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Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.
This Trial is Conducted Globally. The Aim of This Trial is to Investigate Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis
Lead sponsor
Asset
Semaglutide
Subcutaneous · GLP-1 agonist
Listed sites
158
Recruiting sites
—
Enrollment
320
actual
Study population
MASH / NAFLD / liver fibrosis, Obesity / overweight
Key I/E criterion
—
Primary endpoint
•MASH resolution, no fibrosis worsening
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Eligibility criteria
Endpoints (176)
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
10 endpointsPercentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 72 Weeks (Yes/No)
Time frame:Week 72
≥5% weight-loss responders
threshold achievement, improvement
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgYes | 43.8 | — |
| No | 51.3 | — |
| Missing | 5.0 | — |
| Semaglutide 0.2 mgYes | 62.8 | — |
| No | 28.2 | — |
| Missing | 9.0 | — |
| Semaglutide 0.4 mgYes | 76.8 | — |
| No | 17.1 | — |
| Missing | 6.1 | — |
| PlaceboYes | 16.3 | — |
| No | 78.8 | — |
| Missing | 5.0 | — |
Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 72 Weeks (Yes/No)
Time frame:Week 72
≥10% weight-loss responders
threshold achievement, improvement
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgYes | 17.5 | — |
| No | 77.5 | — |
| Missing | 5.0 | — |
| Semaglutide 0.2 mgYes | 38.5 | — |
| No | 52.6 | — |
| Missing | 9.0 | — |
| Semaglutide 0.4 mgYes | 59.8 | — |
| No | 34.1 | — |
| Missing | 6.1 | — |
| PlaceboYes | 2.5 | — |
| No | 92.5 | — |
| Missing | 5.0 | — |
Change in Body Weight
Time frame:Baseline (week 0), Week 72
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), Kilograms | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | -4.8 | — |
| Semaglutide 0.2 mg | -9.4 | — |
| Semaglutide 0.4 mg | -12.3 | — |
| Placebo | -1.0 | — |
Change in Waist Circumference
Time frame:Baseline (week 0), Week 72
Waist circumference, change
change from baseline, improvement
Posted result
| Group | Value (mean), Centimeters | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | -3.9 | — |
| Semaglutide 0.2 mg | -7.1 | — |
| Semaglutide 0.4 mg | -11.4 | — |
| Placebo | -1.7 | — |
Change in Body Mass Index (BMI)
Time frame:Baseline (week 0), Week 72
BMI, change
change from baseline, improvement
Posted result
| Group | Value (mean), Kilograms per square meter | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | -1.8 | — |
| Semaglutide 0.2 mg | -3.5 | — |
| Semaglutide 0.4 mg | -4.6 | — |
| Placebo | -0.3 | — |
Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 72 Weeks (Yes/No)
Time frame:Week 72
≥5% weight-loss responders
threshold achievement, improvement
Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 72 Weeks (Yes/No)
Time frame:Week 72
≥10% weight-loss responders
threshold achievement, improvement
Change in Body Weight
Time frame:Baseline (week 0), Week 72
Body weight, absolute change (kg)
change from baseline, improvement
Change in Waist Circumference
Time frame:Baseline (week 0), Week 72
Waist circumference, change
change from baseline, improvement
Change in Body Mass Index (BMI)
Time frame:Baseline (week 0), Week 72
BMI, change
change from baseline, improvement
Glycemic / diabetes
10 endpointsChange in Glycosylated Haemoglobin (HbA1c) (%-Point)
Time frame:Baseline (week 0), Week 72
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), Percentage point of HbA1c | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | -0.7 | — |
| Semaglutide 0.2 mg | -1.2 | — |
| Semaglutide 0.4 mg | -1.2 | — |
| Placebo | -0.0 | — |
Change in HbA1c (Millimoles Per Mole)
Time frame:Baseline (week 0), Week 72
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), millimoles per mole | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | -7.9 | — |
| Semaglutide 0.2 mg | -12.8 | — |
| Semaglutide 0.4 mg | -12.8 | — |
| Placebo | -0.3 | — |
Change in Fasting Plasma Glucose (FPG)
Time frame:Baseline (week 0), Week 72
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (mean), Millimoles per liter | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | -1.39 | — |
| Semaglutide 0.2 mg | -2.17 | — |
| Semaglutide 0.4 mg | -2.09 | — |
| Placebo | -0.34 | — |
Change in Fasting Glucagon
Time frame:Baseline (week 0), Week 72
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of glucagon | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.78 | — |
| Semaglutide 0.2 mg | 0.65 | — |
| Semaglutide 0.4 mg | 0.63 | — |
| Placebo | 1.04 | — |
Change in Homeostatic Model Assessment - Insulin Resistance (HOMA-IR)
Time frame:Baseline (week 0), Week 72
HOMA-IR (insulin sensitivity)
percent change from baseline, improvement
Posted result
| Group | Value (geometric_mean), Ratio of HOMA-IR | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.77 | — |
| Semaglutide 0.2 mg | 0.60 | — |
| Semaglutide 0.4 mg | 0.58 | — |
| Placebo | 0.81 | — |
Change in Glycosylated Haemoglobin (HbA1c) (%-Point)
Time frame:Baseline (week 0), Week 72
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in HbA1c (Millimoles Per Mole)
Time frame:Baseline (week 0), Week 72
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in Fasting Plasma Glucose (FPG)
Time frame:Baseline (week 0), Week 72
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change in Fasting Glucagon
Time frame:Baseline (week 0), Week 72
ratio, improvement
Change in Homeostatic Model Assessment - Insulin Resistance (HOMA-IR)
Time frame:Baseline (week 0), Week 72
HOMA-IR (insulin sensitivity)
ratio, improvement
MASH / liver
51 endpointsPercentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No)
Time frame:After 72 weeks
MASH resolution, no fibrosis worsening
categorical status, improvement
SNOMED 442685003
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgYes | 40.4 | — |
| No | 54.4 | — |
| Missing | 5.3 | — |
| Semaglutide 0.2 mgYes | 35.6 | — |
| No | 47.5 | — |
| Missing | 16.9 | — |
| Semaglutide 0.4 mgYes | 58.9 | — |
| No | 30.4 | — |
| Missing | 10.7 | — |
| PlaceboYes | 17.2 | — |
| No | 74.1 | — |
| Missing | 8.6 | — |
Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No)
Time frame:After 72 weeks
MASH resolution, no fibrosis worsening
categorical status, improvement
SNOMED 442685003
Percentage of Participants With at Least One Stage of Liver Fibrosis Improvement With no Worsening of NASH After 72 Weeks (Yes/No)
Time frame:After 72 weeks
Fibrosis ≥1-stage improvement, no MASH worsening
categorical status, improvement
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgYes | 49.1 | — |
| No | 45.6 | — |
| Missing | 5.3 | — |
| Semaglutide 0.2 mgYes | 32.2 | — |
| No | 50.8 | — |
| Missing | 16.9 | — |
| Semaglutide 0.4 mgYes | 42.9 | — |
| No | 46.4 | — |
| Missing | 10.7 | — |
