GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT02453711

CompletedPhase 2Results posted

Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus

Lead sponsor

Novo Nordisk A/S

Assets

Liraglutide / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

957

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•Body weight, % 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 IDNCT02453711

Org study IDNN9536-4153

Secondary ID2014-001540-38

Secondary IDU1111-1155-4660WHO

Timeline

Milestones

Study first posted2015-05-25estimated

Study start2015-10-01actual

Primary completion2017-03-30actual

Study completion2017-04-12actual

Last update posted2020-04-17actual

Results first posted2020-04-17actual

Assets

Investigational agents

Liraglutide Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Eligibility 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 18 years or older at the time of signing inform consent - Body mass index (BMI) equal or above 30.0 kg/m^2 at the screening visit - At least one unsuccessful weight loss attempt per investigator judgement Exclusion Criteria: - A HbA1c (glycosylated haemoglobin) equal to or above 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus - Treatment with glucose lowering agent(s) within 90 days before screening - Screening calcitonin equal to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 - History of pancreatitis (acute or chronic) - Obesity induced by endocrine disorders (e.g. Cushing Syndrome) - Treatment with any medication within 90 days before screening that based on investigator's judgement may cause significant weight change - Previous surgical treatment for obesity (liposuction and/or abdominoplasty performed 1 year before screening is allowed) - History of major depressive disorder within 2 years before randomisation - Any lifetime history of a suicidal attempt - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)

Endpoints (74)

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

Glycemic / diabetes

Patient-reported / QoL

Other clinical outcomes

Renal / kidney

Other (unclassified)

Weight & body composition

14 endpoints

Primary/registry result

Relative Change in Body Weight (%)

Time frame:Week 0, Week 52

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percentage (%) of body weight	95% CI
Semaglutide 0.05 mg	-5.99	—
Semaglutide 0.1 mg	-8.62	—
Semaglutide 0.2 mg	-11.60	—
Semaglutide 0.3 mg	-11.17	—
Semaglutide 0.4 mg	-13.84	—
Semaglutide 0.3 mg (Fast Escalation)	-11.38	—
Semaglutide 0.4 mg (Fast Escalation)	-16.29	—
Liraglutide 3.0 mg	-7.76	—
Placebo Pool	-2.29	—

Treatment difference (%-points)-3.7095% CI-6.55 – -0.85p=0.0055ANCOVA

Treatment difference (%-points)-6.3295% CI-9.16 – -3.49p<0.0001ANCOVA

Treatment difference (%-points)-9.3195% CI-12.15 – -6.46p<0.0001ANCOVA

Treatment difference (%-points)-8.8895% CI-11.72 – -6.03p<0.0001ANCOVA

Treatment difference (%-points)-11.5595% CI-14.38 – -8.72p<0.0001ANCOVA

Primary/protocol endpoint

Relative Change in Body Weight (%)

Time frame:Week 0, Week 52

Body weight, % change

percent change from baseline, improvement

Secondary/registry result

Participants With Weight Loss of ≥5% of Baseline Body Weight

Time frame:Week 52

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage (%) of participants	95% CI
Semaglutide 0.05 mg	53.50	—
Semaglutide 0.1 mg	67.49	—
Semaglutide 0.2 mg	74.91	—
Semaglutide 0.3 mg	80.52	—
Semaglutide 0.4 mg	82.52	—
Semaglutide 0.3 mg (Fast Escalation)	72.19	—
Semaglutide 0.4 mg (Fast Escalation)	89.58	—
Liraglutide 3.0 mg	66.12	—
Placebo Pool	22.87	—

Secondary/registry result

Participants With Weight Loss of ≥10% of Baseline Body Weight

Time frame:Week 52

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage (%) of participants	95% CI
Semaglutide 0.05 mg	18.94	—
Semaglutide 0.1 mg	36.57	—
Semaglutide 0.2 mg	55.95	—
Semaglutide 0.3 mg	57.76	—
Semaglutide 0.4 mg	64.61	—
Semaglutide 0.3 mg (Fast Escalation)	58.45	—
Semaglutide 0.4 mg (Fast Escalation)	71.91	—
Liraglutide 3.0 mg	33.98	—
Placebo Pool	10.08	—

