week 0 to week 16 | -1 | - |
| Amylase: Change from week 0 to week 16 | 6 | - |
| Lipase: Change from week 0 to week 16 | 9 | - |
| ALT: Change from week 0 to week 16 | -6 | - |
| AST: Change from week 0 to week 16 | -4 | - |
| ALP: Change from week 0 to week 16 | -14 | - |
| Part A+B: PlaceboCreatinine kinase: Change from week 0 to week 16 | 10 | - |
| Amylase: Change from week 0 to week 16 | 1 | - |
| Lipase: Change from week 0 to week 16 | 0 | - |
| ALT: Change from week 0 to week 16 | -10 | - |
| AST: Change from week 0 to week 16 | -6 | - |
| ALP: Change from week 0 to week 16 | -19 | - |
Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, descriptive
componentscreatine kinase change, amylase change, lipase change, ALT, change, AST, change, alp change
Posted result
| Group | Mean · Units per liter (U/L) | 95% CI |
|---|---|---|
| Part A: LiraglutideCreatinine kinase: Change from week 0 to week 52 | 30 | - |
| Amylase: Change from week 0 to week 52 | 4 | - |
| Lipase: Change from week 0 to week 52 | 9 | - |
| ALT: Change from week 0 to week 52 | 1 | - |
| AST: Change from week 0 to week 52 | -2 | - |
| ALP: Change from week 0 to week 52 | -24 | - |
| Part A: PlaceboCreatinine kinase: Change from week 0 to week 52 | -4 | - |
| Amylase: Change from week 0 to week 52 | 2 | - |
| Lipase: Change from week 0 to week 52 | -1 | - |
| ALT: Change from week 0 to week 52 | 4 | - |
| AST: Change from week 0 to week 52 | 9 | - |
| ALP: Change from week 0 to week 52 | -35 | - |
| Part B: LiraglutideCreatinine kinase: Change from week 0 to week 52 | 25 | - |
| Amylase: Change from week 0 to week 52 | 7 | - |
| Lipase: Change from week 0 to week 52 | 7 | - |
| ALT: Change from week 0 to week 52 | 0 | - |
| AST: Change from week 0 to week 52 | 1 | - |
| ALP: Change from week 0 to week 52 | -25 | - |
| Part B: PlaceboCreatinine kinase: Change from week 0 to week 52 | -8 | - |
| Amylase: Change from week 0 to week 52 | 8 | - |
| Lipase: Change from week 0 to week 52 | 3 | - |
| ALT: Change from week 0 to week 52 | -24 | - |
| AST: Change from week 0 to week 52 | -21 | - |
| ALP: Change from week 0 to week 52 | -26 | - |
| Part A+B: LiraglutideCreatinine kinase: Change from week 0 to week 52 | 28 | - |
| Amylase: Change from week 0 to week 52 | 5 | - |
| Lipase: Change from week 0 to week 52 | 8 | - |
| ALT: Change from week 0 to week 52 | 1 | - |
| AST: Change from week 0 to week 52 | -1 | - |
| ALP: Change from week 0 to week 52 | -24 | - |
| Part A+B: PlaceboCreatinine kinase: Change from week 0 to week 52 | -5 | - |
| Amylase: Change from week 0 to week 52 | 4 | - |
| Lipase: Change from week 0 to week 52 | 0 | - |
| ALT: Change from week 0 to week 52 | -6 | - |
| AST: Change from week 0 to week 52 | 0 | - |
| ALP: Change from week 0 to week 52 | -32 | - |
Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
Posted result
| Group | Mean · mmol/L | 95% CI |
|---|---|---|
| Part A: LiraglutideUrea: Change from week 0 to week 16 | 0.03 | - |
| Sodium: Change from week 0 to week 16 | 0 | - |
| Potassium: Change from week 0 to week 16 | 0.1 | - |
| Calcium: Change from week 0 to week 16 | 0 | - |
| Part A: PlaceboUrea: Change from week 0 to week 16 | -0.51 | - |
| Sodium: Change from week 0 to week 16 | 2 | - |
| Potassium: Change from week 0 to week 16 | -0.1 | - |
| Calcium: Change from week 0 to week 16 | 0 | - |
| Part B: LiraglutideUrea: Change from week 0 to week 16 | 0 | - |
| Sodium: Change from week 0 to week 16 | 1 | - |
| Potassium: Change from week 0 to week 16 | -0.2 | - |
| Calcium: Change from week 0 to week 16 | 0.08 | - |
| Part B: PlaceboUrea: Change from week 0 to week 16 | 0.09 | - |
| Sodium: Change from week 0 to week 16 | 0 | - |
| Potassium: Change from week 0 to week 16 | -0.1 | - |
| Calcium: Change from week 0 to week 16 | 0.02 | - |
| Part A+B: LiraglutideUrea: Change from week 0 to week 16 | 0.02 | - |
| Sodium: Change from week 0 to week 16 | 0 | - |
| Potassium: Change from week 0 to week 16 | 0 | - |
| Calcium: Change from week 0 to week 16 | 0.03 | - |
| Part A+B: PlaceboUrea: Change from week 0 to week 16 | -0.31 | - |
| Sodium: Change from week 0 to week 16 | 1 | - |
| Potassium: Change from week 0 to week 16 | -0.1 | - |
| Calcium: Change from week 0 to week 16 | 0.01 | - |
Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, descriptive
Posted result
| Group | Mean · mmol/L | 95% CI |
|---|---|---|
| Part A: LiraglutideUrea: Change from week 0 to week 52 | -0.38 | - |
| Sodium: Change from week 0 to week 52 | -1 | - |
| Potassium: Change from week 0 to week 52 | -0.2 | - |
| Calcium: Change from week 0 to week 52 | -0.05 | - |
| Part A: PlaceboUrea: Change from week 0 to week 52 | -0.34 | - |
| Sodium: Change from week 0 to week 52 | -2 | - |
| Potassium: Change from week 0 to week 52 | -0.1 | - |
| Calcium: Change from week 0 to week 52 | -0.11 | - |
| Part B: LiraglutideUrea: Change from week 0 to week 52 | -0.21 | - |
| Sodium: Change from week 0 to week 52 | 1 | - |
| Potassium: Change from week 0 to week 52 | -0.2 | - |
| Calcium: Change from week 0 to week 52 | 0.09 | - |
| Part B: PlaceboUrea: Change from week 0 to week 52 | -0.04 | - |
| Sodium: Change from week 0 to week 52 | 2 | - |
| Potassium: Change from week 0 to week 52 | 0 | - |
| Calcium: Change from week 0 to week 52 | 0 | - |
| Part A+B: LiraglutideUrea: Change from week 0 to week 52 | -0.31 | - |
| Sodium: Change from week 0 to week 52 | 0 | - |
| Potassium: Change from week 0 to week 52 | -0.2 | - |
| Calcium: Change from week 0 to week 52 | 0.01 | - |
| Part A+B: PlaceboUrea: Change from week 0 to week 52 | -0.24 | - |
| Sodium: Change from week 0 to week 52 | -1 | - |
| Potassium: Change from week 0 to week 52 | -0.1 | - |
| Calcium: Change from week 0 to week 52 | -0.08 | - |
Change in Biochemistry: Albumin From Baseline at Week 16
Time frame:Week 0, week 16
albumin serum
change from baseline, descriptive
LOINC 1751-7
Posted result
| Group | Mean · gram per deciliter (g/dL) | 95% CI |
|---|---|---|
| Part A: Liraglutide | 0 | - |
| Part A: Placebo | 0 | - |
| Part B: Liraglutide | 0 | - |
| Part B: Placebo | 0 | - |
| Part A+B: Liraglutide | 0 | - |
| Part A+B: Placebo | 0 | - |
Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
Posted result
| Group | Mean · nanogram per milliliter (ng/mL) | 95% CI |
|---|---|---|
| Part A: Liraglutide | -0.01 | - |
| Part A: Placebo | -0.17 | - |
| Part B: Liraglutide | 0.17 | - |
| Part B: Placebo | -0.04 | - |
| Part A+B: Liraglutide | 0.07 | - |
| Part A+B: Placebo | -0.12 | - |
Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, descriptive
Posted result
| Group | Mean · ng/mL | 95% CI |
|---|---|---|
| Part A: Liraglutide | 0.03 | - |
| Part A: Placebo | -0.14 | - |
| Part B: Liraglutide | -0.01 | - |
| Part B: Placebo | 0.17 | - |
| Part A+B: Liraglutide | 0.01 | - |
| Part A+B: Placebo | -0.01 | - |
Change in Hormone Level: Calcitonin From Baseline at Week 16
Time frame:Week 0, week 16
Thyroid event
change from baseline, descriptive
Posted result
| Group | Mean · nanogram per liter (ng/L) | 95% CI |
|---|---|---|
| Part A: Liraglutide | 0 | - |
| Part A: Placebo | 0 | - |
| Part B: Liraglutide | 0.3 | - |
| Part B: Placebo | 0 | - |
| Part A+B: Liraglutide | 0.1 | - |
| Part A+B: Placebo | 0 | - |
Change in Hormone Level: Calcitonin From Baseline at Week 52
Time frame:Week 0, week 52
Thyroid event
change from baseline, descriptive
Posted result
| Group | Mean · ng/L | 95% CI |
|---|---|---|
| Part A: Liraglutide | 0.1 | - |
| Part A: Placebo | 0 | - |
| Part B: Liraglutide | 0.5 | - |
| Part B: Placebo | 0 | - |
| Part A+B: Liraglutide | 0.3 | - |
| Part A+B: Placebo | 0 | - |
Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
Posted result
| Group | Mean · Milli-international units/liter (mIU/L) | 95% CI |
|---|---|---|
| Part A: LiraglutideTSH: Change from week 0 to week 16 | -0.34 | - |
| Prolactin: Change from week 0 to week 16 | 7 | - |
| Part A: PlaceboTSH: Change from week 0 to week 16 | -0.01 | - |
| Prolactin: Change from week 0 to week 16 | -6 | - |
| Part B: LiraglutideTSH: Change from week 0 to week 16 | -0.09 | - |
| Prolactin: Change from week 0 to week 16 | 0 | - |
| Part B: PlaceboTSH: Change from week 0 to week 16 | -0.59 | - |
| Prolactin: Change from week 0 to week 16 | -22 | - |
| Part A+B: LiraglutideTSH: Change from week 0 to week 16 | -0.23 | - |
| Prolactin: Change from week 0 to week 16 | 4 | - |
| Part A+B: PlaceboTSH: Change from week 0 to week 16 | -0.23 | - |
| Prolactin: Change from week 0 to week 16 | -12 | - |
Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, descriptive
Posted result
| Group | Mean · mIU/L | 95% CI |
|---|---|---|
| Part A: LiraglutideTSH: Change from week 0 to week 52 | 0.02 | - |
| Prolactin: Change from week 0 to week 52 | 10 | - |
| Part A: PlaceboTSH: Change from week 0 to week 52 | -0.48 | - |
| Prolactin: Change from week 0 to week 52 | 8 | - |
| Part B: LiraglutideTSH: Change from week 0 to week 52 | -0.75 | - |
| Prolactin: Change from week 0 to week 52 | -3 | - |
| Part B: PlaceboTSH: Change from week 0 to week 52 | -0.17 | - |
| Prolactin: Change from week 0 to week 52 | 29 | - |
| Part A+B: LiraglutideTSH: Change from week 0 to week 52 | -0.30 | - |
| Prolactin: Change from week 0 to week 52 | 5 | - |
| Part A+B: PlaceboTSH: Change from week 0 to week 52 | -0.38 | - |
| Prolactin: Change from week 0 to week 52 | 15 | - |
Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
Posted result
| Group | Mean · picomole per liter (pmol/L) | 95% CI |
|---|---|---|