| PlaceboYes | 32.8 | — |
| No | 58.6 | — |
| Missing | 8.6 | — |
Percentage of Participants With Change in Total NAFLD (Non- Alcoholic Fatty Liver Disease) Activity Score (NAS)
Time frame:Baseline (week 0), Week 72
categorical status, improvement
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgImprovement | 71.3 | — |
| Worsening | 7.5 | — |
| No change | 13.8 | — |
| Missing | 7.5 | — |
| Semaglutide 0.2 mgImprovement | 79.5 | — |
| Worsening | 2.6 | — |
| No change | 5.1 | — |
| Missing | 12.8 | — |
| Semaglutide 0.4 mgImprovement | 82.9 | — |
| Worsening | 3.7 | — |
| No change | 1.2 | — |
| Missing | 12.2 | — |
| PlaceboImprovement | 43.8 | — |
| Worsening | 16.3 | — |
| No change | 27.5 | — |
| Missing | 12.5 | — |
Percentage of Participants With Change in Steatosis
Time frame:Baseline (week 0), Week 72
categorical status, improvement
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgImprovement | 52.5 | — |
| Worsening | 6.3 | — |
| No change | 33.8 | — |
| Missing | 7.5 | — |
| Semaglutide 0.2 mgImprovement | 60.3 | — |
| Worsening | 2.6 | — |
| No change | 24.4 | — |
| Missing | 12.8 | — |
| Semaglutide 0.4 mgImprovement | 63.4 | — |
| Worsening | 3.7 | — |
| No change | 20.7 | — |
| Missing | 12.2 | — |
| PlaceboImprovement | 26.3 | — |
| Worsening | 15.0 | — |
| No change | 46.3 | — |
| Missing | 12.5 | — |
Percentage of Participants With Change in Lobular Inflammation
Time frame:Baseline (week 0), Week 72
categorical status, improvement
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgImprovement | 41.3 | — |
| Worsening | 7.5 | — |
| No change | 43.8 | — |
| Missing | 7.5 | — |
| Semaglutide 0.2 mgImprovement | 47.4 | — |
| Worsening | 7.7 | — |
| No change | 32.1 | — |
| Missing | 12.8 | — |
| Semaglutide 0.4 mgImprovement | 37.8 | — |
| Worsening | 6.1 | — |
| No change | 43.9 | — |
| Missing | 12.2 | — |
| PlaceboImprovement | 26.3 | — |
| Worsening | 17.5 | — |
| No change | 45.0 | — |
| Missing | 11.3 | — |
Percentage of Participants With Change in Hepatocyte Ballooning
Time frame:Baseline (week 0), Week 72
categorical status, improvement
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgImprovement | 61.3 | — |
| Worsening | 2.5 | — |
| No change | 28.8 | — |
| Missing | 7.5 | — |
| Semaglutide 0.2 mgImprovement | 70.5 | — |
| Worsening | 2.6 | — |
| No change | 14.1 | — |
| Missing | 12.8 | — |
| Semaglutide 0.4 mgImprovement | 74.4 | — |
| Worsening | 1.2 | — |
| No change | 12.2 | — |
| Missing | 12.2 | — |
| PlaceboImprovement | 38.8 | — |
| Worsening | 2.5 | — |
| No change | 46.3 | — |
| Missing | 12.5 | — |
Percentage of Participants With Change in Fibrosis Stage According to the Kleiner Fibrosis Classification
Time frame:Baseline (week 0), Week 72
categorical status, improvement
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgImprovement | 46.3 | — |
| Worsening | 10.0 | — |
| No change | 36.3 | — |
| Missing | 7.5 | — |
| Semaglutide 0.2 mgImprovement | 32.1 | — |
| Worsening | 7.7 | — |
| No change | 42.3 | — |
| Missing | 17.9 | — |
| Semaglutide 0.4 mgImprovement | 42.7 | — |
| Worsening | 4.9 | — |
| No change | 36.6 | — |
| Missing | 15.9 | — |
| PlaceboImprovement | 31.3 | — |
| Worsening | 18.8 | — |
| No change | 37.5 | — |
| Missing | 12.5 | — |
Percentage of Participants With Change in Activity Component of Steatosis-activity-fibrosis (SAF) Score
Time frame:Baseline (week 0), Week 72
categorical status, improvement
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgImprovement | 62.5 | — |
| Worsening | 7.5 | — |
| No change | 22.5 | — |
| Missing | 7.5 | — |
| Semaglutide 0.2 mgImprovement | 71.8 | — |
| Worsening | 3.8 | — |
| No change | 11.5 | — |
| Missing | 12.8 | — |
| Semaglutide 0.4 mgImprovement | 72.0 | — |
| Worsening | 1.2 | — |
| No change | 14.6 | — |
| Missing | 12.2 | — |
| PlaceboImprovement | 42.5 | — |
| Worsening | 11.3 | — |
| No change | 33.8 | — |
| Missing | 12.5 | — |
Change in Fibrosis-4 Score
Time frame:Baseline (week 0), Week 72
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of fibrosis-4 score | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.81 | — |
| Semaglutide 0.2 mg | 0.77 | — |
| Semaglutide 0.4 mg | 0.77 | — |
| Placebo | 0.95 | — |
Change in NAFLD Fibrosis Score (NFS)
Time frame:Baseline (week 0), Week 72
change from baseline, improvement
Posted result
| Group | Value (mean), Score on a scale | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | -0.322 | — |
| Semaglutide 0.2 mg | -0.617 | — |
| Semaglutide 0.4 mg | -0.475 | — |
| Placebo | -0.040 | — |
Change in Alanine Aminotransferase (ALT)
Time frame:Baseline (week 0), Week 72
ALT, change
ratio, improvement
LOINC 1742-6
Posted result
| Group | Value (geometric_mean), Ratio of ALT | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.62 | — |
| Semaglutide 0.2 mg | 0.57 | — |
| Semaglutide 0.4 mg | 0.40 | — |
| Placebo | 0.80 | — |
Change in Aspartate Aminotransferase (AST)
Time frame:Baseline (week 0), Week 72
AST, change
ratio, improvement
LOINC 1920-8
Posted result
| Group | Value (geometric_mean), Ratio of AST | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.66 | — |
| Semaglutide 0.2 mg | 0.63 | — |
| Semaglutide 0.4 mg | 0.50 | — |
| Placebo | 0.84 | — |
Change in Gamma Glutamyl Transferase (GGT)
Time frame:Baseline (week 0), Week 72
γ-GT, change
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of GGT | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.76 | — |
| Semaglutide 0.2 mg | 0.64 | — |
| Semaglutide 0.4 mg | 0.48 | — |
| Placebo | 0.92 | — |
Change in Albumin
Time frame:Baseline (week 0), Week 72
albumin change from baseline
change from baseline, improvement
LOINC 1751-7
Posted result
| Group | Value (geometric_mean), Ratio of albumin | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 1.02 | — |
| Semaglutide 0.2 mg | 1.01 | — |
| Semaglutide 0.4 mg | 1.01 | — |
| Placebo | 1.02 | — |
Change in International Normalized Ratio (INR)
Time frame:Baseline (week 0), Week 72
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of INR | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.97 | — |
| Semaglutide 0.2 mg | 0.96 | — |
| Semaglutide 0.4 mg | 0.93 | — |
| Placebo | 0.99 | — |
Change in Enhanced Liver Fibrosis (ELF)
Time frame:Baseline (week 0), Week 72
ELF score, change
change from baseline, improvement
Posted result
| Group | Value (mean), score on a scale | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | -0.4 | — |
| Semaglutide 0.2 mg | -0.4 | — |
| Semaglutide 0.4 mg | -0.6 | — |
| Placebo | 0.1 | — |
Change in Cytokeratin 18 (CK-18) Fragments
Time frame:Baseline (week 0), Week 72
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of CK-18 fragments | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgM30 | 0.52 | — |
| M65 | 0.51 | — |
