GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity

Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity. 56-week, Double-blind, Randomised, Parallel-group, Placebo-controlled Multi-national Trial Followed by a 26-week Period Off Study-drug

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

251

actual

Study population

Obesity / overweight

Key I/E criteria

•BMI ≥30•Age 12-17

Primary endpoint

•BMI SDS, change

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

NCT IDNCT02918279

Org study IDNN8022-4180

Secondary ID2014-004353-14

Secondary IDU1111-1162-7101WHO

Timeline

Milestones

Study first posted2016-09-28estimated

Study start2016-09-29actual

Primary completion2019-02-14actual

Study completion2019-08-08actual

Last update posted2020-04-27actual

Results first posted2020-04-27actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age12 Years

Maximum age17 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial

•Male or female, age 12 to less than 18 years at the time of signing informed consent and less than 18 years at date of randomisation

•BMI corresponding to equal to or above 30 kg/m^2 for adults by international cut-off points and equal or above the 95th percentile for age and sex (for diagnosis of obesity)

•Stable body weight during the previous 90 days before screening V2 (below 5 kg self-reported weight change)

•History of failing to lose sufficient weight with lifestyle modification as judged by the investigator and documented in subject's medical record

Exclusion criteria

•Pre-pubertal subjects (Tanner stage 1) at screening V2

•Type 1 diabetes mellitus (T1DM)

•Family or personal history of multiple endocrine neoplasia type 2 (MEN2)

•Medullary thyroid carcinoma (MTC)

•History of pancreatitis (acute or chronic)

•Subjects with secondary causes of obesity (i.e., hypothalamic, genetic or endocrine causes)

•Treatment with medications within 90 days before screening V2 that, based on the investigator's judgement, may cause significant weight change. This should also include treatment with any of the following medications: pramlintide, orlistat, zonisamide, topiramate, lorcaserin, phenteremine, bupropion, naltrexone, glucagon-like peptide-1 (GLP-1) receptor agonists, or metformin (used as treatment for obesity)

•Anti-diabetic treatment other than metformin

•History of major depressive disorder within 2 years before screening V2

Endpoints (122)

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

Safety / tolerability / PK

Weight & body composition

Cardiometabolic biomarkers

Other clinical outcomes

Glycemic / diabetes

Other (unclassified)

Patient-reported / QoL

Renal / kidney

Weight & body composition

24 endpoints

Primary/registry result

Change in BMI SDS (Week 0, Week 56)

Time frame:Week 0, week 56

BMI SDS, change

change from baseline, improvement

Posted result

Group	Value (mean), SDS score	95% CI
Liraglutide 3.0 mg	-0.25	—
Placebo	-0.02	—

Treatment difference-0.2295% CI-0.37 – -0.08p0.0022ANCOVA

Primary/protocol endpoint

Change in BMI SDS (Week 0, Week 56)

Time frame:Week 0, week 56

BMI SDS, change

change from baseline, improvement

Secondary/registry result

Percent of Subjects Achieving ≥5% Reduction in Baseline BMI

Time frame:Weeks 30, 56 and 82

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Liraglutide 3.0 mgWeek 30 (Yes)	46.2	—
Week 30 (No)	53.8	—
Week 56 (Yes)	45.1	—
Week 56 (No)	54.9	—
Week 82 (Yes)	29.5	—
Week 82 (No)	70.5	—
PlaceboWeek 30 (Yes)	14.7	—
Week 30 (No)	85.3	—
Week 56 (Yes)	19.0	—
Week 56 (No)	81.0	—
Week 82 (Yes)	18.6	—
Week 82 (No)	81.4	—

Secondary/registry result

Percent of Subjects Achieving ≥10% Reduction in Baseline BMI

Time frame:Weeks 30, 56 and 82

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Liraglutide 3.0 mgWeek 30 (Yes)	24.4	—
Week 30 (No)	75.6	—
Week 56 (Yes)	29.2	—
Week 56 (No)	70.8	—
Week 82 (Yes)	18.8	—
Week 82 (No)	81.3	—
PlaceboWeek 30 (Yes)	5.2	—
Week 30 (No)	94.8	—
Week 56 (Yes)	8.6	—
Week 56 (No)	91.4	—
Week 82 (Yes)	10.8	—
Week 82 (No)	89.2	—

Secondary/registry result

Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82))

Time frame:(Week 0, week 30); (Week 0, week 82); (Week 56, week 82)

BMI SDS, change

change from baseline, improvement

Posted result

Group	Value (mean), SDS score	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	-0.26	—
Change from week 0 to week 82	-0.06	—
Change from week 56 to week 82	0.22	—
PlaceboChange from week 0 to week 30	-0.04	—
Change from week 0 to week 82	0.07	—
Change from week 56 to week 82	0.08	—

Secondary/registry result

Change in BMI

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), kg/m^2	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	-1.8	—
Change from week 0 to week 56	-1.6	—
Change from week 56 to week 82	1.5	—
PlaceboChange from week 0 to week 30	-0.2	—
Change from week 0 to week 56	0.1	—
Change from week 56 to week 82	0.7	—

Secondary/registry result

Change in Body Weight (kg)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	-3.9	—
Change from week 0 to week 56	-2.7	—
Change from week 56 to week 82	4.7	—
PlaceboChange from week 0 to week 30	0.4	—
Change from week 0 to week 56	2.1	—
Change from week 56 to week 82	2.4	—

Secondary/registry result

Change in Body Weight (%)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage change	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	-4.3	—
Change from week 0 to week 56	-3.2	—
Change from week 56 to week 82	5.3	—
PlaceboChange from week 0 to week 30	0.4	—
Change from week 0 to week 56	2.2	—
Change from week 56 to week 82	2.3	—

Secondary/registry result

Change in Body Weight (lb)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/registry result

Change in Waist Circumference

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), cm	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	-4.63	—
Change from week 0 to week 56	-5.12	—
Change from week 56 to week 82	3.58	—
PlaceboChange from week 0 to week 30	-2.01	—
Change from week 0 to week 56	-1.51	—
Change from week 56 to week 82	1.24	—

Secondary/registry result

Change in Waist-to-hip Circumference Ratio

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, improvement

Posted result

Group	Value (mean), Ratio	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	-0.015	—
Change from week 0 to week 56	-0.022	—
Change from week 56 to week 82	0.010	—
PlaceboChange from week 0 to week 30	-0.018	—
Change from week 0 to week 56	-0.023	—
Change from week 56 to week 82	0.003	—

Secondary/registry result

Change in BMI SDS (%)

Time frame:(Week 0, week 30); (Week 0, week 56)

BMI SDS, change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percentage change	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	-8.73	—
Change from week 0 to week 56	-8.32	—
PlaceboChange from week 0 to week 30	-1.70	—
Change from week 0 to week 56	-0.68	—

Secondary/registry result

Change in Height SDS

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, descriptive

Posted result

Group	Value (mean), SDS	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	0.11	—
Change from week 0 to week 56	0.20	—
Change from week 56 to week 82	0.07	—
PlaceboChange from week 0 to week 30	0.13	—
Change from week 0 to week 56	0.24	—
Change from week 56 to week 82	0.06	—

Secondary/protocol endpoint

Percent of Subjects Achieving ≥5% Reduction in Baseline BMI

Time frame:Weeks 30, 56 and 82

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percent of Subjects Achieving ≥10% Reduction in Baseline BMI