| Part A: LiraglutideT4: Change from week 0 to week 16 | -0.6 | - |
| ACTH: Change from week 0 to week 16 | 0.99 | - |
| Part A: PlaceboT4: Change from week 0 to week 16 | 0.3 | - |
| ACTH: Change from week 0 to week 16 | -0.85 | - |
| Part B: LiraglutideT4: Change from week 0 to week 16 | 0.7 | - |
| ACTH: Change from week 0 to week 16 | -0.37 | - |
| Part B: PlaceboT4: Change from week 0 to week 16 | 0.1 | - |
| ACTH: Change from week 0 to week 16 | -1.32 | - |
| Part A+B: LiraglutideT4: Change from week 0 to week 16 | -0.1 | - |
| ACTH: Change from week 0 to week 16 | 0.42 | - |
| Part A+B: PlaceboT4: Change from week 0 to week 16 | 0.2 | - |
| ACTH: Change from week 0 to week 16 | -1.02 | - |
Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, descriptive
componentsfree thyroxine free t4 change, acth change
Posted result
| Group | Mean · pmol/L | 95% CI |
|---|---|---|
| Part A: LiraglutideT4: Change from week 0 to week 52 | -0.4 | - |
| ACTH: Change from week 0 to week 52 | -0.02 | - |
| Part A: PlaceboT4: Change from week 0 to week 52 | 1.9 | - |
| ACTH: Change from week 0 to week 52 | 1.29 | - |
| Part B: LiraglutideT4: Change from week 0 to week 52 | -0.1 | - |
| ACTH: Change from week 0 to week 52 | 0.98 | - |
| Part B: PlaceboT4: Change from week 0 to week 52 | 0.8 | - |
| ACTH: Change from week 0 to week 52 | 0.20 | - |
| Part A+B: LiraglutideT4: Change from week 0 to week 52 | -0.3 | - |
| ACTH: Change from week 0 to week 52 | 0.42 | - |
| Part A+B: PlaceboT4: Change from week 0 to week 52 | 1.5 | - |
| ACTH: Change from week 0 to week 52 | 0.89 | - |
Number of Participants With Change in Physical Examination From Baseline at Week 16
Time frame:Week 0, week 16
descriptive
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Part A: LiraglutideGeneral Appearance: Week 0 | 14 | - |
| General Appearance: Week 0 | 2 | - |
| General Appearance: Week 0 | 4 | - |
| General Appearance: Week 16 | 14 | - |
| General Appearance: Week 16 | 1 | - |
| General Appearance: Week 16 | 4 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 19 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 1 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 0 | - |
| Head, ears, eyes, nose, throat, neck: Week 16 | 18 | - |
| Head, ears, eyes, nose, throat, neck: Week 16 | 1 | - |
| Head, ears, eyes, nose, throat, neck: Week 16 | 0 | - |
| Respiratory system: Week 0 | 20 | - |
| Respiratory system: Week 0 | 0 | - |
| Respiratory system: Week 0 | 0 | - |
| Respiratory system: Week 16 | 19 | - |
| Respiratory system: Week 16 | 0 | - |
| Respiratory system: Week 16 | 0 | - |
| Cardiovascular system: Week 0 | 19 | - |
| Cardiovascular system: Week 0 | 1 | - |
| Cardiovascular system: Week 0 | 0 | - |
| Cardiovascular system: Week 16 | 18 | - |
| Cardiovascular system: Week 16 | 1 | - |
| Cardiovascular system: Week 16 | 0 | - |
| GI system including mouth: Week 0 | 19 | - |
| GI system including mouth: Week 0 | 1 | - |
| GI system including mouth: Week 0 | 0 | - |
| GI system including mouth: Week 16 | 17 | - |
| GI system including mouth: Week 16 | 2 | - |
| GI system including mouth: Week 16 | 0 | - |
| Musculoskeletal system: Week 0 | 15 | - |
| Musculoskeletal system: Week 0 | 3 | - |
| Musculoskeletal system: Week 0 | 2 | - |
| Musculoskeletal system: Week 16 | 16 | - |
| Musculoskeletal system: Week 16 | 2 | - |
| Musculoskeletal system: Week 16 | 1 | - |
| CNS and PNS: Week 0 | 16 | - |
| CNS and PNS: Week 0 | 2 | - |
| CNS and PNS: Week 0 | 2 | - |
| CNS and PNS: Week 16 | 15 | - |
| CNS and PNS: Week 16 | 2 | - |
| CNS and PNS: Week 16 | 2 | - |
| Skin: Week 0 | 11 | - |
| Skin: Week 0 | 6 | - |
| Skin: Week 0 | 3 | - |
| Skin: Week 16 | 12 | - |
| Skin: Week 16 | 5 | - |
| Skin: Week 16 | 2 | - |
| Thyroid gland: Week 0 | 20 | - |
| Thyroid gland: Week 0 | 0 | - |
| Thyroid gland: Week 0 | 0 | - |
| Thyroid gland: Week 16 | 19 | - |
| Thyroid gland: Week 16 | 0 | - |
| Thyroid gland: Week 16 | 0 | - |
| Lymph node palpation: Week 0 | 19 | - |
| Lymph node palpation: Week 0 | 1 | - |
| Lymph node palpation: Week 0 | 0 | - |
| Lymph node palpation: Week 16 | 19 | - |
| Lymph node palpation: Week 16 | 0 | - |
| Lymph node palpation: Week 16 | 0 | - |
| Part A: PlaceboGeneral Appearance: Week 0 | 10 | - |
| General Appearance: Week 0 | 1 | - |
| General Appearance: Week 0 | 1 | - |
| General Appearance: Week 16 | 11 | - |
| General Appearance: Week 16 | 0 | - |
| General Appearance: Week 16 | 1 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 10 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 2 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 0 | - |
| Head, ears, eyes, nose, throat, neck: Week 16 | 12 | - |
| Head, ears, eyes, nose, throat, neck: Week 16 | 0 | - |
| Head, ears, eyes, nose, throat, neck: Week 16 | 0 | - |
| Respiratory system: Week 0 | 12 | - |
| Respiratory system: Week 0 | 0 | - |
| Respiratory system: Week 0 | 0 | - |
| Respiratory system: Week 16 | 12 | - |
| Respiratory system: Week 16 | 0 | - |
| Respiratory system: Week 16 | 0 | - |
| Cardiovascular system: Week 0 | 12 | - |
| Cardiovascular system: Week 0 | 0 | - |
| Cardiovascular system: Week 0 | 0 | - |
| Cardiovascular system: Week 16 | 12 | - |
| Cardiovascular system: Week 16 | 0 | - |
| Cardiovascular system: Week 16 | 0 | - |
| GI system including mouth: Week 0 | 12 | - |
| GI system including mouth: Week 0 | 0 | - |
| GI system including mouth: Week 0 | 0 | - |
| GI system including mouth: Week 16 | 12 | - |
| GI system including mouth: Week 16 | 0 | - |
| GI system including mouth: Week 16 | 0 | - |
| Musculoskeletal system: Week 0 | 9 | - |
| Musculoskeletal system: Week 0 | 2 | - |
| Musculoskeletal system: Week 0 | 1 | - |
| Musculoskeletal system: Week 16 | 9 | - |
| Musculoskeletal system: Week 16 | 1 | - |
| Musculoskeletal system: Week 16 | 2 | - |
| CNS and PNS: Week 0 | 10 | - |
| CNS and PNS: Week 0 | 0 | - |
| CNS and PNS: Week 0 | 2 | - |
| CNS and PNS: Week 16 | 11 | - |
| CNS and PNS: Week 16 | 0 | - |
| CNS and PNS: Week 16 | 1 | - |
| Skin: Week 0 | 7 | - |
| Skin: Week 0 | 4 | - |
| Skin: Week 0 | 1 | - |
| Skin: Week 16 | 8 | - |
| Skin: Week 16 | 3 | - |
| Skin: Week 16 | 1 | - |
| Thyroid gland: Week 0 | 12 | - |
| Thyroid gland: Week 0 | 0 | - |
| Thyroid gland: Week 0 | 0 | - |
| Thyroid gland: Week 16 | 12 | - |
| Thyroid gland: Week 16 | 0 | - |
| Thyroid gland: Week 16 | 0 | - |
| Lymph node palpation: Week 0 | 12 | - |
| Lymph node palpation: Week 0 | 0 | - |
| Lymph node palpation: Week 0 | 0 | - |
| Lymph node palpation: Week 16 | 12 | - |
| Lymph node palpation: Week 16 | 0 | - |
| Lymph node palpation: Week 16 | 0 | - |
| Part B: LiraglutideGeneral Appearance: Week 0 | 12 | - |
| General Appearance: Week 0 | 3 | - |
| General Appearance: Week 0 | 2 | - |
| General Appearance: Week 16 | 11 | - |
| General Appearance: Week 16 | 4 | - |
| General Appearance: Week 16 | 0 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 15 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 2 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 0 | - |
| Head, ears, eyes, nose, throat, neck: Week 16 | 15 | - |
| Head, ears, eyes, nose, throat, neck: Week 16 | 0 | - |
| Head, ears, eyes, nose, throat, neck: Week 16 | 0 | - |
| Respiratory system: Week 0 | 16 | - |
| Respiratory system: Week 0 | 1 | - |
| Respiratory system: Week 0 | 0 | - |
| Respiratory system: Week 16 | 15 | - |
| Respiratory system: Week 16 | 0 | - |
| Respiratory system: Week 16 | 0 | - |
| Cardiovascular system: Week 0 | 17 | - |
| Cardiovascular system: Week 0 | 0 | - |
| Cardiovascular system: Week 0 | 0 | - |
| Cardiovascular system: Week 16 | 15 | - |
| Cardiovascular system: Week 16 | 0 | - |
| Cardiovascular system: Week 16 | 0 | - |
| GI system including mouth: Week 0 | 17 | - |
| GI system including mouth: Week 0 | 0 | - |
| GI system including mouth: Week 0 | 0 | - |
| GI system including mouth: Week 16 | 15 | - |
| GI system including mouth: Week 16 | 0 | - |
| GI system including mouth: Week 16 | 0 | - |
| Musculoskeletal system: Week 0 | 14 | - |
| Musculoskeletal system: Week 0 | 3 | - |
| Musculoskeletal system: Week 0 | 0 | - |
| Musculoskeletal system: Week 16 | 11 | - |
| Musculoskeletal system: Week 16 | 4 | - |
| Musculoskeletal system: Week 16 | 0 | - |
| CNS and PNS: Week 0 | 15 | - |
| CNS and PNS: Week 0 | 1 | - |
| CNS and PNS: Week 0 | 1 | - |
| CNS and PNS: Week 16 | 14 | - |
| CNS and PNS: Week 16 | 1 | - |
| CNS and PNS: Week 16 | 0 | - |
| Skin: Week 0 | 10 | - |
| Skin: Week 0 | 6 | - |
| Skin: Week 0 | 1 | - |
| Skin: Week 16 | 10 | - |
| Skin: Week 16 | 5 | - |
| Skin: Week 16 | 0 | - |
| Thyroid gland: Week 0 | 17 | - |
| Thyroid gland: Week 0 | 0 | - |
| Thyroid gland: Week 0 | 0 | - |
| Thyroid gland: Week 16 | 15 | - |
| Thyroid gland: Week 16 | 0 | - |
| Thyroid gland: Week 16 | 0 | - |
| Lymph node palpation: Week 0 | 17 | - |
| Lymph node palpation: Week 0 | 0 | - |
| Lymph node palpation: Week 0 | 0 | - |
| Lymph node palpation: Week 16 | 15 | - |
| Lymph node palpation: Week 16 | 0 | - |
| Lymph node palpation: Week 16 | 0 | - |
| Part B: PlaceboGeneral Appearance: Week 0 | 5 | - |
| General Appearance: Week 0 | 1 | - |
| General Appearance: Week 0 | 1 | - |
| General Appearance: Week 16 | 5 | - |
| General Appearance: Week 16 | 1 | - |
| General Appearance: Week 16 | 1 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 6 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 1 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 0 | - |
| Head, ears, eyes, nose, throat, neck: Week 16 | 7 | - |