| Semaglutide 0.2 mgM30 | 0.50 | — |
| M65 | 0.52 | — |
| Semaglutide 0.4 mgM30 | 0.40 | — |
| M65 | 0.38 | — |
| PlaceboM30 | 0.78 | — |
| M65 | 0.71 | — |
Change in microRNA 122 (miR-122)
Time frame:Baseline (week 0), Week 72
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of miR-122 | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.86 | — |
| Semaglutide 0.2 mg | 0.74 | — |
| Semaglutide 0.4 mg | 0.58 | — |
| Placebo | 1.28 | — |
Change in Interleukin-1 Receptor (IL-1R) Antagonist
Time frame:Baseline (week 0), Week 72
change from baseline, improvement
Posted result
| Group | Value (geometric_mean), Ratio of IL-1R antagonist | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.87 | — |
| Semaglutide 0.2 mg | 0.85 | — |
| Semaglutide 0.4 mg | 0.73 | — |
| Placebo | 0.94 | — |
Change in Monocyte Chemoattractant Protein 1 (MCP-1)
Time frame:Baseline (week 0), Week 72
MCP-1 / CCL2
change from baseline, improvement
Posted result
| Group | Value (geometric_mean), Ratio of MCP-1 | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 1.07 | — |
| Semaglutide 0.2 mg | 1.08 | — |
| Semaglutide 0.4 mg | 0.99 | — |
| Placebo | 1.04 | — |
Change in Fibroblast Growth Factor 21 (FGF-21)
Time frame:Baseline (week 0), Week 72
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of FGF-21 | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.72 | — |
| Semaglutide 0.2 mg | 0.61 | — |
| Semaglutide 0.4 mg | 0.55 | — |
| Placebo | 0.76 | — |
Change in Liver Stiffness Assessed by FibroScan®
Time frame:Baseline (week 0), Week 72
Liver stiffness (VCTE), change
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of liver stiffness | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.72 | — |
| Semaglutide 0.2 mg | 0.64 | — |
| Semaglutide 0.4 mg | 0.66 | — |
| Placebo | 1.18 | — |
Change in Liver Steatosis Assessed by FibroScan®
Time frame:Baseline (week 0), Week 72
change from baseline, improvement
Posted result
| Group | Value (mean), Decibels per meter | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | -5.8 | — |
| Semaglutide 0.2 mg | -50.9 | — |
| Semaglutide 0.4 mg | -42.1 | — |
| Placebo | -18.7 | — |
Change in Total Bilirubin (mg/dL)
Time frame:Baseline (week 0), Week 72
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of total bilirubin | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.978 | — |
| Semaglutide 0.2 mg | 1.011 | — |
| Semaglutide 0.4 mg | 0.949 | — |
| Placebo | 1.040 | — |
Change in Total Bilirubin (Umol/L)
Time frame:Baseline (week 0), Week 72
ratio, descriptive
Posted result
| Group | Value (geometric_mean), Ratio of total bilirubin | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.978 | — |
| Semaglutide 0.2 mg | 1.011 | — |
| Semaglutide 0.4 mg | 0.949 | — |
| Placebo | 1.040 | — |
Change in Alkaline Phosphatase
Time frame:Baseline (week 0), Week 72
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of alkaline phosphatase | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.980 | — |
| Semaglutide 0.2 mg | 0.931 | — |
| Semaglutide 0.4 mg | 0.884 | — |
| Placebo | 0.992 | — |
Change in Ferritin
Time frame:Baseline (week 0), Week 72
ferritin
change from baseline, improvement
Posted result
| Group | Value (geometric_mean), Ratio of ferritin | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.660 | — |
| Semaglutide 0.2 mg | 0.617 | — |
| Semaglutide 0.4 mg | 0.603 | — |
| Placebo | 0.713 | — |
Percentage of Participants With at Least One Stage of Liver Fibrosis Improvement With no Worsening of NASH After 72 Weeks (Yes/No)
Time frame:After 72 weeks
Fibrosis ≥1-stage improvement, no MASH worsening
categorical status, improvement
Percentage of Participants With Change in Total NAFLD (Non- Alcoholic Fatty Liver Disease) Activity Score (NAS)
Time frame:Baseline (week 0), Week 72
categorical status, improvement
Percentage of Participants With Change in Steatosis
Time frame:Baseline (week 0), Week 72
categorical status, improvement
Percentage of Participants With Change in Lobular Inflammation
Time frame:Baseline (week 0), Week 72
categorical status, improvement
Percentage of Participants With Change in Hepatocyte Ballooning
Time frame:Baseline (week 0), Week 72
categorical status, improvement
Percentage of Participants With Change in Fibrosis Stage According to the Kleiner Fibrosis Classification
Time frame:Baseline (week 0), Week 72
categorical status, improvement
Percentage of Participants With Change in Activity Component of Steatosis-activity-fibrosis (SAF) Score
Time frame:Baseline (week 0), Week 72
categorical status, improvement
Change in Fibrosis-4 Score
Time frame:Baseline (week 0), Week 72
ratio, improvement
Change in NAFLD Fibrosis Score (NFS)
Time frame:Baseline (week 0), Week 72
change from baseline, improvement
Change in Alanine Aminotransferase (ALT)
Time frame:Baseline (week 0), Week 72
ALT, change
ratio, improvement
LOINC 1742-6
Change in Aspartate Aminotransferase (AST)
Time frame:Baseline (week 0), Week 72
AST, change
ratio, improvement
LOINC 1920-8
Change in Gamma Glutamyl Transferase (GGT)
Time frame:Baseline (week 0), Week 72
γ-GT, change
ratio, improvement
Change in International Normalized Ratio (INR)
Time frame:Baseline (week 0), Week 72
ratio, improvement
Change in Enhanced Liver Fibrosis (ELF)
Time frame:Baseline (week 0), Week 72
ELF score, change
change from baseline, improvement
Change in Cytokeratin 18 (CK-18) Fragments
Time frame:Baseline (week 0), Week 72
ratio, improvement
Change in microRNA 122 (miR-122)
Time frame:Baseline (week 0), Week 72
ratio, improvement
Change in Fibroblast Growth Factor 21 (FGF-21)
Time frame:Baseline (week 0), Week 72
ratio, improvement
Change in Liver Stiffness Assessed by FibroScan®
Time frame:Baseline (week 0), Week 72
Liver stiffness (VCTE), change
ratio, improvement
Change in Liver Steatosis Assessed by FibroScan®
Time frame:Baseline (week 0), Week 72
change from baseline, improvement
Change in Total Bilirubin (mg/dL)
Time frame:Baseline (week 0), Week 72
ratio, improvement
Change in Total Bilirubin (Umol/L)
Time frame:Baseline (week 0), Week 72
ratio, improvement
Change in Alkaline Phosphatase
Time frame:Baseline (week 0), Week 72
ratio, improvement
Change in Ferritin
Time frame:Baseline (week 0), Week 72
ratio, improvement
Renal / kidney
7 endpointsChange in Creatinine (mg/dL)
Time frame:Baseline (week 0), Week 72
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of creatinine | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 1.018 | — |
| Semaglutide 0.2 mg | 1.069 | — |
| Semaglutide 0.4 mg | 1.026 | — |
| Placebo | 1.021 | — |
Change in Creatinine (Umol/L)
Time frame:Baseline (week 0), Week 72
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of creatinine | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 1.018 | — |