Time frame:Weeks 30, 56 and 82

BMI, change

threshold achievement, improvement

Secondary/protocol endpoint

Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82))

Time frame:(Week 0, week 30); (Week 0, week 82); (Week 56, week 82)

BMI SDS, change

change from baseline, improvement

Secondary/protocol endpoint

Change in BMI

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight (kg)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight (%)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight (lb)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist-to-hip Circumference Ratio

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, improvement

Secondary/protocol endpoint

Change in BMI SDS (%)

Time frame:(Week 0, week 30); (Week 0, week 56)

BMI SDS, change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Height SDS

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, improvement

Glycemic / diabetes

14 endpoints

Secondary/registry result

Change in HbA1c

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	-0.1	—
Change from week 0 to week 56	-0.1	—
Change from week 56 to week 82	0.1	—
PlaceboChange from week 0 to week 30	-0.0	—
Change from week 0 to week 56	-0.0	—
Change from week 56 to week 82	0.1	—

Secondary/registry result

Change in FPG

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	-0.2	—
Change from week 0 to week 56	-0.1	—
Change from week 56 to week 82	0.1	—
PlaceboChange from week 0 to week 30	-0.0	—
Change from week 0 to week 56	-0.0	—
Change from week 56 to week 82	0.1	—

Secondary/registry result

Change in Fasting Insulin (Ratio to Baseline)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of fasting insulin	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	1.13	—
Change from week 0 to week 56	1.06	—
Change from week 56 to week 82	1.00	—
PlaceboChange from week 0 to week 30	1.14	—
Change from week 0 to week 56	1.10	—
Change from week 56 to week 82	1.08	—

Secondary/registry result

Change in Fasting C-peptide (Ratio to Baseline)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

C-peptide AUC

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of fasting C-peptide	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	1.12	—
Change from week 0 to week 56	0.98	—
Change from week 56 to week 82	0.92	—
PlaceboChange from week 0 to week 30	1.04	—
Change from week 0 to week 56	0.97	—
Change from week 56 to week 82	0.94	—

Secondary/registry result

Change in Glycaemic Category

Time frame:Week -2, week 30, week 56 and week 82

categorical status, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide 3.0 mgWeek -2	93	—
Week -2	31	—
Week -2	1	—
Week 30	95	—
Week 30	19	—
Week 30	2	—
Week 56	86	—
Week 56	17	—
Week 56	2	—
Week 82	79	—
Week 82	20	—
Week 82	1	—
PlaceboWeek -2	93	—
Week -2	32	—
Week -2	1	—
Week 30	86	—
Week 30	29	—
Week 30	1	—
Week 56	75	—
Week 56	24	—
Week 56	2	—
Week 82	65	—
Week 82	30	—
Week 82	4	—

Secondary/registry result

Change in HOMA-B (Ratio to Baseline)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of HOMA-B	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	1.32	—
Change from week 0 to week 56	1.13	—
Change from week 56 to week 82	0.92	—
PlaceboChange from week 0 to week 30	1.17	—
Change from week 0 to week 56	1.11	—
Change from week 56 to week 82	1.02	—

Secondary/registry result

Change in HOMA-IR (Ratio to Baseline)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

HOMA-IR (insulin sensitivity)

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of HOMA-IR	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	1.08	—
Change from week 0 to week 56	1.04	—
Change from week 56 to week 82	1.03	—
PlaceboChange from week 0 to week 30	1.14	—
Change from week 0 to week 56	1.09	—
Change from week 56 to week 82	1.11	—

Secondary/protocol endpoint

Change in HbA1c

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in FPG

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Fasting Insulin (Ratio to Baseline)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

ratio, improvement

Secondary/protocol endpoint

Change in Fasting C-peptide (Ratio to Baseline)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

ratio, improvement

Secondary/protocol endpoint

Change in Glycaemic Category

Time frame:Week -2, week 30, week 56 and week 82

categorical status, improvement

Secondary/protocol endpoint

Change in HOMA-B (Ratio to Baseline)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

ratio, improvement

Secondary/protocol endpoint

Change in HOMA-IR (Ratio to Baseline)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

HOMA-IR (insulin sensitivity)

ratio, improvement

Renal / kidney

1 endpoint

Secondary/registry result/low confidence

Change in Biochemistry: Creatinine and Bilirubin (Total)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, descriptive

Posted result

Group	Value (mean), umol/L	95% CI
Liraglutide 3.0 mgCreatinine: Change from week 0 to week 30	1	—
Creatinine: Change from week 0 to week 56	2	—
Creatinine: Change from week 56 to week 82	2	—
Bilirubin (total): Change from week 0 to week 30	1	—
Bilirubin (total): Change from week 0 to week 56	1	—
Bilirubin (total): Change from week 56 to week 82	0	—
PlaceboCreatinine: Change from week 0 to week 30	0	—
Creatinine: Change from week 0 to week 56	4	—
Creatinine: Change from week 56 to week 82	1	—
Bilirubin (total): Change from week 0 to week 30	1	—
Bilirubin (total): Change from week 0 to week 56	1	—
Bilirubin (total): Change from week 56 to week 82	-0	—

Cardiometabolic biomarkers

23 endpoints

Secondary/registry result

Change in hsCRP

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Posted result

Group	Value (mean), mg/L	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	-0.22	—
Change from week 0 to week 56	-0.25	—
Change from week 56 to week 82	1.51	—
PlaceboChange from week 0 to week 30	-0.56	—
Change from week 0 to week 56	-0.14	—
Change from week 56 to week 82	1.00	—

Secondary/registry result

Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

Group	Value (geometric_mean), Ratio of total cholesterol	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	1.00	—
Change from week 0 to week 56	1.00	—
Change from week 56 to week 82	1.02	—
PlaceboChange from week 0 to week 30	0.98	—
Change from week 0 to week 56	1.00	—
Change from week 56 to week 82	1.02	—

Secondary/registry result

Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (geometric_mean), Ratio of LDL-cholesterol	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	1.00	—
Change from week 0 to week 56	0.99	—
Change from week 56 to week 82	1.03	—
PlaceboChange from week 0 to week 30	1.00	—
Change from week 0 to week 56	1.02	—
Change from week 56 to week 82	1.04	—

Secondary/registry result

Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (geometric_mean), Ratio of HDL-cholesterol	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	1.04	—
Change from week 0 to week 56	1.04	—
Change from week 56 to week 82	0.99	—
PlaceboChange from week 0 to week 30	1.01	—
Change from week 0 to week 56	1.02	—
Change from week 56 to week 82	1.00	—

Secondary/registry result

Change in Fasting Lipid: Non-HDL Cholesterol (Ratio to Baseline)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Non-HDL cholesterol, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of non-HDL cholesterol	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	0.98	—
Change from week 0 to week 56	0.98	—
Change from week 56 to week 82	1.03	—
PlaceboChange from week 0 to week 30	0.97	—
Change from week 0 to week 56	0.99	—
Change from week 56 to week 82	1.02	—

Secondary/registry result

Change in Fasting Lipid: VLDL Cholesterol (Ratio to Baseline)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

VLDL, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of VLDL cholesterol	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	0.91	—
Change from week 0 to week 56	0.92	—
Change from week 56 to week 82	1.04	—
PlaceboChange from week 0 to week 30	0.90	—
Change from week 0 to week 56	0.93	—
Change from week 56 to week 82	0.97	—