| Head, ears, eyes, nose, throat, neck: Week 16 | 0 | - |
| Head, ears, eyes, nose, throat, neck: Week 16 | 0 | - |
| Respiratory system: Week 0 | 7 | - |
| Respiratory system: Week 0 | 0 | - |
| Respiratory system: Week 0 | 0 | - |
| Respiratory system: Week 16 | 7 | - |
| Respiratory system: Week 16 | 0 | - |
| Respiratory system: Week 16 | 0 | - |
| Cardiovascular system: Week 0 | 7 | - |
| Cardiovascular system: Week 0 | 0 | - |
| Cardiovascular system: Week 0 | 0 | - |
| Cardiovascular system: Week 16 | 7 | - |
| Cardiovascular system: Week 16 | 0 | - |
| Cardiovascular system: Week 16 | 0 | - |
| GI system including mouth: Week 0 | 7 | - |
| GI system including mouth: Week 0 | 0 | - |
| GI system including mouth: Week 0 | 0 | - |
| GI system including mouth: Week 16 | 7 | - |
| GI system including mouth: Week 16 | 0 | - |
| GI system including mouth: Week 16 | 0 | - |
| Musculoskeletal system: Week 0 | 6 | - |
| Musculoskeletal system: Week 0 | 1 | - |
| Musculoskeletal system: Week 0 | 0 | - |
| Musculoskeletal system: Week 16 | 6 | - |
| Musculoskeletal system: Week 16 | 1 | - |
| Musculoskeletal system: Week 16 | 0 | - |
| CNS and PNS: Week 0 | 6 | - |
| CNS and PNS: Week 0 | 1 | - |
| CNS and PNS: Week 0 | 0 | - |
| CNS and PNS: Week 16 | 7 | - |
| CNS and PNS: Week 16 | 0 | - |
| CNS and PNS: Week 16 | 0 | - |
| Skin: Week 0 | 6 | - |
| Skin: Week 0 | 1 | - |
| Skin: Week 0 | 0 | - |
| Skin: Week 16 | 6 | - |
| Skin: Week 16 | 0 | - |
| Skin: Week 16 | 1 | - |
| Thyroid gland: Week 0 | 7 | - |
| Thyroid gland: Week 0 | 0 | - |
| Thyroid gland: Week 0 | 0 | - |
| Thyroid gland: Week 16 | 7 | - |
| Thyroid gland: Week 16 | 0 | - |
| Thyroid gland: Week 16 | 0 | - |
| Lymph node palpation: Week 0 | 7 | - |
| Lymph node palpation: Week 0 | 0 | - |
| Lymph node palpation: Week 0 | 0 | - |
| Lymph node palpation: Week 16 | 7 | - |
| Lymph node palpation: Week 16 | 0 | - |
| Lymph node palpation: Week 16 | 0 | - |
| Part A+B: LiraglutideGeneral Appearance: Week 0 | 26 | - |
| General Appearance: Week 0 | 5 | - |
| General Appearance: Week 0 | 6 | - |
| General Appearance: Week 16 | 25 | - |
| General Appearance: Week 16 | 5 | - |
| General Appearance: Week 16 | 4 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 34 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 3 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 0 | - |
| Head, ears, eyes, nose, throat, neck: Week 16 | 33 | - |
| Head, ears, eyes, nose, throat, neck: Week 16 | 1 | - |
| Head, ears, eyes, nose, throat, neck: Week 16 | 0 | - |
| Respiratory system: Week 0 | 36 | - |
| Respiratory system: Week 0 | 1 | - |
| Respiratory system: Week 0 | 0 | - |
| Respiratory system: Week 16 | 34 | - |
| Respiratory system: Week 16 | 0 | - |
| Respiratory system: Week 16 | 0 | - |
| Cardiovascular system: Week 0 | 36 | - |
| Cardiovascular system: Week 0 | 1 | - |
| Cardiovascular system: Week 0 | 0 | - |
| Cardiovascular system: Week 16 | 33 | - |
| Cardiovascular system: Week 16 | 1 | - |
| Cardiovascular system: Week 16 | 0 | - |
| GI system including mouth: Week 0 | 36 | - |
| GI system including mouth: Week 0 | 1 | - |
| GI system including mouth: Week 0 | 0 | - |
| GI system including mouth: Week 16 | 32 | - |
| GI system including mouth: Week 16 | 2 | - |
| GI system including mouth: Week 16 | 0 | - |
| Musculoskeletal system: Week 0 | 29 | - |
| Musculoskeletal system: Week 0 | 6 | - |
| Musculoskeletal system: Week 0 | 2 | - |
| Musculoskeletal system: Week 16 | 27 | - |
| Musculoskeletal system: Week 16 | 6 | - |
| Musculoskeletal system: Week 16 | 1 | - |
| CNS and PNS: Week 0 | 31 | - |
| CNS and PNS: Week 0 | 3 | - |
| CNS and PNS: Week 0 | 3 | - |
| CNS and PNS: Week 16 | 29 | - |
| CNS and PNS: Week 16 | 3 | - |
| CNS and PNS: Week 16 | 2 | - |
| Skin: Week 0 | 21 | - |
| Skin: Week 0 | 12 | - |
| Skin: Week 0 | 4 | - |
| Skin: Week 16 | 22 | - |
| Skin: Week 16 | 10 | - |
| Skin: Week 16 | 2 | - |
| Thyroid gland: Week 0 | 37 | - |
| Thyroid gland: Week 0 | 0 | - |
| Thyroid gland: Week 0 | 0 | - |
| Thyroid gland: Week 16 | 34 | - |
| Thyroid gland: Week 16 | 0 | - |
| Thyroid gland: Week 16 | 0 | - |
| Lymph node palpation: Week 0 | 36 | - |
| Lymph node palpation: Week 0 | 1 | - |
| Lymph node palpation: Week 0 | 0 | - |
| Lymph node palpation: Week 16 | 34 | - |
| Lymph node palpation: Week 16 | 0 | - |
| Lymph node palpation: Week 16 | 0 | - |
| Part A+B: PlaceboGeneral Appearance: Week 0 | 15 | - |
| General Appearance: Week 0 | 2 | - |
| General Appearance: Week 0 | 2 | - |
| General Appearance: Week 16 | 16 | - |
| General Appearance: Week 16 | 1 | - |
| General Appearance: Week 16 | 2 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 16 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 3 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 0 | - |
| Head, ears, eyes, nose, throat, neck: Week 16 | 19 | - |
| Head, ears, eyes, nose, throat, neck: Week 16 | 0 | - |
| Head, ears, eyes, nose, throat, neck: Week 16 | 0 | - |
| Respiratory system: Week 0 | 19 | - |
| Respiratory system: Week 0 | 0 | - |
| Respiratory system: Week 0 | 0 | - |
| Respiratory system: Week 16 | 19 | - |
| Respiratory system: Week 16 | 0 | - |
| Respiratory system: Week 16 | 0 | - |
| Cardiovascular system: Week 0 | 19 | - |
| Cardiovascular system: Week 0 | 0 | - |
| Cardiovascular system: Week 0 | 0 | - |
| Cardiovascular system: Week 16 | 19 | - |
| Cardiovascular system: Week 16 | 0 | - |
| Cardiovascular system: Week 16 | 0 | - |
| GI system including mouth: Week 0 | 19 | - |
| GI system including mouth: Week 0 | 0 | - |
| GI system including mouth: Week 0 | 0 | - |
| GI system including mouth: Week 16 | 19 | - |
| GI system including mouth: Week 16 | 0 | - |
| GI system including mouth: Week 16 | 0 | - |
| Musculoskeletal system: Week 0 | 15 | - |
| Musculoskeletal system: Week 0 | 3 | - |
| Musculoskeletal system: Week 0 | 1 | - |
| Musculoskeletal system: Week 16 | 15 | - |
| Musculoskeletal system: Week 16 | 2 | - |
| Musculoskeletal system: Week 16 | 2 | - |
| CNS and PNS: Week 0 | 16 | - |
| CNS and PNS: Week 0 | 1 | - |
| CNS and PNS: Week 0 | 2 | - |
| CNS and PNS: Week 16 | 18 | - |
| CNS and PNS: Week 16 | 0 | - |
| CNS and PNS: Week 16 | 1 | - |
| Skin: Week 0 | 13 | - |
| Skin: Week 0 | 5 | - |
| Skin: Week 0 | 1 | - |
| Skin: Week 16 | 14 | - |
| Skin: Week 16 | 3 | - |
| Skin: Week 16 | 2 | - |
| Thyroid gland: Week 0 | 19 | - |
| Thyroid gland: Week 0 | 0 | - |
| Thyroid gland: Week 0 | 0 | - |
| Thyroid gland: Week 16 | 19 | - |
| Thyroid gland: Week 16 | 0 | - |
| Thyroid gland: Week 16 | 0 | - |
| Lymph node palpation: Week 0 | 19 | - |
| Lymph node palpation: Week 0 | 0 | - |
| Lymph node palpation: Week 0 | 0 | - |
| Lymph node palpation: Week 16 | 19 | - |
| Lymph node palpation: Week 16 | 0 | - |
| Lymph node palpation: Week 16 | 0 | - |
Number of Participants With Change in Physical Examination From Baseline at Week 52
Time frame:Week 0, week 52
descriptive
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Part A: LiraglutideGeneral Appearance: Week 0 | 14 | - |
| General Appearance: Week 0 | 2 | - |
| General Appearance: Week 0 | 4 | - |
| General Appearance: Week 52 | 13 | - |
| General Appearance: Week 52 | 1 | - |
| General Appearance: Week 52 | 3 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 19 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 1 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 0 | - |
| Head, ears, eyes, nose, throat, neck: Week 52 | 15 | - |
| Head, ears, eyes, nose, throat, neck: Week 52 | 2 | - |
| Head, ears, eyes, nose, throat, neck: Week 52 | 0 | - |
| Respiratory system: Week 0 | 20 | - |
| Respiratory system: Week 0 | 0 | - |
| Respiratory system: Week 0 | 0 | - |
| Cardiovascular system: Week 0 | 19 | - |
| Cardiovascular system: Week 0 | 1 | - |
| Cardiovascular system: Week 0 | 0 | - |
| Cardiovascular system: Week 52 | 17 | - |
| Cardiovascular system: Week 52 | 0 | - |
| Cardiovascular system: Week 52 | 0 | - |
| GI system including mouth: Week 0 | 19 | - |
| GI system including mouth: Week 0 | 1 | - |
| GI system including mouth: Week 0 | 0 | - |
| GI system including mouth: Week 52 | 16 | - |
| GI system including mouth: Week 52 | 1 | - |
| GI system including mouth: Week 52 | 0 | - |
| Musculoskeletal system: Week 0 | 15 | - |
| Musculoskeletal system: Week 0 | 3 | - |
| Musculoskeletal system: Week 0 | 2 | - |
| Musculoskeletal system: Week 52 | 15 | - |
| Musculoskeletal system: Week 52 | 1 | - |
| Musculoskeletal system: Week 52 | 1 | - |
| CNS and PNS: Week 0 | 16 | - |
| CNS and PNS: Week 0 | 2 | - |
| CNS and PNS: Week 0 | 2 | - |
| CNS and PNS: Week 52 | 13 | - |
| CNS and PNS: Week 52 | 1 | - |
| CNS and PNS: Week 52 | 2 | - |
| Skin: Week 0 | 11 | - |
| Skin: Week 0 | 6 | - |
| Skin: Week 0 | 3 | - |
| Skin: Week 52 | 13 | - |
| Skin: Week 52 | 3 | - |
| Skin: Week 52 | 1 | - |
| Thyroid gland: Week 0 | 20 | - |
| Thyroid gland: Week 0 | 0 | - |
| Thyroid gland: Week 0 | 0 | - |
| Thyroid gland: Week 52 | 17 | - |
| Thyroid gland: Week 52 | 0 | - |
| Thyroid gland: Week 52 | 0 | - |
| Lymph node palpation: Week 0 | 19 | - |
| Lymph node palpation: Week 0 | 1 | - |
| Lymph node palpation: Week 0 | 0 | - |
| Lymph node palpation: Week 52 | 17 | - |
| Lymph node palpation: Week 52 | 0 | - |
| Lymph node palpation: Week 52 | 0 | - |
| Part A: PlaceboGeneral Appearance: Week 0 | 10 | - |
| General Appearance: Week 0 | 1 | - |
| General Appearance: Week 0 | 1 | - |
| General Appearance: Week 52 | 10 | - |
| General Appearance: Week 52 | 0 | - |