| Semaglutide 0.2 mg | 1.069 | — |
| Semaglutide 0.4 mg | 1.026 | — |
| Placebo | 1.021 | — |
Change in Estimated Glomerular Filtration Rate (eGFR)
Time frame:Baseline (week 0), Week 72
eGFR, change
ratio, improvement
LOINC 98979-8
Posted result
| Group | Value (geometric_mean), Ratio of eGFR | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.976 | — |
| Semaglutide 0.2 mg | 0.940 | — |
| Semaglutide 0.4 mg | 0.973 | — |
| Placebo | 0.969 | — |
Change in Albumin
Time frame:Baseline (week 0), Week 72
ratio, improvement
Change in Creatinine (mg/dL)
Time frame:Baseline (week 0), Week 72
ratio, improvement
LOINC 2160-0
Change in Creatinine (Umol/L)
Time frame:Baseline (week 0), Week 72
ratio, improvement
Change in Estimated Glomerular Filtration Rate (eGFR)
Time frame:Baseline (week 0), Week 72
eGFR, change
ratio, improvement
LOINC 98979-8
Cardiometabolic biomarkers
21 endpointsChange in Diastolic Blood Pressure (DBP)
Time frame:Baseline (week 0), Week 72
Diastolic BP, change
change from baseline, improvement
LOINC 8462-4
Posted result
| Group | Value (mean), Millimeters of mercury | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0 | — |
| Semaglutide 0.2 mg | -2 | — |
| Semaglutide 0.4 mg | -2 | — |
| Placebo | -1 | — |
Change in Systolic Blood Pressure (SBP)
Time frame:Baseline (week 0), Week 72
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Posted result
| Group | Value (mean), Millimeters of mercury | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | -2 | — |
| Semaglutide 0.2 mg | -7 | — |
| Semaglutide 0.4 mg | -6 | — |
| Placebo | -2 | — |
Change in Total Cholesterol
Time frame:Baseline (week 0), Week 72
Total cholesterol, change
ratio, improvement
LOINC 2093-3
Posted result
| Group | Value (geometric_mean), Ratio of total cholesterol | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.98 | — |
| Semaglutide 0.2 mg | 1.00 | — |
| Semaglutide 0.4 mg | 0.93 | — |
| Placebo | 0.93 | — |
Change in Low Density Lipoprotein (LDL) Cholesterol
Time frame:Baseline (week 0), Week 72
LDL-C, change
ratio, improvement
LOINC 13457-7
Posted result
| Group | Value (geometric_mean), Ratio of LDL cholesterol | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.96 | — |
| Semaglutide 0.2 mg | 1.01 | — |
| Semaglutide 0.4 mg | 0.92 | — |
| Placebo | 0.90 | — |
Change in High Density Lipoprotein (HDL) Cholesterol
Time frame:Baseline (week 0), Week 72
HDL-C, change
ratio, improvement
LOINC 2085-9
Posted result
| Group | Value (geometric_mean), Ratio of HDL cholesterol | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 1.04 | — |
| Semaglutide 0.2 mg | 1.05 | — |
| Semaglutide 0.4 mg | 1.09 | — |
| Placebo | 1.01 | — |
Change in Very Low Density Lipoprotein (VLDL) Cholesterol
Time frame:Baseline (week 0), Week 72
VLDL, change
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of VLDL cholesterol | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.89 | — |
| Semaglutide 0.2 mg | 0.90 | — |
| Semaglutide 0.4 mg | 0.74 | — |
| Placebo | 0.93 | — |
Change in Triglycerides
Time frame:Baseline (week 0), Week 72
Triglycerides, change
ratio, improvement
LOINC 2571-8
Posted result
| Group | Value (geometric_mean), Ratio of triglycerides | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.88 | — |
| Semaglutide 0.2 mg | 0.89 | — |
| Semaglutide 0.4 mg | 0.73 | — |
| Placebo | 0.95 | — |
Change in Free Fatty Acids
Time frame:Baseline (week 0), Week 72
Free fatty acids, change
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of free fatty acids | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.83 | — |
| Semaglutide 0.2 mg | 0.92 | — |
| Semaglutide 0.4 mg | 0.72 | — |
| Placebo | 1.05 | — |
Change in High Sensitivity C-reactive Protein (hsCRP)
Time frame:Baseline (week 0), Week 72
hs-CRP, change
ratio, improvement
LOINC 30522-7
Posted result
| Group | Value (geometric_mean), Ratio of hsCRP | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.78 | — |
| Semaglutide 0.2 mg | 0.50 | — |
| Semaglutide 0.4 mg | 0.41 | — |
| Placebo | 0.91 | — |
Change in Pulse From Baseline to Week 72
Time frame:Baseline (week 0), Week 72
Heart rate, change
change from baseline, improvement
Posted result
| Group | Value (mean), beats per minute (bpm) | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 2.2 | — |
| Semaglutide 0.2 mg | 2.1 | — |
| Semaglutide 0.4 mg | 0.9 | — |
| Placebo | -0.3 | — |
Change in Monocyte Chemoattractant Protein 1 (MCP-1)
Time frame:Baseline (week 0), Week 72
ratio, improvement
Change in Diastolic Blood Pressure (DBP)
Time frame:Baseline (week 0), Week 72
Diastolic BP, change
change from baseline, improvement
LOINC 8462-4
Change in Systolic Blood Pressure (SBP)
Time frame:Baseline (week 0), Week 72
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Change in Total Cholesterol
Time frame:Baseline (week 0), Week 72
Total cholesterol, change
ratio, improvement
LOINC 2093-3
Change in Low Density Lipoprotein (LDL) Cholesterol
Time frame:Baseline (week 0), Week 72
LDL-C, change
ratio, improvement
LOINC 13457-7
Change in High Density Lipoprotein (HDL) Cholesterol
Time frame:Baseline (week 0), Week 72
HDL-C, change
ratio, improvement
LOINC 2085-9
Change in Very Low Density Lipoprotein (VLDL) Cholesterol
Time frame:Baseline (week 0), Week 72
VLDL, change
ratio, improvement
Change in Triglycerides
Time frame:Baseline (week 0), Week 72
Triglycerides, change
ratio, improvement
LOINC 2571-8
Change in Free Fatty Acids
Time frame:Baseline (week 0), Week 72
Free fatty acids, change
ratio, improvement
Change in High Sensitivity C-reactive Protein (hsCRP)
Time frame:Baseline (week 0), Week 72
hs-CRP, change
ratio, improvement
LOINC 30522-7
Change in Pulse From Baseline to Week 72
Time frame:Baseline (week 0), Week 72
Heart rate, change
change from baseline, improvement
Patient-reported / QoL
2 endpointsChange in Short Form 36 (SF-36) Score
Time frame:Baseline (week 0), Week 72
SF-36 total
change from baseline, improvement
Posted result
| Group | Value (mean), Scores on a scale | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgMental component sum | 2.2 | — |
| Physical component sum | 2.1 | — |
| Physical functioning | 1.8 | — |
| Role functioning | 2.1 | — |
| Bodily pain | 1.3 | — |
| General health | 7.2 | — |
| Vitality | 2.3 | — |
| Social functioning | 3.7 | — |
| Role emotional | 2.2 | — |
| Mental health | 1.2 | — |
| Semaglutide 0.2 mgMental component sum | 0.6 | — |
| Physical component sum | 1.1 | — |
| Physical functioning | 2.0 | — |
| Role functioning | 0.5 | — |
| Bodily pain | 1.2 | — |
| General health | 2.3 | — |
| Vitality | 0.6 | — |
| Social functioning | -0.1 | — |
| Role emotional | 0.6 | — |
| Mental health | 1.5 | — |
| Semaglutide 0.4 mgMental component sum | 1.2 | — |
| Physical component sum | 3.9 | — |
| Physical functioning | 2.8 | — |