Secondary/registry result

Change in Fasting Lipid: Triglycerides (Ratio to Baseline)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (geometric_mean), Ratio of triglycerides	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	0.91	—
Change from week 0 to week 56	0.92	—
Change from week 56 to week 82	1.04	—
PlaceboChange from week 0 to week 30	0.91	—
Change from week 0 to week 56	0.93	—
Change from week 56 to week 82	0.97	—

Secondary/registry result

Change in Fasting Lipid: FFA (Ratio to Baseline)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Free fatty acids, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of FFA	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	0.96	—
Change from week 0 to week 56	1.00	—
Change from week 56 to week 82	0.99	—
PlaceboChange from week 0 to week 30	0.83	—
Change from week 0 to week 56	0.95	—
Change from week 56 to week 82	0.94	—

Secondary/registry result

Change in Systolic and Diastolic Blood Pressure

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Posted result

Group	Value (mean), mmHg	95% CI
Liraglutide 3.0 mgSBP: Change from week 0 to week 30	-2	—
SBP: Change from week 0 to week 56	-2	—
SBP: Change from week 56 to week 82	2	—
DBP: Change from week 0 to week 30	-0	—
DBP: Change from week 0 to week 56	1	—
DBP: Change from week 56 to week 82	2	—
PlaceboSBP: Change from week 0 to week 30	-1	—
SBP: Change from week 0 to week 56	1	—
SBP: Change from week 56 to week 82	1	—
DBP: Change from week 0 to week 30	-1	—
DBP: Change from week 0 to week 56	-1	—
DBP: Change from week 56 to week 82	2	—

Secondary/registry result

Change in Pulse

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats/minute	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	4	—
Change from week 0 to week 56	4	—
Change from week 56 to week 82	-3	—
PlaceboChange from week 0 to week 30	-1	—
Change from week 0 to week 56	-1	—
Change from week 56 to week 82	2	—

Secondary/registry result

Change in Hormone Level: IGF-1 and Cortisol

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

IGF-1; cortisol

change from baseline, descriptive

Posted result

Group	Value (mean), ng/mL	95% CI
Liraglutide 3.0 mgIGF-1: Change from week 0 to week 30	10.61	—
IGF-1: Change from week 0 to week 56	-4.60	—
IGF-1: Change from week 56 to week 82	-14.60	—
Cortisol: Change from week 0 to week 30	6.9	—
Cortisol: Change from week 0 to week 56	5.1	—
Cortisol: Change from week 56 to week 82	0.6	—
PlaceboIGF-1: Change from week 0 to week 30	3.79	—
IGF-1: Change from week 0 to week 56	3.69	—
IGF-1: Change from week 56 to week 82	-16.35	—
Cortisol: Change from week 0 to week 30	8.6	—
Cortisol: Change from week 0 to week 56	8.5	—
Cortisol: Change from week 56 to week 82	10.4	—

Secondary/registry result

Change in Hormone Level: Estradiol (Females)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

estradiol change

change from baseline, descriptive

Posted result

Group	Value (mean), pg/mL	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	-5.0	—
Change from week 0 to week 56	11.6	—
Change from week 56 to week 82	-2.3	—
PlaceboChange from week 0 to week 30	20.2	—
Change from week 0 to week 56	14.1	—
Change from week 56 to week 82	-1.7	—

Secondary/registry result

Change in CTX1

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

CTX1

change from baseline, descriptive

Posted result

Group	Value (mean), pg/mL	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	-7	—
Change from week 0 to week 56	-36	—
Change from week 56 to week 82	-107	—
PlaceboChange from week 0 to week 30	-84	—
Change from week 0 to week 56	-97	—
Change from week 56 to week 82	-162	—

Secondary/protocol endpoint

Change in hsCRP

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Fasting Lipid: Non-HDL Cholesterol (Ratio to Baseline)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Non-HDL cholesterol, change

ratio, improvement

Secondary/protocol endpoint

Change in Fasting Lipid: VLDL Cholesterol (Ratio to Baseline)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change in Fasting Lipid: Triglycerides (Ratio to Baseline)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Fasting Lipid: FFA (Ratio to Baseline)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Change in Systolic and Diastolic Blood Pressure

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Secondary/protocol endpoint

Change in Pulse

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

4 endpoints

Secondary/registry result

Change in IWQOL-Kids

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

IWQOL-Lite total

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	95% CI
Liraglutide 3.0 mgBody Esteem: Change from week 0 to week 30	10.62	—
Body Esteem: Change from week 0 to week 56	13.33	—
Family Relation: Change from week 0 to week 30	2.53	—
Family Relation: Change from week 0 to week 56	1.44	—
Physical Function: Change from week 0 to week 30	3.94	—
Physical Function: Change from week 0 to week 56	6.17	—
Social Life: Change from week 0 to week 30	5.32	—
Social Life: Change from week 0 to week 56	5.97	—
Total: Change from week 0 to week 30	6.16	—
Total: Change from week 0 to week 56	7.46	—
PlaceboBody Esteem: Change from week 0 to week 30	6.73	—
Body Esteem: Change from week 0 to week 56	13.24	—
Family Relation: Change from week 0 to week 30	-2.19	—
Family Relation: Change from week 0 to week 56	0.97	—
Physical Function: Change from week 0 to week 30	0.43	—
Physical Function: Change from week 0 to week 56	3.32	—
Social Life: Change from week 0 to week 30	1.76	—
Social Life: Change from week 0 to week 56	6.06	—
Total: Change from week 0 to week 30	2.24	—
Total: Change from week 0 to week 56	6.72	—

Secondary/registry result

Change in PHQ-9

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	-1	—
Change from week 0 to week 56	-1	—
Change from week 56 to week 82	0	—
PlaceboChange from week 0 to week 30	-1	—
Change from week 0 to week 56	-2	—
Change from week 56 to week 82	-0	—

Secondary/protocol endpoint

Change in IWQOL-Kids

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

Change in PHQ-9

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, improvement

Safety / tolerability / PK

33 endpoints

Secondary/registry result

Number of Treatment Emergent Adverse Events

Time frame:Week 0-56 + 14 days

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Liraglutide 3.0 mg	777	—
Placebo	627	—

Secondary/registry result

Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification)

Time frame:Week 0-56 + 14 days

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), Episodes	95% CI
Liraglutide 3.0 mgSevere hypoglycaemia	0	—
Asymptomatic hypoglycaemia	12	—
Documented symptomatic hypoglycaemia	31	—
Probable symptomatic hypoglycaemia	1	—
Pseudo-hypoglycaemia	30	—
Unclassifiable	4	—
PlaceboSevere hypoglycaemia	0	—
Asymptomatic hypoglycaemia	17	—
Documented symptomatic hypoglycaemia	6	—
Probable symptomatic hypoglycaemia	2	—
Pseudo-hypoglycaemia	3	—
Unclassifiable	0	—

Secondary/registry result

Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification)

Time frame:Week 0-56 + 14 days

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), Episodes	95% CI
Liraglutide 3.0 mgSevere hypoglycaemia	0	—
Asymptomatic BG-confirmed hypoglycaemia	1	—
Symptomatic BG-confirmed hypoglycaemia	4	—
Unclassifiable	73	—
PlaceboSevere hypoglycaemia	0	—
Asymptomatic BG-confirmed hypoglycaemia	1	—
Symptomatic BG-confirmed hypoglycaemia	0	—
Unclassifiable	27	—