| General Appearance: Week 52 | 1 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 10 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 2 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 0 | - |
| Head, ears, eyes, nose, throat, neck: Week 52 | 11 | - |
| Head, ears, eyes, nose, throat, neck: Week 52 | 0 | - |
| Head, ears, eyes, nose, throat, neck: Week 52 | 0 | - |
| Respiratory system: Week 0 | 12 | - |
| Respiratory system: Week 0 | 0 | - |
| Respiratory system: Week 0 | 0 | - |
| Cardiovascular system: Week 0 | 12 | - |
| Cardiovascular system: Week 0 | 0 | - |
| Cardiovascular system: Week 0 | 0 | - |
| Cardiovascular system: Week 52 | 10 | - |
| Cardiovascular system: Week 52 | 0 | - |
| Cardiovascular system: Week 52 | 1 | - |
| GI system including mouth: Week 0 | 12 | - |
| GI system including mouth: Week 0 | 0 | - |
| GI system including mouth: Week 0 | 0 | - |
| GI system including mouth: Week 52 | 11 | - |
| GI system including mouth: Week 52 | 0 | - |
| GI system including mouth: Week 52 | 0 | - |
| Musculoskeletal system: Week 0 | 9 | - |
| Musculoskeletal system: Week 0 | 2 | - |
| Musculoskeletal system: Week 0 | 1 | - |
| Musculoskeletal system: Week 52 | 10 | - |
| Musculoskeletal system: Week 52 | 1 | - |
| Musculoskeletal system: Week 52 | 0 | - |
| CNS and PNS: Week 0 | 10 | - |
| CNS and PNS: Week 0 | 0 | - |
| CNS and PNS: Week 0 | 2 | - |
| CNS and PNS: Week 52 | 10 | - |
| CNS and PNS: Week 52 | 0 | - |
| CNS and PNS: Week 52 | 1 | - |
| Skin: Week 0 | 7 | - |
| Skin: Week 0 | 4 | - |
| Skin: Week 0 | 1 | - |
| Skin: Week 52 | 8 | - |
| Skin: Week 52 | 2 | - |
| Skin: Week 52 | 1 | - |
| Thyroid gland: Week 0 | 12 | - |
| Thyroid gland: Week 0 | 0 | - |
| Thyroid gland: Week 0 | 0 | - |
| Thyroid gland: Week 52 | 11 | - |
| Thyroid gland: Week 52 | 0 | - |
| Thyroid gland: Week 52 | 0 | - |
| Lymph node palpation: Week 0 | 12 | - |
| Lymph node palpation: Week 0 | 0 | - |
| Lymph node palpation: Week 0 | 0 | - |
| Lymph node palpation: Week 52 | 11 | - |
| Lymph node palpation: Week 52 | 0 | - |
| Lymph node palpation: Week 52 | 0 | - |
| Part B: LiraglutideGeneral Appearance: Week 0 | 12 | - |
| General Appearance: Week 0 | 3 | - |
| General Appearance: Week 0 | 2 | - |
| General Appearance: Week 52 | 9 | - |
| General Appearance: Week 52 | 2 | - |
| General Appearance: Week 52 | 1 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 15 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 2 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 0 | - |
| Head, ears, eyes, nose, throat, neck: Week 52 | 12 | - |
| Head, ears, eyes, nose, throat, neck: Week 52 | 0 | - |
| Head, ears, eyes, nose, throat, neck: Week 52 | 0 | - |
| Respiratory system: Week 0 | 16 | - |
| Respiratory system: Week 0 | 1 | - |
| Respiratory system: Week 0 | 0 | - |
| Cardiovascular system: Week 0 | 17 | - |
| Cardiovascular system: Week 0 | 0 | - |
| Cardiovascular system: Week 0 | 0 | - |
| Cardiovascular system: Week 52 | 12 | - |
| Cardiovascular system: Week 52 | 0 | - |
| Cardiovascular system: Week 52 | 0 | - |
| GI system including mouth: Week 0 | 17 | - |
| GI system including mouth: Week 0 | 0 | - |
| GI system including mouth: Week 0 | 0 | - |
| GI system including mouth: Week 52 | 12 | - |
| GI system including mouth: Week 52 | 0 | - |
| GI system including mouth: Week 52 | 0 | - |
| Musculoskeletal system: Week 0 | 14 | - |
| Musculoskeletal system: Week 0 | 3 | - |
| Musculoskeletal system: Week 0 | 0 | - |
| Musculoskeletal system: Week 52 | 10 | - |
| Musculoskeletal system: Week 52 | 2 | - |
| Musculoskeletal system: Week 52 | 0 | - |
| CNS and PNS: Week 0 | 15 | - |
| CNS and PNS: Week 0 | 1 | - |
| CNS and PNS: Week 0 | 1 | - |
| CNS and PNS: Week 52 | 11 | - |
| CNS and PNS: Week 52 | 0 | - |
| CNS and PNS: Week 52 | 1 | - |
| Skin: Week 0 | 10 | - |
| Skin: Week 0 | 6 | - |
| Skin: Week 0 | 1 | - |
| Skin: Week 52 | 9 | - |
| Skin: Week 52 | 3 | - |
| Skin: Week 52 | 0 | - |
| Thyroid gland: Week 0 | 17 | - |
| Thyroid gland: Week 0 | 0 | - |
| Thyroid gland: Week 0 | 0 | - |
| Thyroid gland: Week 52 | 12 | - |
| Thyroid gland: Week 52 | 0 | - |
| Thyroid gland: Week 52 | 0 | - |
| Lymph node palpation: Week 0 | 17 | - |
| Lymph node palpation: Week 0 | 0 | - |
| Lymph node palpation: Week 0 | 0 | - |
| Lymph node palpation: Week 52 | 12 | - |
| Lymph node palpation: Week 52 | 0 | - |
| Lymph node palpation: Week 52 | 0 | - |
| Part B: PlaceboGeneral Appearance: Week 0 | 5 | - |
| General Appearance: Week 0 | 1 | - |
| General Appearance: Week 0 | 1 | - |
| General Appearance: Week 52 | 5 | - |
| General Appearance: Week 52 | 0 | - |
| General Appearance: Week 52 | 0 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 6 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 1 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 0 | - |
| Head, ears, eyes, nose, throat, neck: Week 52 | 4 | - |
| Head, ears, eyes, nose, throat, neck: Week 52 | 1 | - |
| Head, ears, eyes, nose, throat, neck: Week 52 | 0 | - |
| Respiratory system: Week 0 | 7 | - |
| Respiratory system: Week 0 | 0 | - |
| Respiratory system: Week 0 | 0 | - |
| Cardiovascular system: Week 0 | 7 | - |
| Cardiovascular system: Week 0 | 0 | - |
| Cardiovascular system: Week 0 | 0 | - |
| Cardiovascular system: Week 52 | 5 | - |
| Cardiovascular system: Week 52 | 0 | - |
| Cardiovascular system: Week 52 | 0 | - |
| GI system including mouth: Week 0 | 7 | - |
| GI system including mouth: Week 0 | 0 | - |
| GI system including mouth: Week 0 | 0 | - |
| GI system including mouth: Week 52 | 5 | - |
| GI system including mouth: Week 52 | 0 | - |
| GI system including mouth: Week 52 | 0 | - |
| Musculoskeletal system: Week 0 | 6 | - |
| Musculoskeletal system: Week 0 | 1 | - |
| Musculoskeletal system: Week 0 | 0 | - |
| Musculoskeletal system: Week 52 | 5 | - |
| Musculoskeletal system: Week 52 | 0 | - |
| Musculoskeletal system: Week 52 | 0 | - |
| CNS and PNS: Week 0 | 6 | - |
| CNS and PNS: Week 0 | 1 | - |
| CNS and PNS: Week 0 | 0 | - |
| CNS and PNS: Week 52 | 4 | - |
| CNS and PNS: Week 52 | 1 | - |
| CNS and PNS: Week 52 | 0 | - |
| Skin: Week 0 | 6 | - |
| Skin: Week 0 | 1 | - |
| Skin: Week 0 | 0 | - |
| Skin: Week 52 | 4 | - |
| Skin: Week 52 | 0 | - |
| Skin: Week 52 | 1 | - |
| Thyroid gland: Week 0 | 7 | - |
| Thyroid gland: Week 0 | 0 | - |
| Thyroid gland: Week 0 | 0 | - |
| Thyroid gland: Week 52 | 5 | - |
| Thyroid gland: Week 52 | 0 | - |
| Thyroid gland: Week 52 | 0 | - |
| Lymph node palpation: Week 0 | 7 | - |
| Lymph node palpation: Week 0 | 0 | - |
| Lymph node palpation: Week 0 | 0 | - |
| Lymph node palpation: Week 52 | 5 | - |
| Lymph node palpation: Week 52 | 0 | - |
| Lymph node palpation: Week 52 | 0 | - |
| Part A+B: LiraglutideGeneral Appearance: Week 0 | 26 | - |
| General Appearance: Week 0 | 5 | - |
| General Appearance: Week 0 | 6 | - |
| General Appearance: Week 52 | 22 | - |
| General Appearance: Week 52 | 3 | - |
| General Appearance: Week 52 | 4 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 34 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 3 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 0 | - |
| Head, ears, eyes, nose, throat, neck: Week 52 | 27 | - |
| Head, ears, eyes, nose, throat, neck: Week 52 | 2 | - |
| Head, ears, eyes, nose, throat, neck: Week 52 | 0 | - |
| Respiratory system: Week 0 | 36 | - |
| Respiratory system: Week 0 | 1 | - |
| Respiratory system: Week 0 | 0 | - |
| Cardiovascular system: Week 0 | 36 | - |
| Cardiovascular system: Week 0 | 1 | - |
| Cardiovascular system: Week 0 | 0 | - |
| Cardiovascular system: Week 52 | 29 | - |
| Cardiovascular system: Week 52 | 0 | - |
| Cardiovascular system: Week 52 | 0 | - |
| GI system including mouth: Week 0 | 36 | - |
| GI system including mouth: Week 0 | 1 | - |
| GI system including mouth: Week 0 | 0 | - |
| GI system including mouth: Week 52 | 28 | - |
| GI system including mouth: Week 52 | 1 | - |
| GI system including mouth: Week 52 | 0 | - |
| Musculoskeletal system: Week 0 | 29 | - |
| Musculoskeletal system: Week 0 | 6 | - |
| Musculoskeletal system: Week 0 | 2 | - |
| Musculoskeletal system: Week 52 | 25 | - |
| Musculoskeletal system: Week 52 | 3 | - |
| Musculoskeletal system: Week 52 | 1 | - |
| CNS and PNS: Week 0 | 31 | - |
| CNS and PNS: Week 0 | 3 | - |
| CNS and PNS: Week 0 | 3 | - |
| CNS and PNS: Week 52 | 24 | - |
| CNS and PNS: Week 52 | 1 | - |
| CNS and PNS: Week 52 | 3 | - |
| Skin: Week 0 | 21 | - |
| Skin: Week 0 | 12 | - |
| Skin: Week 0 | 4 | - |
| Skin: Week 52 | 22 | - |
| Skin: Week 52 | 6 | - |
| Skin: Week 52 | 1 | - |
| Thyroid gland: Week 0 | 37 | - |
| Thyroid gland: Week 0 | 0 | - |
| Thyroid gland: Week 0 | 0 | - |
| Thyroid gland: Week 52 | 29 | - |
| Thyroid gland: Week 52 | 0 | - |
| Thyroid gland: Week 52 | 0 | - |
| Lymph node palpation: Week 0 | 36 | - |
| Lymph node palpation: Week 0 | 1 | - |
| Lymph node palpation: Week 0 | 0 | - |
| Lymph node palpation: Week 52 | 29 | - |
| Lymph node palpation: Week 52 | 0 | - |
| Lymph node palpation: Week 52 | 0 | - |
| Part A+B: PlaceboGeneral Appearance: Week 0 | 15 | - |
| General Appearance: Week 0 | 2 | - |
| General Appearance: Week 0 | 2 | - |
| General Appearance: Week 52 | 15 | - |
| General Appearance: Week 52 | 0 | - |
| General Appearance: Week 52 | 1 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 16 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 3 | - |
| Head, ears, eyes, nose, throat, neck: Week 0 | 0 | - |
| Head, ears, eyes, nose, throat, neck: Week 52 | 15 | - |