| Role functioning | 2.2 | — |
| Bodily pain | 3.4 | — |
| General health | 9.0 | — |
| Vitality | 4.6 | — |
| Social functioning | 2.2 | — |
| Role emotional | 0.5 | — |
| Mental health | 1.3 | — |
| PlaceboMental component sum | -0.4 | — |
| Physical component sum | -0.1 | — |
| Physical functioning | -0.4 | — |
| Role functioning | -0.3 | — |
| Bodily pain | -1.3 | — |
| General health | 4.3 | — |
| Vitality | -0.2 | — |
| Social functioning | -1.6 | — |
| Role emotional | -0.3 | — |
| Mental health | -0.2 | — |
Change in Short Form 36 (SF-36) Score
Time frame:Baseline (week 0), Week 72
SF-36 total
change from baseline, improvement
Safety / tolerability / PK
66 endpointsNumber of Treatment-emergent Adverse Events (TEAEs)
Time frame:From week 0 to week 79
Treatment-emergent AEs (any)
event count, descriptive
Posted result
| Group | Value (number), events | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 525 | — |
| Semaglutide 0.2 mg | 577 | — |
| Semaglutide 0.4 mg | 511 | — |
| Placebo | 445 | — |
Number of Treatment-emergent Hypoglycaemic Episodes
Time frame:From week 0 to week 79
Documented hypoglycemia
event count, event
Posted result
| Group | Value (number), episodes | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 54 | — |
| Semaglutide 0.2 mg | 30 | — |
| Semaglutide 0.4 mg | 66 | — |
| Placebo | 18 | — |
Number of Treatment-emergent Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemic Episodes
Time frame:From week 0 to week 79
Documented hypoglycemia
event count, event
componentsSevere hypoglycemia, Documented hypoglycemia
Posted result
| Group | Value (number), episodes | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 3 | — |
| Semaglutide 0.2 mg | 5 | — |
| Semaglutide 0.4 mg | 17 | — |
| Placebo | 2 | — |
Number of Treatment-emergent Severe Hypoglycaemic Episodes
Time frame:From week 0 to week 79
Severe hypoglycemia
event count, event
Posted result
| Group | Value (number), episodes | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 2 | — |
| Semaglutide 0.2 mg | 2 | — |
| Semaglutide 0.4 mg | 0 | — |
| Placebo | 0 | — |
Number of Participants Discontinuing Treatment Due to Gastrointestinal Adverse Events
Time frame:From week 0 to week 79
Discontinuation due to AE
event count, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 1 | — |
| Semaglutide 0.2 mg | 6 | — |
| Semaglutide 0.4 mg | 2 | — |
| Placebo | 0 | — |
Number of Participants With Occurrence of Anti-semaglutide Antibodies During and After 72 Weeks Treatment (Yes/No)
Time frame:From week 0 to week 79
Immunogenicity (ADA)
threshold achievement, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgYes | 4 | — |
| No | 76 | — |
| Semaglutide 0.2 mgYes | 1 | — |
| No | 77 | — |
| Semaglutide 0.4 mgYes | 2 | — |
| No | 79 | — |
Number of Participants With Anti-semaglutide Antibodies With in Vitro Neutralising Effect During and After 72 Weeks Treatment (Yes/No)
Time frame:From week 0 to week 79
Immunogenicity (ADA)
threshold achievement, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgYes | 0 | — |
| No | 80 | — |
| Semaglutide 0.2 mgYes | 0 | — |
| No | 78 | — |
| Semaglutide 0.4 mgYes | 0 | — |
| No | 81 | — |
Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 During and After 72 Weeks Treatment (Yes/No)
Time frame:From week 0 to week 79
Immunogenicity (ADA)
threshold achievement, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgYes | 4 | — |
| No | 76 | — |
| Semaglutide 0.2 mgYes | 0 | — |
| No | 78 | — |
| Semaglutide 0.4 mgYes | 2 | — |
| No | 79 | — |
Number of Participants With Cross-reacting Anti-semaglutide Binding Antibodies With in Vitro Neutralising Effect to Native GLP-1 During and After 72 Weeks Treatment (Yes/No)
Time frame:From week 0 to week 79
Immunogenicity (ADA)
categorical status, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgYes | 0 | — |
| No | 80 | — |
| Semaglutide 0.2 mgYes | 0 | — |
| No | 78 | — |
| Semaglutide 0.4 mgYes | 0 | — |
| No | 81 | — |
Percentage of Participants With Change in Electrocardiogram (ECG)
Time frame:Baseline (week 0), Week 72
categorical status, descriptive
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgWeek 0: Normal | 58.8 | — |
| Week 0: Abnormal NCS | 41.3 | — |
| Week 0: Abnormal CS | 0.0 | — |
| Week 72: Normal | 64.9 | — |
| Week 72: Abnormal NCS | 35.1 | — |
| Week 72: Abnormal CS | 0.0 | — |
| Semaglutide 0.2 mgWeek 0: Normal | 60.3 | — |
| Week 0: Abnormal NCS | 39.7 | — |
| Week 0: Abnormal CS | 0.0 | — |
| Week 72: Normal | 65.1 | — |
| Week 72: Abnormal NCS | 34.9 | — |
| Week 72: Abnormal CS | 0.0 | — |
| Semaglutide 0.4 mgWeek 0: Normal | 66.7 | — |
| Week 0: Abnormal NCS | 32.1 | — |
| Week 0: Abnormal CS | 1.2 | — |
| Week 72: Normal | 74.6 | — |
| Week 72: Abnormal NCS | 23.9 | — |
| Week 72: Abnormal CS | 1.4 | — |
| PlaceboWeek 0: Normal | 63.8 | — |
| Week 0: Abnormal NCS | 36.3 | — |
| Week 0: Abnormal CS | 0.0 | — |
| Week 72: Normal | 60.0 | — |
| Week 72: Abnormal NCS | 38.6 | — |
| Week 72: Abnormal CS | 1.4 | — |
Percentage of Participants With Change in Physical Examination: Cardiovascular System
Time frame:Week -6, week 72
threshold achievement, event
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgWeek -6: Normal | 87.5 | — |
| Week -6: Abnormal NCS | 11.3 | — |
| Week -6: Abnormal CS | 1.3 | — |
| Week 72: Normal | 87.8 | — |
| Week 72: Abnormal NCS | 12.2 | — |
| Week 72: Abnormal CS | 0.0 | — |
| Semaglutide 0.2 mgWeek -6: Normal | 93.6 | — |
| Week -6: Abnormal NCS | 5.1 | — |
| Week -6: Abnormal CS | 1.3 | — |
| Week 72: Normal | 96.9 | — |
| Week 72: Abnormal NCS | 3.1 | — |
| Week 72: Abnormal CS | 0.0 | — |
| Semaglutide 0.4 mgWeek -6: Normal | 92.6 | — |
| Week -6: Abnormal NCS | 7.4 | — |
| Week -6: Abnormal CS | 0.0 | — |
| Week 72: Normal | 94.4 | — |
| Week 72: Abnormal NCS | 5.6 | — |
| Week 72: Abnormal CS | 0.0 | — |
| PlaceboWeek -6: Normal | 92.5 | — |
| Week -6: Abnormal NCS | 6.3 | — |
| Week -6: Abnormal CS | 1.3 | — |
| Week 72: Normal | 90.1 | — |
| Week 72: Abnormal NCS | 8.5 | — |
| Week 72: Abnormal CS | 1.4 | — |
Percentage of Participants With Change in Physical Examination: Central and Peripheral Nervous System
Time frame:Week -6, week 72
threshold achievement, descriptive
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgWeek -6: Normal | 92.5 | — |
| Week -6: Abnormal NCS | 5.0 | — |
| Week -6: Abnormal CS | 2.5 | — |
| Week 72: Normal | 94.6 | — |
| Week 72: Abnormal NCS | 5.4 | — |
| Week 72: Abnormal CS | 0.0 | — |
| Semaglutide 0.2 mgWeek -6: Normal | 94.8 | — |
| Week -6: Abnormal NCS | 5.2 | — |
| Week -6: Abnormal CS | 0.0 | — |
| Week 72: Normal | 93.7 | — |
| Week 72: Abnormal NCS | 4.8 | — |
| Week 72: Abnormal CS | 1.6 | — |
| Semaglutide 0.4 mgWeek -6: Normal | 98.7 | — |
| Week -6: Abnormal NCS | 1.3 | — |