Secondary/registry result

Occurrence of Anti-liraglutide Antibodies

Time frame:Weeks 0, 30, 56, 58, 70 and 82

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide 3.0 mgWeeks 0	0	—
Weeks 30	6	—
Weeks 56	5	—
Weeks 58	11	—
Weeks 70	6	—
Weeks 82	2	—

Secondary/registry result

Change in ECG

Time frame:Week -14, week 30, week 56 and week 82

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide 3.0 mgWeek -14	102	—
Week -14	23	—
Week -14	0	—
Week 30	97	—
Week 30	20	—
Week 30	0	—
Week 56	83	—
Week 56	21	—
Week 56	0	—
PlaceboWeek -14	100	—
Week -14	26	—
Week -14	0	—
Week 30	95	—
Week 30	21	—
Week 30	0	—
Week 56	80	—
Week 56	23	—
Week 56	0	—

Secondary/registry result

Change in Haematology: Haemoglobin

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

haemoglobin

change from baseline, descriptive

LOINC 718-7

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	0.2	—
Change from week 0 to week 56	0.3	—
Change from week 56 to week 82	-0.1	—
PlaceboChange from week 0 to week 30	0.0	—
Change from week 0 to week 56	0.1	—
Change from week 56 to week 82	-0.0	—

Secondary/registry result

Change in Haematology: Haematocrit

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, descriptive

Posted result

Group	Value (mean), % of red blood cells	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	0.7	—
Change from week 0 to week 56	1.2	—
Change from week 56 to week 82	-0.4	—
PlaceboChange from week 0 to week 30	0.1	—
Change from week 0 to week 56	0.4	—
Change from week 56 to week 82	-0.4	—

Secondary/registry result

Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, descriptive

Posted result

Group	Value (mean), 10^9 cells/L	95% CI
Liraglutide 3.0 mgThrombocytes: Change from week 0 to week 30	9	—
Thrombocytes: Change from week 0 to week 56	7	—
Thrombocytes: Change from week 56 to week 82	-2	—
Leucocytes: Change from week 0 to week 30	0.1	—
Leucocytes: Change from week 0 to week 56	-0.2	—
Leucocytes: Change from week 56 to week 82	0.2	—
Eosinophils: Change from week 0 to week 30	0.03	—
Eosinophils: Change from week 0 to week 56	0.01	—
Eosinophils: Change from week 56 to week 82	-0.01	—
Neutrophils: Change from week 0 to week 30	0.18	—
Neutrophils: Change from week 0 to week 56	-0.01	—
Neutrophils: Change from week 56 to week 82	0.21	—
Basophils: Change from week 0 to week 30	0.01	—
Basophils: Change from week 0 to week 56	0.01	—
Basophils: Change from week 56 to week 82	0.00	—
Lymphocytes: Change from week 0 to week 30	-0.18	—
Lymphocytes: Change from week 0 to week 56	-0.28	—
Lymphocytes: Change from week 56 to week 82	-0.03	—
Monocytes: Change from week 0 to week 30	0.04	—
Monocytes: Change from week 0 to week 56	0.06	—
Monocytes: Change from week 56 to week 82	-0.00	—
PlaceboThrombocytes: Change from week 0 to week 30	14	—
Thrombocytes: Change from week 0 to week 56	7	—
Thrombocytes: Change from week 56 to week 82	3	—
Leucocytes: Change from week 0 to week 30	-0.1	—
Leucocytes: Change from week 0 to week 56	-0.4	—
Leucocytes: Change from week 56 to week 82	0.0	—
Eosinophils: Change from week 0 to week 30	0.04	—
Eosinophils: Change from week 0 to week 56	0.00	—
Eosinophils: Change from week 56 to week 82	0.00	—
Neutrophils: Change from week 0 to week 30	-0.01	—
Neutrophils: Change from week 0 to week 56	-0.13	—
Neutrophils: Change from week 56 to week 82	-0.00	—
Basophils: Change from week 0 to week 30	0.01	—
Basophils: Change from week 0 to week 56	0.02	—
Basophils: Change from week 56 to week 82	0.00	—
Lymphocytes: Change from week 0 to week 30	-0.14	—
Lymphocytes: Change from week 0 to week 56	-0.27	—
Lymphocytes: Change from week 56 to week 82	-0.00	—
Monocytes: Change from week 0 to week 30	0.00	—
Monocytes: Change from week 0 to week 56	0.01	—
Monocytes: Change from week 56 to week 82	0.04	—

Secondary/registry result

Change in Haematology: Erythrocytes

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

erythrocyte count

change from baseline, descriptive

Posted result

Group	Value (mean), 10^12 cells/L	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	0.0	—
Change from week 0 to week 56	-0.0	—
Change from week 56 to week 82	-0.1	—
PlaceboChange from week 0 to week 30	-0.0	—
Change from week 0 to week 56	-0.1	—
Change from week 56 to week 82	0.0	—

Secondary/registry result

Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, descriptive

componentscreatine kinase change, amylase change, lipase change, ALT, change, AST, change, alkaline phosphatase change

Posted result

Group	Value (mean), U/L	95% CI
Liraglutide 3.0 mgCreatinine kinase: Change from week 0 to week 30	13	—
Creatinine kinase: Change from week 0 to week 56	32	—
Creatinine kinase: Change from week 56 to week 82	28	—
Amylase: Change from week 0 to week 30	4	—
Amylase: Change from week 0 to week 56	2	—
Amylase: Change from week 56 to week 82	-1	—
Lipase: Change from week 0 to week 30	6	—
Lipase: Change from week 0 to week 56	3	—
Lipase: Change from week 56 to week 82	-4	—
ALT: Change from week 0 to week 30	-2	—
ALT: Change from week 0 to week 56	-2	—
ALT: Change from week 56 to week 82	1	—
AST: Change from week 0 to week 30	-1	—
AST: Change from week 0 to week 56	-1	—
AST: Change from week 56 to week 82	1	—
ALP: Change from week 0 to week 30	-16	—
ALP: Change from week 0 to week 56	-23	—
ALP: Change from week 56 to week 82	-2	—
PlaceboCreatinine kinase: Change from week 0 to week 30	0	—
Creatinine kinase: Change from week 0 to week 56	0	—
Creatinine kinase: Change from week 56 to week 82	4	—
Amylase: Change from week 0 to week 30	3	—
Amylase: Change from week 0 to week 56	-0	—
Amylase: Change from week 56 to week 82	1	—
Lipase: Change from week 0 to week 30	1	—
Lipase: Change from week 0 to week 56	-2	—
Lipase: Change from week 56 to week 82	-0	—
ALT: Change from week 0 to week 30	-1	—
ALT: Change from week 0 to week 56	-0	—
ALT: Change from week 56 to week 82	2	—
AST: Change from week 0 to week 30	-1	—
AST: Change from week 0 to week 56	-1	—
AST: Change from week 56 to week 82	1	—
ALP: Change from week 0 to week 30	-8	—
ALP: Change from week 0 to week 56	-19	—
ALP: Change from week 56 to week 82	-10	—