| Head, ears, eyes, nose, throat, neck: Week 52 | 1 | - |
| Head, ears, eyes, nose, throat, neck: Week 52 | 0 | - |
| Respiratory system: Week 0 | 19 | - |
| Respiratory system: Week 0 | 0 | - |
| Respiratory system: Week 0 | 0 | - |
| Cardiovascular system: Week 0 | 19 | - |
| Cardiovascular system: Week 0 | 0 | - |
| Cardiovascular system: Week 0 | 0 | - |
| Cardiovascular system: Week 52 | 15 | - |
| Cardiovascular system: Week 52 | 0 | - |
| Cardiovascular system: Week 52 | 1 | - |
| GI system including mouth: Week 0 | 19 | - |
| GI system including mouth: Week 0 | 0 | - |
| GI system including mouth: Week 0 | 0 | - |
| GI system including mouth: Week 52 | 16 | - |
| GI system including mouth: Week 52 | 0 | - |
| GI system including mouth: Week 52 | 0 | - |
| Musculoskeletal system: Week 0 | 15 | - |
| Musculoskeletal system: Week 0 | 3 | - |
| Musculoskeletal system: Week 0 | 1 | - |
| Musculoskeletal system: Week 52 | 15 | - |
| Musculoskeletal system: Week 52 | 1 | - |
| Musculoskeletal system: Week 52 | 0 | - |
| CNS and PNS: Week 0 | 16 | - |
| CNS and PNS: Week 0 | 1 | - |
| CNS and PNS: Week 0 | 2 | - |
| CNS and PNS: Week 52 | 14 | - |
| CNS and PNS: Week 52 | 1 | - |
| CNS and PNS: Week 52 | 1 | - |
| Skin: Week 0 | 13 | - |
| Skin: Week 0 | 5 | - |
| Skin: Week 0 | 1 | - |
| Skin: Week 52 | 12 | - |
| Skin: Week 52 | 2 | - |
| Skin: Week 52 | 2 | - |
| Thyroid gland: Week 0 | 19 | - |
| Thyroid gland: Week 0 | 0 | - |
| Thyroid gland: Week 0 | 0 | - |
| Thyroid gland: Week 52 | 16 | - |
| Thyroid gland: Week 52 | 0 | - |
| Thyroid gland: Week 52 | 0 | - |
| Lymph node palpation: Week 0 | 19 | - |
| Lymph node palpation: Week 0 | 0 | - |
| Lymph node palpation: Week 0 | 0 | - |
| Lymph node palpation: Week 52 | 16 | - |
| Lymph node palpation: Week 52 | 0 | - |
| Lymph node palpation: Week 52 | 0 | - |
Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 16
Time frame:Week 0, week 16
threshold achievement, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Part A: LiraglutideWeek 0: Suicidal ideation | 1 | - |
| Week 0: Suicidal behaviour | 0 | - |
| Week 16: Suicidal ideation | 1 | - |
| Week 16: Suicidal behaviour | 0 | - |
| Part A: PlaceboWeek 0: Suicidal ideation | 3 | - |
| Week 0: Suicidal behaviour | 0 | - |
| Week 16: Suicidal ideation | 1 | - |
| Week 16: Suicidal behaviour | 0 | - |
Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 52
Time frame:Week 0, week 52
threshold achievement, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Part A: LiraglutideWeek 0: Suicidal ideation | 1 | - |
| Week 0: Suicidal behaviour | 0 | - |
| Week 52: Suicidal ideation | 1 | - |
| Week 52: Suicidal behaviour | 0 | - |
| Part A: PlaceboWeek 0: Suicidal ideation | 3 | - |
| Week 0: Suicidal behaviour | 0 | - |
| Week 52: Suicidal ideation | 0 | - |
| Week 52: Suicidal behaviour | 0 | - |
Number of Treatment Emergent Adverse Events
Time frame:From week 0 to week 54
Treatment-emergent AEs (any)
event count, event
Number of Severe Treatment Emergent Episodes of Hypoglycaemia
Time frame:From week 0 to week 54
Severe hypoglycemia
event count, event
Number of Blood Glucose Confirmed Symptomatic Episodes of Hypoglycaemia
Time frame:From week 0 to week 54
Documented hypoglycemia
event count, event
Number of Participants With Occurrence of Anti-liraglutide Antibodies
Time frame:From week 0 to week 54
Immunogenicity (ADA)
categorical status, event
Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16
Time frame:Week 0, Week 16
categorical status, descriptive
Number of Participants With Change in ECG From Baseline at Week 52
Time frame:Week 0, Week 52
categorical status, descriptive
Change in Haematology: Haemoglobin From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
Change in Haematology: Haemoglobin From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, descriptive
Change in Haematology: Haematocrit From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
Change in Haematology: Haematocrit From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, descriptive
Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, descriptive
Change in Haematology: Erythrocytes From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
Change in Haematology: Erythrocytes From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, descriptive
Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, descriptive
Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, descriptive
Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, descriptive
Change in Hormone Level: Calcitonin From Baseline at Week 16
Time frame:Week 0, week 16
Thyroid event
change from baseline, descriptive
Change in Hormone Level: Calcitonin From Baseline at Week 52
Time frame:Week 0, week 52
Thyroid event
change from baseline, descriptive
Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
componentsthyroid stimulating hormone change, prolactin change
Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, descriptive
Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, descriptive
Number of Participants With Change in Physical Examination From Baseline at Week 16
Time frame:Week 0, week 16
descriptive
Number of Participants With Change in Physical Examination From Baseline at Week 52
Time frame:Week 0, week 52
descriptive
Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 16
Time frame:Week 0, week 16
descriptive, event
Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 52
Time frame:Week 0, week 52
categorical status, event
Other clinical outcomes
23 endpointsChange in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 16
Time frame:Week 0, week 16
Androgen, change
change from baseline, improvement
Posted result
| Group | Mean · umol/L | 95% CI |
|---|---|---|
| Part A: Liraglutide | 0.16 | - |
| Part A: Placebo | 0.21 | - |
| Part B: Liraglutide | 0.25 | - |
| Part B: Placebo | 1.00 | - |
| Part A+B: Liraglutide | 0.20 | - |
| Part A+B: Placebo | 0.46 | - |
Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 52
Time frame:Week 0, week 52
Androgen, change
change from baseline, improvement
Posted result
| Group | Mean · umol/L | 95% CI |
|---|---|---|
| Part A: Liraglutide | 0.77 | - |
| Part A: Placebo | 0.76 | - |
| Part B: Liraglutide | 0.25 | - |
| Part B: Placebo | 0.74 | - |
| Part A+B: Liraglutide | 0.55 | - |
| Part A+B: Placebo | 0.76 | - |
Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
Posted result
| Group | Mean · IU/L | 95% CI |
|---|---|---|
| Part A: LiraglutideLH: Change from week 0 to week 16 | -0.04 | - |
| FSH: Change from week 0 to week 16 | -0.2 | - |
| Part A: PlaceboLH: Change from week 0 to week 16 | 0.06 | - |
| FSH: Change from week 0 to week 16 | 0.2 | - |
| Part B: LiraglutideLH: Change from week 0 to week 16 | -0.07 | - |
| FSH: Change from week 0 to week 16 | -0.1 | - |
| Part B: PlaceboLH: Change from week 0 to week 16 | 0.22 | - |
| FSH: Change from week 0 to week 16 | 1.0 | - |
| Part A+B: LiraglutideLH: Change from week 0 to week 16 | -0.05 | - |
| FSH: Change from week 0 to week 16 | -0.2 | - |
| Part A+B: PlaceboLH: Change from week 0 to week 16 | 0.12 | - |
| FSH: Change from week 0 to week 16 | 0.5 | - |
Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, improvement
Posted result
| Group | Mean · IU/L | 95% CI |
|---|---|---|
| Part A: LiraglutideLH: Change from week 0 to week 52 | 0.16 | - |
| FSH: Change from week 0 to week 52 | 1.1 | - |
| Part A: PlaceboLH: Change from week 0 to week 52 | 0.06 | - |
| FSH: Change from week 0 to week 52 | 0.4 | - |
| Part B: LiraglutideLH: Change from week 0 to week 52 | 0.37 | - |
| FSH: Change from week 0 to week 52 | 0.4 | - |
| Part B: PlaceboLH: Change from week 0 to week 52 | 0.30 | - |
| FSH: Change from week 0 to week 52 | 0.7 | - |
| Part A+B: LiraglutideLH: Change from week 0 to week 52 | 0.24 | - |
| FSH: Change from week 0 to week 52 | 0.8 | - |
| Part A+B: PlaceboLH: Change from week 0 to week 52 | 0.14 | - |
| FSH: Change from week 0 to week 52 | 0.6 | - |
Change in Hormone Level: Estradiol (Females) From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
Posted result
| Group | Mean · picograms per milliliter (pg/mL) | 95% CI |
|---|---|---|
| Part A: Liraglutide | 0.9 | - |
| Part A: Placebo | 9.2 | - |
| Part B: Liraglutide | 1.6 | - |
| Part B: Placebo | 0 | - |
| Part A+B: Liraglutide | 1.2 | - |
| Part A+B: Placebo | 6.1 | - |
Change in Hormone Level: Estradiol (Females) From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, descriptive
Posted result
| Group | Mean · pg/mL | 95% CI |
|---|---|---|
| Part A: Liraglutide | 7.0 | - |
| Part A: Placebo | 13.7 | - |
| Part B: Liraglutide | 1.6 | - |
| Part B: Placebo | 0 | - |
| Part A+B: Liraglutide | 4.1 | - |
| Part A+B: Placebo | 11.0 | - |
Change in Hormone Level: Testosterone (Males) From Baseline at Week 16
Time frame:Week 0, week 16
Androgen, change
change from baseline, improvement
Posted result
| Group | Mean · nanomoles per liter (nmol/L) | 95% CI |
|---|---|---|
| Part A: Liraglutide | 1.55 | - |
| Part A: Placebo | 0.61 | - |
Change in Hormone Level: Testosterone (Males) From Baseline at Week 52
Time frame:Week 0, week 52
Androgen, change
change from baseline, improvement
Posted result
| Group | Mean · nmol/L | 95% CI |
|---|---|---|
| Part A: Liraglutide | 0.62 | - |
| Part A: Placebo | -0.34 | - |
Number of Participants With Change in Pubertal Status From Baseline at Week 16
Time frame:Week 0, week 16
categorical status, descriptive
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Part A: LiraglutideWeek 0: Breast development (for female) | 0 | - |