| Week -6: Abnormal CS | 0.0 | — |
| Week 72: Normal | 98.6 | — |
| Week 72: Abnormal NCS | 1.4 | — |
| Week 72: Abnormal CS | 0.0 | — |
| PlaceboWeek -6: Normal | 95.0 | — |
| Week -6: Abnormal NCS | 3.8 | — |
| Week -6: Abnormal CS | 1.3 | — |
| Week 72: Normal | 92.9 | — |
| Week 72: Abnormal NCS | 7.1 | — |
| Week 72: Abnormal CS | 0.0 | — |
Percentage of Participants With Change in Physical Examination: Gastrointestinal System Including Mouth
Time frame:Week -6, week 72
descriptive
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgWeek -6: Normal | 82.5 | — |
| Week -6: Abnormal NCS | 13.8 | — |
| Week -6: Abnormal CS | 3.8 | — |
| Week 72: Normal | 89.2 | — |
| Week 72: Abnormal NCS | 10.8 | — |
| Week 72: Abnormal CS | 0.0 | — |
| Semaglutide 0.2 mgWeek -6: Normal | 83.1 | — |
| Week -6: Abnormal NCS | 15.6 | — |
| Week -6: Abnormal CS | 1.3 | — |
| Week 72: Normal | 81.0 | — |
| Week 72: Abnormal NCS | 19.0 | — |
| Week 72: Abnormal CS | 0.0 | — |
| Semaglutide 0.4 mgWeek -6: Normal | 84.0 | — |
| Week -6: Abnormal NCS | 16.0 | — |
| Week -6: Abnormal CS | 0.0 | — |
| Week 72: Normal | 87.5 | — |
| Week 72: Abnormal NCS | 12.5 | — |
| Week 72: Abnormal CS | 0.0 | — |
| PlaceboWeek -6: Normal | 86.3 | — |
| Week -6: Abnormal NCS | 12.5 | — |
| Week -6: Abnormal CS | 1.3 | — |
| Week 72: Normal | 84.5 | — |
| Week 72: Abnormal NCS | 14.1 | — |
| Week 72: Abnormal CS | 1.4 | — |
Percentage of Participants With Change in Physical Examination: General Appearance
Time frame:Week -6, week 72
threshold achievement, descriptive
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgWeek -6: Normal | 83.8 | — |
| Week -6: Abnormal NCS | 16.3 | — |
| Week -6: Abnormal CS | 0.0 | — |
| Week 72: Normal | 83.8 | — |
| Week 72: Abnormal NCS | 16.2 | — |
| Week 72: Abnormal CS | 0.0 | — |
| Semaglutide 0.2 mgWeek -6: Normal | 85.9 | — |
| Week -6: Abnormal NCS | 12.8 | — |
| Week -6: Abnormal CS | 1.3 | — |
| Week 72: Normal | 90.6 | — |
| Week 72: Abnormal NCS | 6.3 | — |
| Week 72: Abnormal CS | 3.1 | — |
| Semaglutide 0.4 mgWeek -6: Normal | 79.0 | — |
| Week -6: Abnormal NCS | 21.0 | — |
| Week -6: Abnormal CS | 0.0 | — |
| Week 72: Normal | 90.3 | — |
| Week 72: Abnormal NCS | 9.7 | — |
| Week 72: Abnormal CS | 0.0 | — |
| PlaceboWeek -6: Normal | 80.0 | — |
| Week -6: Abnormal NCS | 20.0 | — |
| Week -6: Abnormal CS | 0.0 | — |
| Week 72: Normal | 76.1 | — |
| Week 72: Abnormal NCS | 23.9 | — |
| Week 72: Abnormal CS | 0.0 | — |
Percentage of Participants With Change in Physical Examination: Head, Ears, Eyes, Nose, Throat, Neck
Time frame:Week -6, week 72
threshold achievement, event
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgWeek -6: Normal | 97.5 | — |
| Week -6: Abnormal NCS | 2.5 | — |
| Week -6: Abnormal CS | 0.0 | — |
| Week 72: Normal | 94.5 | — |
| Week 72: Abnormal NCS | 4.1 | — |
| Week 72: Abnormal CS | 1.4 | — |
| Semaglutide 0.2 mgWeek -6: Normal | 94.8 | — |
| Week -6: Abnormal NCS | 5.2 | — |
| Week -6: Abnormal CS | 0.0 | — |
| Week 72: Normal | 96.8 | — |
| Week 72: Abnormal NCS | 3.2 | — |
| Week 72: Abnormal CS | 0.0 | — |
| Semaglutide 0.4 mgWeek -6: Normal | 98.8 | — |
| Week -6: Abnormal NCS | 1.3 | — |
| Week -6: Abnormal CS | 0.0 | — |
| Week 72: Normal | 98.6 | — |
| Week 72: Abnormal NCS | 1.4 | — |
| Week 72: Abnormal CS | 0.0 | — |
| PlaceboWeek -6: Normal | 97.5 | — |
| Week -6: Abnormal NCS | 2.5 | — |
| Week -6: Abnormal CS | 0.0 | — |
| Week 72: Normal | 98.6 | — |
| Week 72: Abnormal NCS | 0.0 | — |
| Week 72: Abnormal CS | 1.4 | — |
Percentage of Participants With Change in Physical Examination: Lymph Node Palpation
Time frame:Week -6, week 72
threshold achievement, descriptive
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgWeek -6: Normal | 100.0 | — |
| Week -6: Abnormal NCS | 0.0 | — |
| Week -6: Abnormal CS | 0.0 | — |
| Week 72: Normal | 100.0 | — |
| Week 72: Abnormal NCS | 0.0 | — |
| Week 72: Abnormal CS | 0.0 | — |
| Semaglutide 0.2 mgWeek -6: Normal | 98.7 | — |
| Week -6: Abnormal NCS | 1.3 | — |
| Week -6: Abnormal CS | 0.0 | — |
| Week 72: Normal | 100.0 | — |
| Week 72: Abnormal NCS | 0.0 | — |
| Week 72: Abnormal CS | 0.0 | — |
| Semaglutide 0.4 mgWeek -6: Normal | 100.0 | — |
| Week -6: Abnormal NCS | 0.0 | — |
| Week -6: Abnormal CS | 0.0 | — |
| Week 72: Normal | 100.0 | — |
| Week 72: Abnormal NCS | 0.0 | — |
| Week 72: Abnormal CS | 0.0 | — |
| PlaceboWeek -6: Normal | 100.0 | — |
| Week -6: Abnormal NCS | 0.0 | — |
| Week -6: Abnormal CS | 0.0 | — |
| Week 72: Normal | 100.0 | — |
| Week 72: Abnormal NCS | 0.0 | — |
| Week 72: Abnormal CS | 0.0 | — |
Percentage of Participants With Change in Physical Examination: Musculoskeletal System
Time frame:Week -6, week 72
threshold achievement, event
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgWeek -6: Normal | 95.0 | — |
| Week -6: Abnormal NCS | 3.8 | — |
| Week -6: Abnormal CS | 1.3 | — |
| Week 72: Normal | 94.6 | — |
| Week 72: Abnormal NCS | 5.4 | — |
| Week 72: Abnormal CS | 0.0 | — |
| Semaglutide 0.2 mgWeek -6: Normal | 96.1 | — |
| Week -6: Abnormal NCS | 3.9 | — |
| Week -6: Abnormal CS | 0.0 | — |
| Week 72: Normal | 96.8 | — |
| Week 72: Abnormal NCS | 3.2 | — |
| Week 72: Abnormal CS | 0.0 | — |
| Semaglutide 0.4 mgWeek -6: Normal | 94.9 | — |
| Week -6: Abnormal NCS | 5.1 | — |
| Week -6: Abnormal CS | 0.0 | — |
| Week 72: Normal | 100.0 | — |
| Week 72: Abnormal NCS | 0.0 | — |
| Week 72: Abnormal CS | 0.0 | — |
| PlaceboWeek -6: Normal | 95.0 | — |
| Week -6: Abnormal NCS | 3.8 | — |
| Week -6: Abnormal CS | 1.3 | — |
| Week 72: Normal | 95.8 | — |
| Week 72: Abnormal NCS | 4.2 | — |
| Week 72: Abnormal CS | 0.0 | — |
Percentage of Participants With Change in Physical Examination: Respiratory System
Time frame:Week -6, week 72
threshold achievement, descriptive
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgWeek -6: Normal | 100.0 | — |
| Week -6: Abnormal NCS | 0.0 | — |
| Week -6: Abnormal CS | 0.0 | — |
| Week 72: Normal | 98.6 | — |
| Week 72: Abnormal NCS | 0.0 | — |
| Week 72: Abnormal CS | 1.4 | — |
| Semaglutide 0.2 mgWeek -6: Normal | 100.0 | — |
| Week -6: Abnormal NCS | 0.0 | — |
| Week -6: Abnormal CS | 0.0 | — |
| Week 72: Normal | 96.9 | — |
| Week 72: Abnormal NCS | 3.1 | — |
| Week 72: Abnormal CS | 0.0 | — |
| Semaglutide 0.4 mgWeek -6: Normal | 100.0 | — |
| Week -6: Abnormal NCS | 0.0 | — |
| Week -6: Abnormal CS | 0.0 | — |
| Week 72: Normal | 98.6 | — |
| Week 72: Abnormal NCS | 1.4 | — |
| Week 72: Abnormal CS | 0.0 | — |
| PlaceboWeek -6: Normal | 97.5 | — |
| Week -6: Abnormal NCS | 2.5 | — |
| Week -6: Abnormal CS | 0.0 | — |
| Week 72: Normal | 98.6 | — |
| Week 72: Abnormal NCS | 1.4 | — |
| Week 72: Abnormal CS | 0.0 | — |
Percentage of Participants With Change in Physical Examination: Skin