Secondary/registry result

Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, descriptive

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide 3.0 mgUrea (BUN): Change from week 0 to week 30	-0.06	—
Urea (BUN): Change from week 0 to week 56	-0.26	—
Urea (BUN): Change from week 56 to week 82	0.23	—
Sodium: Change from week 0 to week 30	0	—
Sodium: Change from week 0 to week 56	0	—
Sodium: Change from week 56 to week 82	-1	—
Potassium: Change from week 0 to week 30	-0.0	—
Potassium: Change from week 0 to week 56	-0.1	—
Potassium: Change from week 56 to week 82	0.0	—
Calcium total: Change from week 0 to week 30	-0.01	—
Calcium total: Change from week 0 to week 56	-0.04	—
Calcium total: Change from week 56 to week 82	-0.00	—
Ca albumin-corrected:Change from week 0 to week 30	-0.04	—
Ca albumin-corrected:Change from week 0 to week 56	-0.07	—
Ca albumin-corrected: Change from Wk 56 to Wk 82	0.01	—
PlaceboUrea (BUN): Change from week 0 to week 30	0.00	—
Urea (BUN): Change from week 0 to week 56	-0.05	—
Urea (BUN): Change from week 56 to week 82	0.00	—
Sodium: Change from week 0 to week 30	0	—
Sodium: Change from week 0 to week 56	0	—
Sodium: Change from week 56 to week 82	-1	—
Potassium: Change from week 0 to week 30	0.0	—
Potassium: Change from week 0 to week 56	-0.0	—
Potassium: Change from week 56 to week 82	-0.0	—
Calcium total: Change from week 0 to week 30	-0.03	—
Calcium total: Change from week 0 to week 56	-0.04	—
Calcium total: Change from week 56 to week 82	-0.01	—
Ca albumin-corrected:Change from week 0 to week 30	-0.03	—
Ca albumin-corrected:Change from week 0 to week 56	-0.07	—
Ca albumin-corrected: Change from Wk 56 to Wk 82	-0.00	—

Secondary/registry result

Change in Biochemistry: Albumin

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

albumin serum

change from baseline, descriptive

LOINC 1751-7

Posted result

Group	Value (mean), g/dL	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	0.1	—
Change from week 0 to week 56	0.1	—
Change from week 56 to week 82	-0.0	—
PlaceboChange from week 0 to week 30	0.0	—
Change from week 0 to week 56	0.1	—
Change from week 56 to week 82	-0.0	—

Secondary/registry result

Change in Biochemistry: CEA

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, descriptive

Posted result

Group	Value (mean), ng/mL	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	-0.0	—
Change from week 0 to week 56	0.0	—
Change from week 56 to week 82	0.0	—
PlaceboChange from week 0 to week 30	-0.1	—
Change from week 0 to week 56	-0.0	—
Change from week 56 to week 82	0.0	—

Secondary/registry result

Change in Hormone Level: Calcitonin

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Thyroid event

change from baseline, descriptive

Posted result

Group	Value (mean), ng/L	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	0.1	—
Change from week 0 to week 56	0.0	—
Change from week 56 to week 82	-0.1	—
PlaceboChange from week 0 to week 30	0.1	—
Change from week 0 to week 56	-0.0	—
Change from week 56 to week 82	0.2	—

Secondary/registry result

Change in Hormone Level: TSH and Prolactin

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, descriptive

Posted result

Group	Value (mean), mIU/L	95% CI
Liraglutide 3.0 mgTSH: Change from week 0 to week 30	-0.35	—
TSH: Change from week 0 to week 56	-0.42	—
TSH: Change from week 56 to week 82	0.38	—
Prolactin: Change from week 0 to week 30	23	—
Prolactin: Change from week 0 to week 56	63	—
Prolactin: Change from week 56 to week 82	-29	—
PlaceboTSH: Change from week 0 to week 30	-0.08	—
TSH: Change from week 0 to week 56	-0.14	—
TSH: Change from week 56 to week 82	0.13	—
Prolactin: Change from week 0 to week 30	-47	—
Prolactin: Change from week 0 to week 56	-63	—
Prolactin: Change from week 56 to week 82	13	—

Secondary/registry result

Change in Hormone Level: Free T4 and ACTH

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, descriptive

Posted result

Group	Value (mean), pmol/L	95% CI
Liraglutide 3.0 mgT4: Change from week 0 to week 30	0.6	—
T4: Change from week 0 to week 56	0.3	—
T4: Change from week 56 to week 82	0.0	—
ACTH: Change from week 0 to week 30	0.4	—
ACTH: Change from week 0 to week 56	0.6	—
ACTH: Change from week 56 to week 82	-0.8	—
PlaceboT4: Change from week 0 to week 30	0.8	—
T4: Change from week 0 to week 56	0.6	—
T4: Change from week 56 to week 82	0.2	—
ACTH: Change from week 0 to week 30	0.5	—
ACTH: Change from week 0 to week 56	0.6	—
ACTH: Change from week 56 to week 82	-0.4	—

Secondary/registry result

Change in Alkaline Phosphatase (Bone)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, descriptive

Posted result

Group	Value (mean), U/L	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	-15	—
Change from week 0 to week 56	-17	—
Change from week 56 to week 82	-1	—
PlaceboChange from week 0 to week 30	-12	—
Change from week 0 to week 56	-17	—
Change from week 56 to week 82	-4	—