| Week 0: Breast development (for female) | 1 | - |
| Week 0: Breast development (for female) | 8 | - |
| Week 0: Breast development (for female) | 0 | - |
| Week 0: Breast development (for female) | 2 | - |
| Week 16: Breast development (for female) | 0 | - |
| Week 16: Breast development (for female) | 1 | - |
| Week 16: Breast development (for female) | 7 | - |
| Week 16: Breast development (for female) | 0 | - |
| Week 16: Breast development (for female) | 2 | - |
| Week 0: Pubic hair development (for female) | 1 | - |
| Week 0: Pubic hair development (for female) | 2 | - |
| Week 0: Pubic hair development (for female) | 3 | - |
| Week 0: Pubic hair development (for female) | 3 | - |
| Week 0: Pubic hair development (for female) | 2 | - |
| Week 16: Pubic hair development (for female) | 1 | - |
| Week 16: Pubic hair development (for female) | 1 | - |
| Week 16: Pubic hair development (for female) | 4 | - |
| Week 16: Pubic hair development (for female) | 2 | - |
| Week 16: Pubic hair development (for female) | 2 | - |
| Week 0: Pubic hair development (for male) | 0 | - |
| Week 0: Pubic hair development (for male) | 3 | - |
| Week 0: Pubic hair development (for male) | 2 | - |
| Week 0: Pubic hair development (for male) | 2 | - |
| Week 0: Pubic hair development (for male) | 2 | - |
| Week 16: Pubic hair development (for male) | 0 | - |
| Week 16: Pubic hair development (for male) | 2 | - |
| Week 16: Pubic hair development (for male) | 2 | - |
| Week 16: Pubic hair development (for male) | 2 | - |
| Week 16: Pubic hair development (for male) | 3 | - |
| Week 0: Penis development (for male) | 0 | - |
| Week 0: Penis development (for male) | 4 | - |
| Week 0: Penis development (for male) | 1 | - |
| Week 0: Penis development (for male) | 3 | - |
| Week 0: Penis development (for male) | 1 | - |
| Week 16: Penis development (for male) | 0 | - |
| Week 16: Penis development (for male) | 2 | - |
| Week 16: Penis development (for male) | 2 | - |
| Week 16: Penis development (for male) | 2 | - |
| Week 16: Penis development (for male) | 3 | - |
| Part A: PlaceboWeek 0: Breast development (for female) | 0 | - |
| Week 0: Breast development (for female) | 0 | - |
| Week 0: Breast development (for female) | 2 | - |
| Week 0: Breast development (for female) | 1 | - |
| Week 0: Breast development (for female) | 2 | - |
| Week 16: Breast development (for female) | 0 | - |
| Week 16: Breast development (for female) | 0 | - |
| Week 16: Breast development (for female) | 1 | - |
| Week 16: Breast development (for female) | 2 | - |
| Week 16: Breast development (for female) | 2 | - |
| Week 0: Pubic hair development (for female) | 0 | - |
| Week 0: Pubic hair development (for female) | 0 | - |
| Week 0: Pubic hair development (for female) | 2 | - |
| Week 0: Pubic hair development (for female) | 1 | - |
| Week 0: Pubic hair development (for female) | 2 | - |
| Week 16: Pubic hair development (for female) | 0 | - |
| Week 16: Pubic hair development (for female) | 0 | - |
| Week 16: Pubic hair development (for female) | 1 | - |
| Week 16: Pubic hair development (for female) | 2 | - |
| Week 16: Pubic hair development (for female) | 2 | - |
| Week 0: Pubic hair development (for male) | 0 | - |
| Week 0: Pubic hair development (for male) | 0 | - |
| Week 0: Pubic hair development (for male) | 4 | - |
| Week 0: Pubic hair development (for male) | 2 | - |
| Week 0: Pubic hair development (for male) | 1 | - |
| Week 16: Pubic hair development (for male) | 0 | - |
| Week 16: Pubic hair development (for male) | 0 | - |
| Week 16: Pubic hair development (for male) | 3 | - |
| Week 16: Pubic hair development (for male) | 2 | - |
| Week 16: Pubic hair development (for male) | 2 | - |
| Week 0: Penis development (for male) | 1 | - |
| Week 0: Penis development (for male) | 3 | - |
| Week 0: Penis development (for male) | 1 | - |
| Week 0: Penis development (for male) | 2 | - |
| Week 0: Penis development (for male) | 0 | - |
| Week 16: Penis development (for male) | 1 | - |
| Week 16: Penis development (for male) | 1 | - |
| Week 16: Penis development (for male) | 3 | - |
| Week 16: Penis development (for male) | 1 | - |
| Week 16: Penis development (for male) | 1 | - |
| Part B: LiraglutideWeek 0: Breast development (for female) | 11 | - |
| Week 0: Breast development (for female) | 0 | - |
| Week 0: Breast development (for female) | 0 | - |
| Week 0: Breast development (for female) | 0 | - |
| Week 0: Breast development (for female) | 0 | - |
| Week 16: Breast development (for female) | 6 | - |
| Week 16: Breast development (for female) | 3 | - |
| Week 16: Breast development (for female) | 0 | - |
| Week 16: Breast development (for female) | 0 | - |
| Week 16: Breast development (for female) | 0 | - |
| Week 0: Pubic hair development (for female) | 6 | - |
| Week 0: Pubic hair development (for female) | 3 | - |
| Week 0: Pubic hair development (for female) | 0 | - |
| Week 0: Pubic hair development (for female) | 2 | - |
| Week 0: Pubic hair development (for female) | 0 | - |
| Week 16: Pubic hair development (for female) | 3 | - |
| Week 16: Pubic hair development (for female) | 5 | - |
| Week 16: Pubic hair development (for female) | 0 | - |
| Week 16: Pubic hair development (for female) | 1 | - |
| Week 16: Pubic hair development (for female) | 0 | - |
| Week 0: Pubic hair development (for male) | 6 | - |
| Week 0: Pubic hair development (for male) | 0 | - |
| Week 0: Pubic hair development (for male) | 0 | - |
| Week 0: Pubic hair development (for male) | 0 | - |
| Week 0: Pubic hair development (for male) | 0 | - |
| Week 16: Pubic hair development (for male) | 6 | - |
| Week 16: Pubic hair development (for male) | 0 | - |
| Week 16: Pubic hair development (for male) | 0 | - |
| Week 16: Pubic hair development (for male) | 0 | - |
| Week 16: Pubic hair development (for male) | 0 | - |
| Week 0: Penis development (for male) | 6 | - |
| Week 0: Penis development (for male) | 0 | - |
| Week 0: Penis development (for male) | 0 | - |
| Week 0: Penis development (for male) | 0 | - |
| Week 0: Penis development (for male) | 0 | - |
| Week 16: Penis development (for male) | 5 | - |
| Week 16: Penis development (for male) | 1 | - |
| Week 16: Penis development (for male) | 0 | - |
| Week 16: Penis development (for male) | 0 | - |
| Week 16: Penis development (for male) | 0 | - |
| Part B: PlaceboWeek 0: Breast development (for female) | 2 | - |
| Week 0: Breast development (for female) | 0 | - |
| Week 0: Breast development (for female) | 0 | - |
| Week 0: Breast development (for female) | 0 | - |
| Week 0: Breast development (for female) | 0 | - |
| Week 16: Breast development (for female) | 2 | - |
| Week 16: Breast development (for female) | 0 | - |
| Week 16: Breast development (for female) | 0 | - |
| Week 16: Breast development (for female) | 0 | - |
| Week 16: Breast development (for female) | 0 | - |
| Week 0: Pubic hair development (for female) | 1 | - |
| Week 0: Pubic hair development (for female) | 0 | - |
| Week 0: Pubic hair development (for female) | 1 | - |
| Week 0: Pubic hair development (for female) | 0 | - |
| Week 0: Pubic hair development (for female) | 0 | - |
| Week 16: Pubic hair development (for female) | 1 | - |
| Week 16: Pubic hair development (for female) | 0 | - |
| Week 16: Pubic hair development (for female) | 1 | - |
| Week 16: Pubic hair development (for female) | 0 | - |
| Week 16: Pubic hair development (for female) | 0 | - |
| Week 0: Pubic hair development (for male) | 3 | - |
| Week 0: Pubic hair development (for male) | 1 | - |
| Week 0: Pubic hair development (for male) | 1 | - |
| Week 0: Pubic hair development (for male) | 0 | - |
| Week 0: Pubic hair development (for male) | 0 | - |
| Week 16: Pubic hair development (for male) | 1 | - |
| Week 16: Pubic hair development (for male) | 3 | - |
| Week 16: Pubic hair development (for male) | 1 | - |
| Week 16: Pubic hair development (for male) | 0 | - |
| Week 16: Pubic hair development (for male) | 0 | - |
| Week 0: Penis development (for male) | 5 | - |
| Week 0: Penis development (for male) | 0 | - |
| Week 0: Penis development (for male) | 0 | - |
| Week 0: Penis development (for male) | 0 | - |
| Week 0: Penis development (for male) | 0 | - |
| Week 16: Penis development (for male) | 5 | - |
| Week 16: Penis development (for male) | 0 | - |
| Week 16: Penis development (for male) | 0 | - |
| Week 16: Penis development (for male) | 0 | - |
| Week 16: Penis development (for male) | 0 | - |
| Part A+B: LiraglutideWeek 0: Breast development (for female) | 11 | - |
| Week 0: Breast development (for female) | 1 | - |
| Week 0: Breast development (for female) | 8 | - |
| Week 0: Breast development (for female) | 0 | - |
| Week 0: Breast development (for female) | 2 | - |
| Week 16: Breast development (for female) | 6 | - |
| Week 16: Breast development (for female) | 4 | - |
| Week 16: Breast development (for female) | 7 | - |
| Week 16: Breast development (for female) | 0 | - |
| Week 16: Breast development (for female) | 2 | - |
| Week 0: Pubic hair development (for female) | 7 | - |
| Week 0: Pubic hair development (for female) | 5 | - |
| Week 0: Pubic hair development (for female) | 3 | - |
| Week 0: Pubic hair development (for female) | 5 | - |
| Week 0: Pubic hair development (for female) | 2 | - |
| Week 16: Pubic hair development (for female) | 4 | - |
| Week 16: Pubic hair development (for female) | 6 | - |
| Week 16: Pubic hair development (for female) | 4 | - |
| Week 16: Pubic hair development (for female) | 3 | - |