Secondary/registry result

Change in Body Weight (kg)

Time frame:Week 0, Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Kilogram (kg)	95% CI
Semaglutide 0.05 mg	-6.66	—
Semaglutide 0.1 mg	-9.34	—
Semaglutide 0.2 mg	-12.30	—
Semaglutide 0.3 mg	-12.45	—
Semaglutide 0.4 mg	-15.15	—
Semaglutide 0.3 mg (Fast Escalation)	-12.54	—
Semaglutide 0.4 mg (Fast Escalation)	-17.36	—
Liraglutide 3.0 mg	-8.47	—
Placebo Pool	-2.48	—

Secondary/registry result

Change in Waist Circumference

Time frame:Week 0, Week 52

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Centimetre (cm)	95% CI
Semaglutide 0.05 mg	-6.11	—
Semaglutide 0.1 mg	-8.75	—
Semaglutide 0.2 mg	-11.02	—
Semaglutide 0.3 mg	-10.91	—
Semaglutide 0.4 mg	-12.31	—
Semaglutide 0.3 mg (Fast Escalation)	-11.06	—
Semaglutide 0.4 mg (Fast Escalation)	-14.88	—
Liraglutide 3.0 mg	-8.35	—
Placebo Pool	-3.47	—

Secondary/registry result

Change in Waist to Hip Circumference Ratio

Time frame:Week 0, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Waist to hip circumference ratio	95% CI
Semaglutide 0.05 mg	-0.01	—
Semaglutide 0.1 mg	-0.02	—
Semaglutide 0.2 mg	-0.02	—
Semaglutide 0.3 mg	-0.03	—
Semaglutide 0.4 mg	-0.02	—
Semaglutide 0.3 mg (Fast Escalation)	-0.02	—
Semaglutide 0.4 mg (Fast Escalation)	-0.03	—
Liraglutide 3.0 mg	-0.02	—
Placebo Pool	-0.01	—

Secondary/registry result

Change in BMI

Time frame:Week 0, Week 52

BMI, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Kilogram per square meter (kg/m^2)	95% CI
Semaglutide 0.05 mg	-2.37	—
Semaglutide 0.1 mg	-3.36	—
Semaglutide 0.2 mg	-4.38	—
Semaglutide 0.3 mg	-4.40	—
Semaglutide 0.4 mg	-5.40	—
Semaglutide 0.3 mg (Fast Escalation)	-4.48	—
Semaglutide 0.4 mg (Fast Escalation)	-6.21	—
Liraglutide 3.0 mg	-3.03	—
Placebo Pool	-0.88	—

Secondary/protocol endpoint

Participants With Weight Loss of ≥5% of Baseline Body Weight

Time frame:Week 52

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Participants With Weight Loss of ≥10% of Baseline Body Weight

Time frame:Week 52

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in Body Weight (kg)

Time frame:Week 0, Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Week 0, Week 52

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist to Hip Circumference Ratio

Time frame:Week 0, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in BMI

Time frame:Week 0, Week 52

BMI, change

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Secondary/registry result

Change in HbA1c

Time frame:Week 0, Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage of HbA1c	95% CI
Semaglutide 0.05 mg	-0.13	—
Semaglutide 0.1 mg	-0.21	—
Semaglutide 0.2 mg	-0.28	—
Semaglutide 0.3 mg	-0.23	—
Semaglutide 0.4 mg	-0.29	—
Semaglutide 0.3 mg (Fast Escalation)	-0.25	—
Semaglutide 0.4 mg (Fast Escalation)	-0.34	—
Liraglutide 3.0 mg	-0.21	—
Placebo Pool	-0.01	—