Secondary/registry result

Change in Physical Examination

Time frame:Week 0, week 30, week 56 and week 82

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide 3.0 mgGeneral Appearance: Week 0	93	—
General Appearance: Week 0	30	—
General Appearance: Week 0	2	—
General Appearance: Week 30	94	—
General Appearance: Week 30	21	—
General Appearance: Week 30	1	—
General Appearance: Week 56	84	—
General Appearance: Week 56	18	—
General Appearance: Week 56	2	—
General Appearance: Week 82	80	—
General Appearance: Week 82	18	—
General Appearance: Week 82	1	—
Head, ears, eyes, nose, throat, neck: Week 0	120	—
Head, ears, eyes, nose, throat, neck: Week 0	5	—
Head, ears, eyes, nose, throat, neck: Week 0	0	—
Head, ears, eyes, nose, throat, neck: Week 30	114	—
Head, ears, eyes, nose, throat, neck: Week 30	2	—
Head, ears, eyes, nose, throat, neck: Week 30	0	—
Head, ears, eyes, nose, throat, neck: Week 56	101	—
Head, ears, eyes, nose, throat, neck: Week 56	3	—
Head, ears, eyes, nose, throat, neck: Week 56	0	—
Head, ears, eyes, nose, throat, neck: Week 82	98	—
Head, ears, eyes, nose, throat, neck: Week 82	1	—
Head, ears, eyes, nose, throat, neck: Week 82	0	—
Respiratory system: Week 0	125	—
Respiratory system: Week 0	0	—
Respiratory system: Week 0	0	—
Respiratory system: Week 30	116	—
Respiratory system: Week 30	0	—
Respiratory system: Week 30	0	—
Respiratory system: Week 56	104	—
Respiratory system: Week 56	0	—
Respiratory system: Week 56	0	—
Respiratory system: Week 82	99	—
Respiratory system: Week 82	0	—
Respiratory system: Week 82	0	—
Cardiovascular system: Week 0	124	—
Cardiovascular system: Week 0	1	—
Cardiovascular system: Week 0	0	—
Cardiovascular system: Week 30	115	—
Cardiovascular system: Week 30	1	—
Cardiovascular system: Week 30	0	—
Cardiovascular system: Week 56	102	—
Cardiovascular system: Week 56	2	—
Cardiovascular system: Week 56	0	—
Cardiovascular system: Week 82	97	—
Cardiovascular system: Week 82	2	—
Cardiovascular system: Week 82	0	—
GI system including mouth: Week 0	119	—
GI system including mouth: Week 0	5	—
GI system including mouth: Week 0	1	—
GI system including mouth: Week 30	111	—
GI system including mouth: Week 30	5	—
GI system including mouth: Week 30	0	—
GI system including mouth: Week 56	102	—
GI system including mouth: Week 56	2	—
GI system including mouth: Week 56	0	—
GI system including mouth: Week 82	96	—
GI system including mouth: Week 82	1	—
GI system including mouth: Week 82	2	—
Musculoskeletal system: Week 0	121	—
Musculoskeletal system: Week 0	4	—
Musculoskeletal system: Week 0	0	—
Musculoskeletal system: Week 30	113	—
Musculoskeletal system: Week 30	3	—
Musculoskeletal system: Week 30	0	—
Musculoskeletal system: Week 56	102	—
Musculoskeletal system: Week 56	1	—
Musculoskeletal system: Week 56	1	—
Musculoskeletal system: Week 82	97	—
Musculoskeletal system: Week 82	1	—
Musculoskeletal system: Week 82	1	—
CNS and PNS: Week 0	124	—
CNS and PNS: Week 0	1	—
CNS and PNS: Week 0	0	—
CNS and PNS: Week 30	115	—
CNS and PNS: Week 30	1	—
CNS and PNS: Week 30	0	—
CNS and PNS: Week 56	104	—
CNS and PNS: Week 56	0	—
CNS and PNS: Week 56	0	—
CNS and PNS: Week 82	99	—
CNS and PNS: Week 82	0	—
CNS and PNS: Week 82	0	—
Skin: Week 0	76	—
Skin: Week 0	47	—
Skin: Week 0	2	—
Skin: Week 30	71	—
Skin: Week 30	44	—
Skin: Week 30	1	—
Skin: Week 56	65	—
Skin: Week 56	35	—
Skin: Week 56	4	—
Skin: Week 82	57	—
Skin: Week 82	40	—
Skin: Week 82	2	—
Thyroid gland: Week 0	124	—
Thyroid gland: Week 0	1	—
Thyroid gland: Week 0	0	—
Thyroid gland: Week 30	115	—
Thyroid gland: Week 30	1	—
Thyroid gland: Week 30	0	—
Thyroid gland: Week 56	103	—
Thyroid gland: Week 56	1	—
Thyroid gland: Week 56	0	—
Thyroid gland: Week 82	97	—
Thyroid gland: Week 82	2	—
Thyroid gland: Week 82	0	—
Lymph node palpation: Week 0	124	—
Lymph node palpation: Week 0	1	—
Lymph node palpation: Week 0	0	—
Lymph node palpation: Week 30	115	—
Lymph node palpation: Week 30	1	—
Lymph node palpation: Week 30	0	—
Lymph node palpation: Week 56	103	—
Lymph node palpation: Week 56	1	—
Lymph node palpation: Week 56	0	—
Lymph node palpation: Week 82	98	—
Lymph node palpation: Week 82	1	—
Lymph node palpation: Week 82	0	—
PlaceboGeneral Appearance: Week 0	101	—
General Appearance: Week 0	23	—
General Appearance: Week 0	2	—
General Appearance: Week 30	95	—
General Appearance: Week 30	20	—
General Appearance: Week 30	1	—
General Appearance: Week 56	85	—
General Appearance: Week 56	16	—
General Appearance: Week 56	1	—
General Appearance: Week 82	81	—
General Appearance: Week 82	17	—
General Appearance: Week 82	1	—
Head, ears, eyes, nose, throat, neck: Week 0	116	—
Head, ears, eyes, nose, throat, neck: Week 0	10	—
Head, ears, eyes, nose, throat, neck: Week 0	0	—
Head, ears, eyes, nose, throat, neck: Week 30	107	—
Head, ears, eyes, nose, throat, neck: Week 30	9	—
Head, ears, eyes, nose, throat, neck: Week 30	0	—
Head, ears, eyes, nose, throat, neck: Week 56	98	—
Head, ears, eyes, nose, throat, neck: Week 56	4	—
Head, ears, eyes, nose, throat, neck: Week 56	0	—
Head, ears, eyes, nose, throat, neck: Week 82	94	—
Head, ears, eyes, nose, throat, neck: Week 82	5	—
Head, ears, eyes, nose, throat, neck: Week 82	0	—
Respiratory system: Week 0	123	—
Respiratory system: Week 0	3	—
Respiratory system: Week 0	0	—
Respiratory system: Week 30	115	—
Respiratory system: Week 30	1	—
Respiratory system: Week 30	0	—
Respiratory system: Week 56	101	—
Respiratory system: Week 56	1	—
Respiratory system: Week 56	0	—
Respiratory system: Week 82	96	—
Respiratory system: Week 82	3	—
Respiratory system: Week 82	0	—
Cardiovascular system: Week 0	125	—
Cardiovascular system: Week 0	1	—
Cardiovascular system: Week 0	0	—
Cardiovascular system: Week 30	112	—
Cardiovascular system: Week 30	4	—
Cardiovascular system: Week 30	0	—
Cardiovascular system: Week 56	100	—
Cardiovascular system: Week 56	2	—
Cardiovascular system: Week 56	0	—
Cardiovascular system: Week 82	98	—
Cardiovascular system: Week 82	1	—
Cardiovascular system: Week 82	0	—
GI system including mouth: Week 0	119	—
GI system including mouth: Week 0	6	—
GI system including mouth: Week 0	1	—
GI system including mouth: Week 30	109	—
GI system including mouth: Week 30	6	—
GI system including mouth: Week 30	1	—
GI system including mouth: Week 56	98	—
GI system including mouth: Week 56	4	—
GI system including mouth: Week 56	0	—
GI system including mouth: Week 82	94	—
GI system including mouth: Week 82	5	—
GI system including mouth: Week 82	0	—
Musculoskeletal system: Week 0	119	—
Musculoskeletal system: Week 0	7	—
Musculoskeletal system: Week 0	0	—
Musculoskeletal system: Week 30	106	—
Musculoskeletal system: Week 30	10	—
Musculoskeletal system: Week 30	0	—
Musculoskeletal system: Week 56	97	—
Musculoskeletal system: Week 56	5	—
Musculoskeletal system: Week 56	0	—
Musculoskeletal system: Week 82	92	—
Musculoskeletal system: Week 82	7	—
Musculoskeletal system: Week 82	0	—
CNS and PNS: Week 0	124	—
CNS and PNS: Week 0	2	—
CNS and PNS: Week 0	0	—
CNS and PNS: Week 30	115	—
CNS and PNS: Week 30	1	—
CNS and PNS: Week 30	0	—
CNS and PNS: Week 56	101	—
CNS and PNS: Week 56	1	—
CNS and PNS: Week 56	0	—
CNS and PNS: Week 82	98	—
CNS and PNS: Week 82	1	—
CNS and PNS: Week 82	0	—
Skin: Week 0	58	—
Skin: Week 0	64	—
Skin: Week 0	4	—
Skin: Week 30	56	—
Skin: Week 30	56	—
Skin: Week 30	4	—
Skin: Week 56	48	—
Skin: Week 56	53	—
Skin: Week 56	1	—
Skin: Week 82	50	—
Skin: Week 82	48	—
Skin: Week 82	1	—
Thyroid gland: Week 0	124	—
Thyroid gland: Week 0	2	—
Thyroid gland: Week 0	0	—
Thyroid gland: Week 30	114	—
Thyroid gland: Week 30	2	—
Thyroid gland: Week 30	0	—
Thyroid gland: Week 56	101	—
Thyroid gland: Week 56	1	—
Thyroid gland: Week 56	0	—
Thyroid gland: Week 82	98	—
Thyroid gland: Week 82	1	—
Thyroid gland: Week 82	0	—
Lymph node palpation: Week 0	125	—
Lymph node palpation: Week 0	1	—
Lymph node palpation: Week 0	0	—
Lymph node palpation: Week 30	116	—
Lymph node palpation: Week 30	0	—
Lymph node palpation: Week 30	0	—
Lymph node palpation: Week 56	102	—
Lymph node palpation: Week 56	0	—
Lymph node palpation: Week 56	0	—
Lymph node palpation: Week 82	98	—
Lymph node palpation: Week 82	1	—
Lymph node palpation: Week 82	0	—