| Week 16: Pubic hair development (for female) | 2 | - |
| Week 0: Pubic hair development (for male) | 6 | - |
| Week 0: Pubic hair development (for male) | 3 | - |
| Week 0: Pubic hair development (for male) | 2 | - |
| Week 0: Pubic hair development (for male) | 2 | - |
| Week 0: Pubic hair development (for male) | 2 | - |
| Week 16: Pubic hair development (for male) | 6 | - |
| Week 16: Pubic hair development (for male) | 2 | - |
| Week 16: Pubic hair development (for male) | 2 | - |
| Week 16: Pubic hair development (for male) | 2 | - |
| Week 16: Pubic hair development (for male) | 3 | - |
| Week 0: Penis development (for male) | 6 | - |
| Week 0: Penis development (for male) | 4 | - |
| Week 0: Penis development (for male) | 1 | - |
| Week 0: Penis development (for male) | 3 | - |
| Week 0: Penis development (for male) | 1 | - |
| Week 16: Penis development (for male) | 5 | - |
| Week 16: Penis development (for male) | 3 | - |
| Week 16: Penis development (for male) | 2 | - |
| Week 16: Penis development (for male) | 2 | - |
| Week 16: Penis development (for male) | 3 | - |
| Part A+B: PlaceboWeek 0: Breast development (for female) | 2 | - |
| Week 0: Breast development (for female) | 0 | - |
| Week 0: Breast development (for female) | 2 | - |
| Week 0: Breast development (for female) | 1 | - |
| Week 0: Breast development (for female) | 2 | - |
| Week 16: Breast development (for female) | 2 | - |
| Week 16: Breast development (for female) | 0 | - |
| Week 16: Breast development (for female) | 1 | - |
| Week 16: Breast development (for female) | 2 | - |
| Week 16: Breast development (for female) | 2 | - |
| Week 0: Pubic hair development (for female) | 1 | - |
| Week 0: Pubic hair development (for female) | 0 | - |
| Week 0: Pubic hair development (for female) | 3 | - |
| Week 0: Pubic hair development (for female) | 1 | - |
| Week 0: Pubic hair development (for female) | 2 | - |
| Week 16: Pubic hair development (for female) | 1 | - |
| Week 16: Pubic hair development (for female) | 0 | - |
| Week 16: Pubic hair development (for female) | 2 | - |
| Week 16: Pubic hair development (for female) | 2 | - |
| Week 16: Pubic hair development (for female) | 2 | - |
| Week 0: Pubic hair development (for male) | 3 | - |
| Week 0: Pubic hair development (for male) | 1 | - |
| Week 0: Pubic hair development (for male) | 5 | - |
| Week 0: Pubic hair development (for male) | 2 | - |
| Week 0: Pubic hair development (for male) | 1 | - |
| Week 16: Pubic hair development (for male) | 1 | - |
| Week 16: Pubic hair development (for male) | 3 | - |
| Week 16: Pubic hair development (for male) | 4 | - |
| Week 16: Pubic hair development (for male) | 2 | - |
| Week 16: Pubic hair development (for male) | 2 | - |
| Week 0: Penis development (for male) | 6 | - |
| Week 0: Penis development (for male) | 3 | - |
| Week 0: Penis development (for male) | 1 | - |
| Week 0: Penis development (for male) | 2 | - |
| Week 0: Penis development (for male) | 0 | - |
| Week 16: Penis development (for male) | 6 | - |
| Week 16: Penis development (for male) | 1 | - |
| Week 16: Penis development (for male) | 3 | - |
| Week 16: Penis development (for male) | 1 | - |
| Week 16: Penis development (for male) | 1 | - |
Number of Participants With Change in Pubertal Status From Baseline at Week 52
Time frame:Week 0, week 52
categorical status, descriptive
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Part A: LiraglutideWeek 0: Breast development (for female) | 0 | - |
| Week 0: Breast development (for female) | 1 | - |
| Week 0: Breast development (for female) | 8 | - |
| Week 0: Breast development (for female) | 0 | - |
| Week 0: Breast development (for female) | 2 | - |
| Week 52: Breast development (for female) | 0 | - |
| Week 52: Breast development (for female) | 0 | - |
| Week 52: Breast development (for female) | 5 | - |
| Week 52: Breast development (for female) | 1 | - |
| Week 52: Breast development (for female) | 3 | - |
| Week 0: Pubic hair development (for female) | 1 | - |
| Week 0: Pubic hair development (for female) | 2 | - |
| Week 0: Pubic hair development (for female) | 3 | - |
| Week 0: Pubic hair development (for female) | 3 | - |
| Week 0: Pubic hair development (for female) | 2 | - |
| Week 52: Pubic hair development (for female) | 1 | - |
| Week 52: Pubic hair development (for female) | 1 | - |
| Week 52: Pubic hair development (for female) | 2 | - |
| Week 52: Pubic hair development (for female) | 3 | - |
| Week 52: Pubic hair development (for female) | 2 | - |
| Week 0: Pubic hair development (for male) | 0 | - |
| Week 0: Pubic hair development (for male) | 3 | - |
| Week 0: Pubic hair development (for male) | 2 | - |
| Week 0: Pubic hair development (for male) | 2 | - |
| Week 0: Pubic hair development (for male) | 2 | - |
| Week 52: Pubic hair development (for male) | 0 | - |
| Week 52: Pubic hair development (for male) | 0 | - |
| Week 52: Pubic hair development (for male) | 3 | - |
| Week 52: Pubic hair development (for male) | 3 | - |
| Week 52: Pubic hair development (for male) | 3 | - |
| Week 0: Penis development (for male) | 0 | - |
| Week 0: Penis development (for male) | 4 | - |
| Week 0: Penis development (for male) | 1 | - |
| Week 0: Penis development (for male) | 3 | - |
| Week 0: Penis development (for male) | 1 | - |
| Week 52: Penis development (for male) | 0 | - |
| Week 52: Penis development (for male) | 1 | - |
| Week 52: Penis development (for male) | 2 | - |
| Week 52: Penis development (for male) | 3 | - |
| Week 52: Penis development (for male) | 3 | - |
| Part A: PlaceboWeek 0: Breast development (for female) | 0 | - |
| Week 0: Breast development (for female) | 0 | - |
| Week 0: Breast development (for female) | 2 | - |
| Week 0: Breast development (for female) | 1 | - |
| Week 0: Breast development (for female) | 2 | - |
| Week 52: Breast development (for female) | 0 | - |
| Week 52: Breast development (for female) | 0 | - |
| Week 52: Breast development (for female) | 1 | - |
| Week 52: Breast development (for female) | 2 | - |
| Week 52: Breast development (for female) | 2 | - |
| Week 0: Pubic hair development (for female) | 0 | - |
| Week 0: Pubic hair development (for female) | 0 | - |
| Week 0: Pubic hair development (for female) | 2 | - |
| Week 0: Pubic hair development (for female) | 1 | - |
| Week 0: Pubic hair development (for female) | 2 | - |
| Week 52: Pubic hair development (for female) | 0 | - |
| Week 52: Pubic hair development (for female) | 0 | - |
| Week 52: Pubic hair development (for female) | 1 | - |
| Week 52: Pubic hair development (for female) | 2 | - |
| Week 52: Pubic hair development (for female) | 2 | - |
| Week 0: Pubic hair development (for male) | 0 | - |
| Week 0: Pubic hair development (for male) | 0 | - |
| Week 0: Pubic hair development (for male) | 4 | - |
| Week 0: Pubic hair development (for male) | 2 | - |
| Week 0: Pubic hair development (for male) | 1 | - |
| Week 52: Pubic hair development (for male) | 0 | - |
| Week 52: Pubic hair development (for male) | 0 | - |
| Week 52: Pubic hair development (for male) | 2 | - |
| Week 52: Pubic hair development (for male) | 3 | - |
| Week 52: Pubic hair development (for male) | 1 | - |
| Week 0: Penis development (for male) | 1 | - |
| Week 0: Penis development (for male) | 3 | - |
| Week 0: Penis development (for male) | 1 | - |
| Week 0: Penis development (for male) | 2 | - |
| Week 0: Penis development (for male) | 0 | - |
| Week 52: Penis development (for male) | 1 | - |
| Week 52: Penis development (for male) | 1 | - |
| Week 52: Penis development (for male) | 1 | - |
| Week 52: Penis development (for male) | 2 | - |
| Week 52: Penis development (for male) | 1 | - |
| Part B: LiraglutideWeek 0: Breast development (for female) | 11 | - |
| Week 0: Breast development (for female) | 0 | - |
| Week 0: Breast development (for female) | 0 | - |
| Week 0: Breast development (for female) | 0 | - |
| Week 0: Breast development (for female) | 0 | - |
| Week 52: Breast development (for female) | 2 | - |
| Week 52: Breast development (for female) | 4 | - |
| Week 52: Breast development (for female) | 2 | - |
| Week 52: Breast development (for female) | 0 | - |
| Week 52: Breast development (for female) | 0 | - |
| Week 0: Pubic hair development (for female) | 6 | - |
| Week 0: Pubic hair development (for female) | 3 | - |
| Week 0: Pubic hair development (for female) | 0 | - |
| Week 0: Pubic hair development (for female) | 2 | - |
| Week 0: Pubic hair development (for female) | 0 | - |
| Week 52: Pubic hair development (for female) | 1 | - |
| Week 52: Pubic hair development (for female) | 2 | - |
| Week 52: Pubic hair development (for female) | 4 | - |
| Week 52: Pubic hair development (for female) | 1 | - |
| Week 52: Pubic hair development (for female) | 0 | - |
| Week 0: Pubic hair development (for male) | 6 | - |
| Week 0: Pubic hair development (for male) | 0 | - |
| Week 0: Pubic hair development (for male) | 0 | - |
| Week 0: Pubic hair development (for male) | 0 | - |
| Week 0: Pubic hair development (for male) | 0 | - |
| Week 52: Pubic hair development (for male) | 4 | - |
| Week 52: Pubic hair development (for male) | 1 | - |
| Week 52: Pubic hair development (for male) | 0 | - |
| Week 52: Pubic hair development (for male) | 0 | - |
| Week 52: Pubic hair development (for male) | 0 | - |
| Week 0: Penis development (for male) | 6 | - |
| Week 0: Penis development (for male) | 0 | - |
| Week 0: Penis development (for male) | 0 | - |
| Week 0: Penis development (for male) | 0 | - |
| Week 0: Penis development (for male) | 0 | - |