Secondary/registry result

Change in FPG

Time frame:Week 0, Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), Millimoles per litre (mmol/L)	95% CI
Semaglutide 0.05 mg	-0.29	—
Semaglutide 0.1 mg	-0.35	—
Semaglutide 0.2 mg	-0.40	—
Semaglutide 0.3 mg	-0.39	—
Semaglutide 0.4 mg	-0.43	—
Semaglutide 0.3 mg (Fast Escalation)	-0.38	—
Semaglutide 0.4 mg (Fast Escalation)	-0.51	—
Liraglutide 3.0 mg	-0.35	—
Placebo Pool	0.01	—

Secondary/registry result

Change in Glycaemic Category (Normoglycaemia, Pre-diabetes, T2D)

Time frame:Week 0, Week 52

categorical status, improvement

Secondary/protocol endpoint

Change in HbA1c

Time frame:Week 0, Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in FPG

Time frame:Week 0, Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Glycaemic Category (Normoglycaemia, Pre-diabetes, T2D)

Time frame:Week 0, Week 52

categorical status, improvement

Renal / kidney

2 endpoints

Secondary/registry result/low confidence

Change in Biochemistry: Creatinine and Bilirubin (Total)

Time frame:Week 0, week 52

change from baseline, descriptive

Posted result

Group	Value (mean), Micromole/litre (umol/L)	95% CI
Semaglutide 0.05 mgCreatinine	-1.14	—
Bilirubin (total)	0.30	—
Semaglutide 0.1 mgCreatinine	-0.85	—
Bilirubin (total)	1.12	—
Semaglutide 0.2 mgCreatinine	-1.09	—
Bilirubin (total)	1.59	—
Semaglutide 0.3 mgCreatinine	0.76	—
Bilirubin (total)	1.33	—
Semaglutide 0.4 mgCreatinine	1.48	—
Bilirubin (total)	1.23	—
Semaglutide 0.3 mg (Fast Escalation)Creatinine	1.05	—
Bilirubin (total)	1.02	—
Semaglutide 0.4 mg (Fast Escalation)Creatinine	-2.10	—
Bilirubin (total)	1.67	—
Liraglutide 3.0 mgCreatinine	-0.81	—
Bilirubin (total)	1.02	—
Placebo PoolCreatinine	0.28	—
Bilirubin (total)	1.09	—

Secondary/protocol endpoint/low confidence

Change in Biochemistry: Creatinine and Bilirubin (Total)

Time frame:Week 0, week 52

change from baseline, improvement

Cardiometabolic biomarkers

10 endpoints

Secondary/registry result

Change in SBP

Time frame:Week 0, Week 52

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (least_squares_mean), Millimeters of mercury (mmHg)	95% CI
Semaglutide 0.05 mg	-4.46	—
Semaglutide 0.1 mg	-5.76	—
Semaglutide 0.2 mg	-6.26	—
Semaglutide 0.3 mg	-6.41	—
Semaglutide 0.4 mg	-5.81	—
Semaglutide 0.3 mg (Fast Escalation)	-6.07	—
Semaglutide 0.4 mg (Fast Escalation)	-10.26	—
Liraglutide 3.0 mg	-5.45	—
Placebo Pool	-1.58	—

Secondary/registry result

Change in DBP

Time frame:Week 0, Week 52

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (least_squares_mean), Millimeters of mercury (mmHg)	95% CI
Semaglutide 0.05 mg	-2.55	—
Semaglutide 0.1 mg	-2.65	—
Semaglutide 0.2 mg	-4.09	—
Semaglutide 0.3 mg	-2.98	—
Semaglutide 0.4 mg	-3.61	—
Semaglutide 0.3 mg (Fast Escalation)	-2.20	—
Semaglutide 0.4 mg (Fast Escalation)	-5.52	—
Liraglutide 3.0 mg	-2.70	—
Placebo Pool	-1.50	—

Secondary/registry result

Change in Lipids (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides and FFA)