Secondary/registry result

Change in C-SSRS

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide 3.0 mgWk 0: Suicidal ideation	2	—
Wk 0: Suicidal behaviour	0	—
Wk0: Self-injurious behaviour, no suicidal intent	0	—
Wk 30: Suicidal ideation	0	—
Wk 30: Suicidal behaviour	0	—
Wk30: Self-injurious behaviour, no suicidal intent	0	—
Wk 56: Suicidal ideation	0	—
Wk 56: Suicidal behaviour	0	—
Wk56: Self-injurious behaviour, no suicidal intent	0	—
Wk 82: Suicidal ideation	0	—
Wk 82: Suicidal behaviour	0	—
Wk82: Self-injurious behaviour, no suicidal intent	0	—
PlaceboWk 0: Suicidal ideation	2	—
Wk 0: Suicidal behaviour	1	—
Wk0: Self-injurious behaviour, no suicidal intent	1	—
Wk 30: Suicidal ideation	0	—
Wk 30: Suicidal behaviour	0	—
Wk30: Self-injurious behaviour, no suicidal intent	0	—
Wk 56: Suicidal ideation	0	—
Wk 56: Suicidal behaviour	0	—
Wk56: Self-injurious behaviour, no suicidal intent	0	—
Wk 82: Suicidal ideation	0	—
Wk 82: Suicidal behaviour	0	—
Wk82: Self-injurious behaviour, no suicidal intent	0	—

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events

Time frame:Week 0-56 + 14 days

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification)

Time frame:Week 0-56 + 14 days

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification)

Time frame:Week 0-56 + 14 days

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Occurrence of Anti-liraglutide Antibodies

Time frame:Weeks 0, 30, 56, 58, 70 and 82

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Change in ECG

Time frame:Week -14, week 30, week 56 and week 82

categorical status, descriptive

Secondary/protocol endpoint

Change in Haematology: Haematocrit

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematology: Erythrocytes

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, descriptive

Secondary/protocol endpoint

Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, descriptive

Secondary/protocol endpoint

Change in Hormone Level: Calcitonin

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Thyroid event

change from baseline, descriptive

Secondary/protocol endpoint

Change in Hormone Level: TSH and Prolactin

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, descriptive

Secondary/protocol endpoint

Change in Hormone Level: Free T4 and ACTH

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, descriptive

componentsfree t4 change, acth change

Secondary/protocol endpoint

Change in Physical Examination

Time frame:Week 0, week 30, week 56 and week 82

descriptive

Secondary/protocol endpoint

Change in C-SSRS

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

threshold achievement, event

Other clinical outcomes

15 endpoints

Secondary/registry result/low confidence

Change in Nutritional Compliance

Time frame:Week 0, week 30 and week 56

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Liraglutide 3.0 mgWeek 0	7.10	—
Week 30	6.74	—
Week 56	6.87	—
PlaceboWeek 0	7.07	—
Week 30	6.51	—
Week 56	6.45	—

Secondary/registry result

Change in Hormone Level: DHEAS

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Androgen, change

change from baseline, improvement

Posted result

Group	Value (mean), umol/L	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	0.94	—
Change from week 0 to week 56	0.95	—
Change from week 56 to week 82	-0.08	—
PlaceboChange from week 0 to week 30	0.57	—
Change from week 0 to week 56	0.89	—
Change from week 56 to week 82	-0.05	—

Secondary/registry result

Change in Hormone Level: LH and FSH

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, descriptive

Posted result

Group	Value (mean), IU/L	95% CI
Liraglutide 3.0 mgLH: Change from week 0 to week 30	0.4	—
LH: Change from week 0 to week 56	0.2	—
LH: Change from week 56 to week 82	0.4	—
FSH: Change from week 0 to week 30	0.2	—
FSH: Change from week 0 to week 56	0.6	—
FSH: Change from week 56 to week 82	-0.1	—
PlaceboLH: Change from week 0 to week 30	0.7	—
LH: Change from week 0 to week 56	0.6	—
LH: Change from week 56 to week 82	-0.5	—
FSH: Change from week 0 to week 30	-0.2	—
FSH: Change from week 0 to week 56	0.1	—
FSH: Change from week 56 to week 82	-0.1	—

Secondary/registry result

Change in Hormone Level: Testosterone (Males)

Time frame:Week 0, week 30, week 56 and week 82

Androgen, change

change from baseline, improvement

Posted result

Group	Value (mean), nmol/L	95% CI
Liraglutide 3.0 mgWeek 0	8.13	—
Week 30	10.00	—
Week 56	10.55	—
Week 82	11.36	—
PlaceboWeek 0	8.06	—
Week 30	9.33	—
Week 56	9.51	—
Week 82	6.16	—

Secondary/registry result

Change in NTX1

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

NTX1

change from baseline, descriptive

Posted result

Group	Value (mean), nmol BCE/L	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	-2.4	—
Change from week 0 to week 56	-3.7	—
Change from week 56 to week 82	-2.8	—
PlaceboChange from week 0 to week 30	-3.2	—
Change from week 0 to week 56	-2.9	—
Change from week 56 to week 82	-4.6	—

Secondary/registry result

Change in P1NP

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

P1NP

change from baseline, descriptive

Posted result

Group	Value (mean), ng/mL	95% CI
Liraglutide 3.0 mgChange from week 0 to week 30	-35	—
Change from week 0 to week 56	-55	—
Change from week 56 to week 82	-30	—
PlaceboChange from week 0 to week 30	-30	—
Change from week 0 to week 56	-63	—
Change from week 56 to week 82	-47	—