| Week 52: Penis development (for male) | 3 | - |
| Week 52: Penis development (for male) | 2 | - |
| Week 52: Penis development (for male) | 0 | - |
| Week 52: Penis development (for male) | 0 | - |
| Week 52: Penis development (for male) | 0 | - |
| Part B: PlaceboWeek 0: Breast development (for female) | 2 | - |
| Week 0: Breast development (for female) | 0 | - |
| Week 0: Breast development (for female) | 0 | - |
| Week 0: Breast development (for female) | 0 | - |
| Week 0: Breast development (for female) | 0 | - |
| Week 52: Breast development (for female) | 1 | - |
| Week 52: Breast development (for female) | 0 | - |
| Week 52: Breast development (for female) | 0 | - |
| Week 52: Breast development (for female) | 0 | - |
| Week 52: Breast development (for female) | 0 | - |
| Week 0: Pubic hair development (for female) | 1 | - |
| Week 0: Pubic hair development (for female) | 0 | - |
| Week 0: Pubic hair development (for female) | 1 | - |
| Week 0: Pubic hair development (for female) | 0 | - |
| Week 0: Pubic hair development (for female) | 0 | - |
| Week 52: Pubic hair development (for female) | 0 | - |
| Week 52: Pubic hair development (for female) | 0 | - |
| Week 52: Pubic hair development (for female) | 1 | - |
| Week 52: Pubic hair development (for female) | 0 | - |
| Week 52: Pubic hair development (for female) | 0 | - |
| Week 0: Pubic hair development (for male) | 3 | - |
| Week 0: Pubic hair development (for male) | 1 | - |
| Week 0: Pubic hair development (for male) | 1 | - |
| Week 0: Pubic hair development (for male) | 0 | - |
| Week 0: Pubic hair development (for male) | 0 | - |
| Week 52: Pubic hair development (for male) | 0 | - |
| Week 52: Pubic hair development (for male) | 1 | - |
| Week 52: Pubic hair development (for male) | 1 | - |
| Week 52: Pubic hair development (for male) | 1 | - |
| Week 52: Pubic hair development (for male) | 0 | - |
| Week 0: Penis development (for male) | 5 | - |
| Week 0: Penis development (for male) | 0 | - |
| Week 0: Penis development (for male) | 0 | - |
| Week 0: Penis development (for male) | 0 | - |
| Week 0: Penis development (for male) | 0 | - |
| Week 52: Penis development (for male) | 2 | - |
| Week 52: Penis development (for male) | 1 | - |
| Week 52: Penis development (for male) | 0 | - |
| Week 52: Penis development (for male) | 0 | - |
| Week 52: Penis development (for male) | 0 | - |
| Part A+B: LiraglutideWeek 0: Breast development (for female) | 11 | - |
| Week 0: Breast development (for female) | 1 | - |
| Week 0: Breast development (for female) | 8 | - |
| Week 0: Breast development (for female) | 0 | - |
| Week 0: Breast development (for female) | 2 | - |
| Week 52: Breast development (for female) | 2 | - |
| Week 52: Breast development (for female) | 4 | - |
| Week 52: Breast development (for female) | 7 | - |
| Week 52: Breast development (for female) | 1 | - |
| Week 52: Breast development (for female) | 3 | - |
| Week 0: Pubic hair development (for female) | 7 | - |
| Week 0: Pubic hair development (for female) | 5 | - |
| Week 0: Pubic hair development (for female) | 3 | - |
| Week 0: Pubic hair development (for female) | 5 | - |
| Week 0: Pubic hair development (for female) | 2 | - |
| Week 52: Pubic hair development (for female) | 2 | - |
| Week 52: Pubic hair development (for female) | 3 | - |
| Week 52: Pubic hair development (for female) | 6 | - |
| Week 52: Pubic hair development (for female) | 4 | - |
| Week 52: Pubic hair development (for female) | 2 | - |
| Week 0: Pubic hair development (for male) | 6 | - |
| Week 0: Pubic hair development (for male) | 3 | - |
| Week 0: Pubic hair development (for male) | 2 | - |
| Week 0: Pubic hair development (for male) | 2 | - |
| Week 0: Pubic hair development (for male) | 2 | - |
| Week 52: Pubic hair development (for male) | 4 | - |
| Week 52: Pubic hair development (for male) | 1 | - |
| Week 52: Pubic hair development (for male) | 3 | - |
| Week 52: Pubic hair development (for male) | 3 | - |
| Week 52: Pubic hair development (for male) | 3 | - |
| Week 0: Penis development (for male) | 6 | - |
| Week 0: Penis development (for male) | 4 | - |
| Week 0: Penis development (for male) | 1 | - |
| Week 0: Penis development (for male) | 3 | - |
| Week 0: Penis development (for male) | 1 | - |
| Week 52: Penis development (for male) | 3 | - |
| Week 52: Penis development (for male) | 3 | - |
| Week 52: Penis development (for male) | 2 | - |
| Week 52: Penis development (for male) | 3 | - |
| Week 52: Penis development (for male) | 3 | - |
| Part A+B: PlaceboWeek 0: Breast development (for female) | 2 | - |
| Week 0: Breast development (for female) | 0 | - |
| Week 0: Breast development (for female) | 2 | - |
| Week 0: Breast development (for female) | 1 | - |
| Week 0: Breast development (for female) | 2 | - |
| Week 52: Breast development (for female) | 1 | - |
| Week 52: Breast development (for female) | 0 | - |
| Week 52: Breast development (for female) | 1 | - |
| Week 52: Breast development (for female) | 2 | - |
| Week 52: Breast development (for female) | 2 | - |
| Week 0: Pubic hair development (for female) | 1 | - |
| Week 0: Pubic hair development (for female) | 0 | - |
| Week 0: Pubic hair development (for female) | 3 | - |
| Week 0: Pubic hair development (for female) | 1 | - |
| Week 0: Pubic hair development (for female) | 2 | - |
| Week 52: Pubic hair development (for female) | 0 | - |
| Week 52: Pubic hair development (for female) | 0 | - |
| Week 52: Pubic hair development (for female) | 2 | - |
| Week 52: Pubic hair development (for female) | 2 | - |
| Week 52: Pubic hair development (for female) | 2 | - |
| Week 0: Pubic hair development (for male) | 3 | - |
| Week 0: Pubic hair development (for male) | 1 | - |
| Week 0: Pubic hair development (for male) | 5 | - |
| Week 0: Pubic hair development (for male) | 2 | - |
| Week 0: Pubic hair development (for male) | 1 | - |
| Week 52: Pubic hair development (for male) | 0 | - |
| Week 52: Pubic hair development (for male) | 1 | - |
| Week 52: Pubic hair development (for male) | 3 | - |
| Week 52: Pubic hair development (for male) | 4 | - |
| Week 52: Pubic hair development (for male) | 1 | - |
| Week 0: Penis development (for male) | 6 | - |
| Week 0: Penis development (for male) | 3 | - |
| Week 0: Penis development (for male) | 1 | - |
| Week 0: Penis development (for male) | 2 | - |
| Week 0: Penis development (for male) | 0 | - |
| Week 52: Penis development (for male) | 3 | - |
| Week 52: Penis development (for male) | 2 | - |
| Week 52: Penis development (for male) | 1 | - |
| Week 52: Penis development (for male) | 2 | - |
| Week 52: Penis development (for male) | 1 | - |
Height Velocity at Week 16
Time frame:Week 16
change from baseline, descriptive
Posted result
| Group | Mean · Centimeters/year (cm/yr) | 95% CI |
|---|---|---|
| Part A: Liraglutide | 2.113 | - |
| Part A: Placebo | 2.718 | - |
| Part B: Liraglutide | 4.190 | - |
| Part B: Placebo | 6.898 | - |
| Part A+B: Liraglutide | 3.090 | - |
| Part A+B: Placebo | 4.258 | - |
Height Velocity at Week 52
Time frame:week 52
change from baseline, descriptive
Posted result
| Group | Mean · Centimeters/year (cm/yr) | 95% CI |
|---|---|---|
| Part A: Liraglutide | 1.564 | - |
| Part A: Placebo | 1.839 | - |
| Part B: Liraglutide | 4.752 | - |
| Part B: Placebo | 5.620 | - |
| Part A+B: Liraglutide | 3.004 | - |
| Part A+B: Placebo | 3.173 | - |
Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 16
Time frame:Week 0, week 16
Androgen, change
change from baseline, improvement
Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 52
Time frame:Week 0, week 52
Androgen, change
change from baseline, improvement
Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, descriptive
Change in Hormone Level: Estradiol (Females) From Baseline at Week 52
Time frame:Week 0, week 52
Androgen, change
change from baseline, improvement
Change in Hormone Level: Testosterone (Males) From Baseline at Week 16
Time frame:Week 0, week 16
Androgen, change
change from baseline, improvement
Change in Hormone Level: Testosterone (Males) From Baseline at Week 52
Time frame:Week 0, week 52
Androgen, change
change from baseline, improvement
Number of Participants With Change in Pubertal Status From Baseline at Week 16
Time frame:Week 0, week 16
categorical status, descriptive
Number of Participants With Change in Pubertal Status From Baseline at Week 52
Time frame:Week 0, week 52
categorical status, descriptive
Height Velocity at Week 16
Time frame:Week 16
change from baseline, descriptive
Height Velocity at Week 52
Time frame:week 52
change from baseline, descriptive
Other (unclassified)
7 endpointsChange in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, descriptive
Change in Biochemistry: Albumin From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
Change in Biochemistry: Albumin From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, descriptive
Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
componentsigf 1 change, cortisol change
Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 52
Time frame:Week 0, week 52
change from baseline, descriptive
componentsigf 1 change, cortisol change
Change in Hormone Level: Estradiol (Females) From Baseline at Week 16
Time frame:Week 0, week 16
change from baseline, descriptive
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- The Journal of clinical endocrinology and metabolism2022 Dec 17PMID36181471doi:10.1210/clinem/dgac549via CT.gov reference
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.