Time frame:Week -6, week 72
threshold achievement, event
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgWeek -6: Normal | 96.3 | — |
| Week -6: Abnormal NCS | 2.5 | — |
| Week -6: Abnormal CS | 1.3 | — |
| Week 72: Normal | 94.6 | — |
| Week 72: Abnormal NCS | 4.1 | — |
| Week 72: Abnormal CS | 1.4 | — |
| Semaglutide 0.2 mgWeek -6: Normal | 92.3 | — |
| Week -6: Abnormal NCS | 6.4 | — |
| Week -6: Abnormal CS | 1.3 | — |
| Week 72: Normal | 87.5 | — |
| Week 72: Abnormal NCS | 10.9 | — |
| Week 72: Abnormal CS | 1.6 | — |
| Semaglutide 0.4 mgWeek -6: Normal | 85.2 | — |
| Week -6: Abnormal NCS | 13.6 | — |
| Week -6: Abnormal CS | 1.2 | — |
| Week 72: Normal | 90.0 | — |
| Week 72: Abnormal NCS | 8.6 | — |
| Week 72: Abnormal CS | 1.4 | — |
| PlaceboWeek -6: Normal | 90.0 | — |
| Week -6: Abnormal NCS | 10.0 | — |
| Week -6: Abnormal CS | 0.0 | — |
| Week 72: Normal | 88.7 | — |
| Week 72: Abnormal NCS | 11.3 | — |
| Week 72: Abnormal CS | 0.0 | — |
Percentage of Participants With Change in Physical Examination: Thyroid Gland
Time frame:Week -6, week 72
Thyroid event
threshold achievement, event
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 0.1 mgWeek -6: Normal | 88.8 | — |
| Week -6: Abnormal NCS | 10.0 | — |
| Week -6: Abnormal CS | 1.3 | — |
| Week 72: Normal | 94.6 | — |
| Week 72: Abnormal NCS | 5.4 | — |
| Week 72: Abnormal CS | 0.0 | — |
| Semaglutide 0.2 mgWeek -6: Normal | 97.4 | — |
| Week -6: Abnormal NCS | 2.6 | — |
| Week -6: Abnormal CS | 0.0 | — |
| Week 72: Normal | 98.4 | — |
| Week 72: Abnormal NCS | 1.6 | — |
| Week 72: Abnormal CS | 0.0 | — |
| Semaglutide 0.4 mgWeek -6: Normal | 97.5 | — |
| Week -6: Abnormal NCS | 2.5 | — |
| Week -6: Abnormal CS | 0.0 | — |
| Week 72: Normal | 97.1 | — |
| Week 72: Abnormal NCS | 2.9 | — |
| Week 72: Abnormal CS | 0.0 | — |
| PlaceboWeek -6: Normal | 98.8 | — |
| Week -6: Abnormal NCS | 0.0 | — |
| Week -6: Abnormal CS | 1.3 | — |
| Week 72: Normal | 98.6 | — |
| Week 72: Abnormal NCS | 1.4 | — |
| Week 72: Abnormal CS | 0.0 | — |
Change in Haematocrit
Time frame:Baseline (week 0), Week 72
haematocrit
change from baseline, descriptive
LOINC 20570-8
Posted result
| Group | Value (mean), Percentage of haematocrit in blood | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | -0.79 | — |
| Semaglutide 0.2 mg | -0.71 | — |
| Semaglutide 0.4 mg | -1.43 | — |
| Placebo | -0.41 | — |
Change in Haemoglobin (g/dL)
Time frame:Baseline (week 0), Week 72
change from baseline, descriptive
Posted result
| Group | Value (mean), Grams per deciliter (g/dL) | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.18 | — |
| Semaglutide 0.2 mg | 0.08 | — |
| Semaglutide 0.4 mg | -0.07 | — |
| Placebo | 0.21 | — |
Change in Haemoglobin (mmol/L)
Time frame:Baseline (week 0), Week 72
change from baseline, descriptive
Posted result
| Group | Value (mean), millimoles per liter (mmol/L) | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.11 | — |
| Semaglutide 0.2 mg | 0.05 | — |
| Semaglutide 0.4 mg | -0.05 | — |
| Placebo | 0.13 | — |
Change in Leukocytes
Time frame:Baseline (week 0), Week 72
change from baseline, descriptive
Posted result
| Group | Value (mean), 10^9 cells per liter (10^9/L) | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.489 | — |
| Semaglutide 0.2 mg | 0.260 | — |
| Semaglutide 0.4 mg | -0.047 | — |
| Placebo | 0.075 | — |
Change in Thrombocytes
Time frame:Baseline (week 0), Week 72
change from baseline, descriptive
Posted result
| Group | Value (mean), 10^9 cells per liter (10^9/L) | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 8.8 | — |
| Semaglutide 0.2 mg | 14.6 | — |
| Semaglutide 0.4 mg | 9.0 | — |
| Placebo | 0.3 | — |
Change in Erythrocytes
Time frame:Baseline (week 0), Week 72
change from baseline, descriptive
Posted result
| Group | Value (mean), 10^12 cells per liter (10^12/L) | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.038 | — |
| Semaglutide 0.2 mg | 0.004 | — |
| Semaglutide 0.4 mg | -0.034 | — |
| Placebo | 0.054 | — |
Change in Creatine Kinase
Time frame:Baseline (week 0), Week 72
ratio, descriptive
Posted result
| Group | Value (geometric_mean), Ratio of creatine kinase | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.975 | — |
| Semaglutide 0.2 mg | 0.798 | — |
| Semaglutide 0.4 mg | 0.825 | — |
| Placebo | 0.904 | — |
Change in Urea
Time frame:Baseline (week 0), Week 72
urea
change from baseline, descriptive
Posted result
| Group | Value (geometric_mean), Ratio of urea | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 1.018 | — |
| Semaglutide 0.2 mg | 0.973 | — |
| Semaglutide 0.4 mg | 1.042 | — |
| Placebo | 1.043 | — |
Change in Sodium (mEq/L)
Time frame:Baseline (week 0), Week 72
serum sodium
change from baseline, descriptive
LOINC 2951-2
Posted result
| Group | Value (geometric_mean), Ratio of sodium | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.999 | — |
| Semaglutide 0.2 mg | 1.000 | — |
| Semaglutide 0.4 mg | 1.002 | — |
| Placebo | 1.002 | — |
Change in Sodium (mmol/L)
Time frame:Baseline (week 0), Week 72
sodium serum
change from baseline, descriptive
LOINC 2951-2
Posted result
| Group | Value (geometric_mean), Ratio of sodium | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 0.999 | — |
| Semaglutide 0.2 mg | 1.000 | — |
| Semaglutide 0.4 mg | 1.002 | — |
| Placebo | 1.002 | — |
Change in Potassium (mEq/L)
Time frame:Baseline (week 0), Week 72
ratio, descriptive
Posted result
| Group | Value (geometric_mean), Ratio of potassium | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 1.004 | — |
| Semaglutide 0.2 mg | 0.979 | — |
| Semaglutide 0.4 mg | 0.998 | — |
| Placebo | 0.998 | — |
Change in Potassium (mmol/L)
Time frame:Baseline (week 0), Week 72
ratio, descriptive
Posted result
| Group | Value (geometric_mean), Ratio of potassium | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 1.004 | — |
| Semaglutide 0.2 mg | 0.979 | — |
| Semaglutide 0.4 mg | 0.998 | — |
| Placebo | 0.998 | — |
Change in Calcium (mg/dL)
Time frame:Baseline (week 0), Week 72
ratio, descriptive
Posted result
| Group | Value (geometric_mean), Ratio of calcium | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 1.017 | — |
| Semaglutide 0.2 mg | 1.018 | — |
| Semaglutide 0.4 mg | 1.008 | — |
| Placebo | 1.010 | — |
Change in Calcium (mmol/L)
Time frame:Baseline (week 0), Week 72
ratio, descriptive
Posted result
| Group | Value (geometric_mean), Ratio of calcium | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 1.017 | — |
| Semaglutide 0.2 mg | 1.018 | — |
| Semaglutide 0.4 mg | 1.008 | — |
| Placebo | 1.010 | — |
Change in Amylase
Time frame:Baseline (week 0), Week 72
ratio, descriptive
Posted result
| Group | Value (geometric_mean), Ratio of amylase | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 1.155 | — |