Secondary/registry result

Change in Pubertal Status

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide 3.0 mgWeek 0: Breast development (for female)	2	—
Week 0: Breast development (for female)	6	—
Week 0: Breast development (for female)	23	—
Week 0: Breast development (for female)	40	—
Week 30: Breast development (for female)	1	—
Week 30: Breast development (for female)	4	—
Week 30: Breast development (for female)	22	—
Week 30: Breast development (for female)	39	—
Week 56: Breast development (for female)	0	—
Week 56: Breast development (for female)	2	—
Week 56: Breast development (for female)	14	—
Week 56: Breast development (for female)	41	—
Week 82: Breast development (for female)	0	—
Week 82: Breast development (for female)	0	—
Week 82: Breast development (for female)	7	—
Week 82: Breast development (for female)	46	—
Week 0: Pubic hair development (for female)	2	—
Week 0: Pubic hair development (for female)	6	—
Week 0: Pubic hair development (for female)	22	—
Week 0: Pubic hair development (for female)	41	—
Week 30: Pubic hair development (for female)	1	—
Week 30: Pubic hair development (for female)	4	—
Week 30: Pubic hair development (for female)	20	—
Week 30: Pubic hair development (for female)	41	—
Week 56: Pubic hair development (for female)	1	—
Week 56: Pubic hair development (for female)	2	—
Week 56: Pubic hair development (for female)	13	—
Week 56: Pubic hair development (for female)	41	—
Week 82: Pubic hair development (for female)	0	—
Week 82: Pubic hair development (for female)	1	—
Week 82: Pubic hair development (for female)	7	—
Week 82: Pubic hair development (for female)	45	—
Week 0: penis development (male)	4	—
Week 0: penis development (male)	11	—
Week 0: penis development (male)	16	—
Week 0: penis development (male)	23	—
Week 30: penis development (male)	1	—
Week 30: penis development (male)	11	—
Week 30: penis development (male)	14	—
Week 30: penis development (male)	25	—
Week 56: penis development (male)	1	—
Week 56: penis development (male)	6	—
Week 56: penis development (male)	15	—
Week 56: penis development (male)	26	—
Week 82: penis development (male)	0	—
Week 82: penis development (male)	3	—
Week 82: penis development (male)	11	—
Week 82: penis development (male)	31	—
Week 0: Pubic hair development (male)	6	—
Week 0: Pubic hair development (male)	8	—
Week 0: Pubic hair development (male)	19	—
Week 0: Pubic hair development (male)	21	—
Week 30: Pubic hair development (male)	1	—
Week 30: Pubic hair development (male)	10	—
Week 30: Pubic hair development (male)	15	—
Week 30: Pubic hair development (male)	24	—
Week 56: Pubic hair development (male)	1	—
Week 56: Pubic hair development (male)	7	—
Week 56: Pubic hair development (male)	15	—
Week 56: Pubic hair development (male)	24	—
Week 82: Pubic hair development (male)	0	—
Week 82: Pubic hair development (male)	3	—
Week 82: Pubic hair development (male)	10	—
Week 82: Pubic hair development (male)	30	—
PlaceboWeek 0: Breast development (for female)	1	—
Week 0: Breast development (for female)	8	—
Week 0: Breast development (for female)	30	—
Week 0: Breast development (for female)	39	—
Week 30: Breast development (for female)	0	—
Week 30: Breast development (for female)	6	—
Week 30: Breast development (for female)	25	—
Week 30: Breast development (for female)	43	—
Week 56: Breast development (for female)	0	—
Week 56: Breast development (for female)	2	—
Week 56: Breast development (for female)	20	—
Week 56: Breast development (for female)	41	—
Week 82: Breast development (for female)	0	—
Week 82: Breast development (for female)	2	—
Week 82: Breast development (for female)	13	—
Week 82: Breast development (for female)	46	—
Week 0: Pubic hair development (for female)	3	—
Week 0: Pubic hair development (for female)	5	—
Week 0: Pubic hair development (for female)	26	—
Week 0: Pubic hair development (for female)	44	—
Week 30: Pubic hair development (for female)	0	—
Week 30: Pubic hair development (for female)	4	—
Week 30: Pubic hair development (for female)	25	—
Week 30: Pubic hair development (for female)	45	—
Week 56: Pubic hair development (for female)	0	—
Week 56: Pubic hair development (for female)	2	—
Week 56: Pubic hair development (for female)	21	—
Week 56: Pubic hair development (for female)	40	—
Week 82: Pubic hair development (for female)	0	—
Week 82: Pubic hair development (for female)	2	—
Week 82: Pubic hair development (for female)	14	—
Week 82: Pubic hair development (for female)	45	—
Week 0: penis development (male)	7	—
Week 0: penis development (male)	8	—
Week 0: penis development (male)	14	—
Week 0: penis development (male)	19	—
Week 30: penis development (male)	2	—
Week 30: penis development (male)	7	—
Week 30: penis development (male)	11	—
Week 30: penis development (male)	25	—
Week 56: penis development (male)	0	—
Week 56: penis development (male)	6	—
Week 56: penis development (male)	6	—
Week 56: penis development (male)	29	—
Week 82: penis development (male)	0	—
Week 82: penis development (male)	3	—
Week 82: penis development (male)	6	—
Week 82: penis development (male)	29	—
Week 0: Pubic hair development (male)	9	—
Week 0: Pubic hair development (male)	5	—
Week 0: Pubic hair development (male)	13	—
Week 0: Pubic hair development (male)	21	—
Week 30: Pubic hair development (male)	3	—
Week 30: Pubic hair development (male)	7	—
Week 30: Pubic hair development (male)	9	—
Week 30: Pubic hair development (male)	26	—
Week 56: Pubic hair development (male)	0	—
Week 56: Pubic hair development (male)	6	—
Week 56: Pubic hair development (male)	7	—
Week 56: Pubic hair development (male)	28	—
Week 82: Pubic hair development (male)	0	—
Week 82: Pubic hair development (male)	2	—
Week 82: Pubic hair development (male)	8	—
Week 82: Pubic hair development (male)	28	—

Secondary/protocol endpoint

Change in Nutritional Compliance

Time frame:Week 0, week 30 and week 56

change from baseline, improvement

Secondary/protocol endpoint

Change in Hormone Level: DHEAS

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Hormone Level: LH and FSH

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, descriptive

Secondary/protocol endpoint

Change in Hormone Level: Estradiol (Females)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Hormone Level: Testosterone (Males)

Time frame:Week 0, week 30, week 56 and week 82

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Change in NTX1

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, improvement

Secondary/protocol endpoint

Change in Alkaline Phosphatase (Bone)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, improvement

Secondary/protocol endpoint

Change in Pubertal Status

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

categorical status, descriptive

Other (unclassified)

8 endpoints

Secondary/protocol endpoint

Change in Haematology: Haemoglobin

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Biochemistry: Creatinine and Bilirubin (Total)

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, descriptive

Secondary/protocol endpoint

Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Biochemistry: Albumin

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Biochemistry: CEA

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Hormone Level: IGF-1 and Cortisol

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in CTX1

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in P1NP

Time frame:(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

change from baseline, improvement

Publications (2)

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

Evaluating potential predictors of weight loss response to liraglutide in adolescents with obesity: A post hoc analysis of the randomized, placebo-controlled SCALE Teens trial.
Pediatric obesity2023 Sep (month)PMID37264767doi:10.1111/ijpo.13061via clinicaltrials gov reference derived + pubmed nct search
A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity.
The New England journal of medicine2020 May 28PMID32233338doi:10.1056/NEJMoa1916038via CT.gov reference + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.