| Semaglutide 0.2 mg | 1.120 | — |
| Semaglutide 0.4 mg | 1.170 | — |
| Placebo | 1.051 | — |
Change in Lipase
Time frame:Baseline (week 0), Week 72
ratio, descriptive
Posted result
| Group | Value (geometric_mean), Ratio of lipase | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 1.305 | — |
| Semaglutide 0.2 mg | 1.245 | — |
| Semaglutide 0.4 mg | 1.375 | — |
| Placebo | 1.003 | — |
Change in Calcitonin
Time frame:Baseline (week 0), Week 72
Thyroid event
ratio, descriptive
Posted result
| Group | Value (geometric_mean), Ratio of Calcitonin | 95% CI |
|---|---|---|
| Semaglutide 0.1 mg | 1.040 | — |
| Semaglutide 0.2 mg | 0.937 | — |
| Semaglutide 0.4 mg | 1.000 | — |
| Placebo | 0.950 | — |
Number of Treatment-emergent Adverse Events (TEAEs)
Time frame:From week 0 to week 79
Treatment-emergent AEs (any)
event count, event
Number of Treatment-emergent Hypoglycaemic Episodes
Time frame:From week 0 to week 79
Documented hypoglycemia
event count, event
Number of Treatment-emergent Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemic Episodes
Time frame:From week 0 to week 79
Documented hypoglycemia
event count, event
componentsSevere hypoglycemia, Documented hypoglycemia
Number of Treatment-emergent Severe Hypoglycaemic Episodes
Time frame:From week 0 to week 79
Severe hypoglycemia
event count, event
Number of Participants Discontinuing Treatment Due to Gastrointestinal Adverse Events
Time frame:From week 0 to week 79
Discontinuation due to AE
event count, event
Number of Participants With Occurrence of Anti-semaglutide Antibodies During and After 72 Weeks Treatment (Yes/No)
Time frame:From week 0 to week 79
Immunogenicity (ADA)
categorical status, event
Number of Participants With Anti-semaglutide Antibodies With in Vitro Neutralising Effect During and After 72 Weeks Treatment (Yes/No)
Time frame:From week 0 to week 79
Immunogenicity (ADA)
categorical status, event
Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 During and After 72 Weeks Treatment (Yes/No)
Time frame:From week 0 to week 79
Immunogenicity (ADA)
categorical status, event
Number of Participants With Cross-reacting Anti-semaglutide Binding Antibodies With in Vitro Neutralising Effect to Native GLP-1 During and After 72 Weeks Treatment (Yes/No)
Time frame:From week 0 to week 79
Immunogenicity (ADA)
categorical status, event
Percentage of Participants With Change in Electrocardiogram (ECG)
Time frame:Baseline (week 0), Week 72
descriptive
Percentage of Participants With Change in Physical Examination: Cardiovascular System
Time frame:Week -6, week 72
descriptive
Percentage of Participants With Change in Physical Examination: Central and Peripheral Nervous System
Time frame:Week -6, week 72
threshold achievement, descriptive
Percentage of Participants With Change in Physical Examination: Gastrointestinal System Including Mouth
Time frame:Week -6, week 72
threshold achievement, descriptive
Percentage of Participants With Change in Physical Examination: General Appearance
Time frame:Week -6, week 72
threshold achievement, descriptive
Percentage of Participants With Change in Physical Examination: Head, Ears, Eyes, Nose, Throat, Neck
Time frame:Week -6, week 72
descriptive
Percentage of Participants With Change in Physical Examination: Lymph Node Palpation
Time frame:Week -6, week 72
threshold achievement, descriptive
Percentage of Participants With Change in Physical Examination: Musculoskeletal System
Time frame:Week -6, week 72
threshold achievement, descriptive
Percentage of Participants With Change in Physical Examination: Respiratory System
Time frame:Week -6, week 72
threshold achievement, descriptive
Percentage of Participants With Change in Physical Examination: Skin
Time frame:Week -6, week 72
threshold achievement, event
Percentage of Participants With Change in Physical Examination: Thyroid Gland
Time frame:Week -6, week 72
threshold achievement, event
Change in Haematocrit
Time frame:Baseline (week 0), Week 72
change from baseline, descriptive
Change in Erythrocytes
Time frame:Baseline (week 0), Week 72
change from baseline, descriptive
Change in Creatine Kinase
Time frame:Baseline (week 0), Week 72
ratio, descriptive
Change in Potassium (mmol/L)
Time frame:Baseline (week 0), Week 72
ratio, descriptive
Change in Calcium (mg/dL)
Time frame:Baseline (week 0), Week 72
ratio, descriptive
Change in Calcium (mmol/L)
Time frame:Baseline (week 0), Week 72
ratio, descriptive
Change in Amylase
Time frame:Baseline (week 0), Week 72
ratio, descriptive
Change in Lipase
Time frame:Baseline (week 0), Week 72
ratio, descriptive
Change in Calcitonin
Time frame:Baseline (week 0), Week 72
Thyroid event
ratio, descriptive
Other (unclassified)
9 endpointsChange in Interleukin-1 Receptor (IL-1R) Antagonist
Time frame:Baseline (week 0), Week 72
ratio, improvement
Change in Haemoglobin (g/dL)
Time frame:Baseline (week 0), Week 72
change from baseline, descriptive
Change in Haemoglobin (mmol/L)
Time frame:Baseline (week 0), Week 72
change from baseline, descriptive
Change in Leukocytes
Time frame:Baseline (week 0), Week 72
change from baseline, descriptive
Change in Thrombocytes
Time frame:Baseline (week 0), Week 72
change from baseline, descriptive
Change in Urea
Time frame:Baseline (week 0), Week 72
ratio, descriptive
Change in Sodium (mEq/L)
Time frame:Baseline (week 0), Week 72
ratio, descriptive
Change in Sodium (mmol/L)
Time frame:Baseline (week 0), Week 72
ratio, descriptive
Change in Potassium (mEq/L)
Time frame:Baseline (week 0), Week 72
ratio, descriptive
Publications (8)
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
- Alimentary pharmacology & therapeutics2026 Feb (month)PMID40985232doi:10.1111/apt.70376via clinicaltrials gov reference derived + pubmed nct search
- JHEP reports : innovation in hepatology2025 Oct (month)PMID40980163doi:10.1016/j.jhepr.2025.101521via clinicaltrials gov reference derived + pubmed nct search
- Diabetes, obesity & metabolism2025 Feb (month)PMID39609879doi:10.1111/dom.16065via pubmed nct search
- Hepatology (Baltimore, Md.)2024 Jul 1PMID38112484doi:10.1097/HEP.0000000000000723via clinicaltrials gov reference derived + pubmed nct search
- EClinicalMedicine2023 Dec (month)PMID38058795doi:10.1016/j.eclinm.2023.102310via clinicaltrials gov reference derived + pubmed nct search
- Alimentary pharmacology & therapeutics2023 Aug (month)PMID37328931doi:10.1111/apt.17598via clinicaltrials gov reference derived + pubmed nct search
- The New England journal of medicine2021 Mar 25PMID33185364doi:10.1056/NEJMoa2028395via CT.gov reference + pubmed nct search
- Contemporary clinical trials2020 Oct (month)PMID33039693doi:10.1016/j.cct.2020.106174via clinicaltrials gov reference derived + pubmed nct search
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 1, 2026 snapshot.