Time frame:Week 0, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Millimoles per litre (mmol/L)	95% CI
Semaglutide 0.05 mgTotal cholesterol	0.96	—
LDL cholesterol	0.97	—
HDL cholesterol	0.99	—
VLDL cholesterol	0.90	—
Triglycerides	0.89	—
Semaglutide 0.1 mgTotal cholesterol	0.95	—
LDL cholesterol	0.93	—
HDL cholesterol	1.02	—
VLDL cholesterol	0.89	—
Triglycerides	0.88	—
Semaglutide 0.2 mgTotal cholesterol	0.93	—
LDL cholesterol	0.93	—
HDL cholesterol	1.02	—
VLDL cholesterol	0.81	—
Triglycerides	0.81	—
Semaglutide 0.3 mgTotal cholesterol	0.93	—
LDL cholesterol	0.92	—
HDL cholesterol	1.02	—
VLDL cholesterol	0.85	—
Triglycerides	0.85	—
Semaglutide 0.4 mgTotal cholesterol	0.93	—
LDL cholesterol	0.93	—
HDL cholesterol	1.00	—
VLDL cholesterol	0.81	—
Triglycerides	0.80	—
Semaglutide 0.3 mg (Fast Escalation)Total cholesterol	0.93	—
LDL cholesterol	0.92	—
HDL cholesterol	1.00	—
VLDL cholesterol	0.87	—
Triglycerides	0.87	—
Semaglutide 0.4 mg (Fast Escalation)Total cholesterol	0.92	—
LDL cholesterol	0.91	—
HDL cholesterol	1.01	—
VLDL cholesterol	0.81	—
Triglycerides	0.80	—
Liraglutide 3.0 mgTotal cholesterol	0.96	—
LDL cholesterol	0.95	—
HDL cholesterol	1.00	—
VLDL cholesterol	0.91	—
Triglycerides	0.90	—
Placebo PoolTotal cholesterol	0.97	—
LDL cholesterol	0.97	—
HDL cholesterol	1.00	—
VLDL cholesterol	0.95	—
Triglycerides	0.95	—

Secondary/registry result

Change in hsCRP

Time frame:Week 0, Week 52

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Posted result

Group	Value (least_squares_mean), Milligrams per decilitre (mg/dL)	95% CI
Semaglutide 0.05 mg	0.71	—
Semaglutide 0.1 mg	0.65	—
Semaglutide 0.2 mg	0.57	—
Semaglutide 0.3 mg	0.66	—
Semaglutide 0.4 mg	0.54	—
Semaglutide 0.3 mg (Fast Escalation)	0.58	—
Semaglutide 0.4 mg (Fast Escalation)	0.44	—
Liraglutide 3.0 mg	0.72	—
Placebo Pool	0.82	—

Secondary/registry result

Change in Pulse

Time frame:Week 0, week 52

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Beats per minute	95% CI
Semaglutide 0.05 mg	-0.33	—
Semaglutide 0.1 mg	3.46	—
Semaglutide 0.2 mg	1.88	—
Semaglutide 0.3 mg	2.38	—
Semaglutide 0.4 mg	2.54	—
Semaglutide 0.3 mg (Fast Escalation)	2.34	—
Semaglutide 0.4 mg (Fast Escalation)	2.15	—
Liraglutide 3.0 mg	2.63	—
Placebo Pool	-0.86	—

Secondary/protocol endpoint

Change in SBP

Time frame:Week 0, Week 52

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in DBP

Time frame:Week 0, Week 52

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change in Lipids (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides and FFA)

Time frame:Week 0, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in hsCRP

Time frame:Week 0, Week 52

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in Pulse

Time frame:Week 0, week 52

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

6 endpoints

Secondary/registry result

Change in IWQoL Lite

Time frame:Week 0, Week 52

IWQOL-Lite total

change from baseline, improvement

Secondary/registry result

Change in SF-36

Time frame:Week 0, Week 52

SF-36 total

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Semaglutide 0.05 mgBodily pain	1.85	—
General health	2.03	—
Mental health	0.42	—
Physical functioning	6.00	—
Role-emotional	3.31	—
Role-physical	3.45	—
Social functioning	0.81	—
Vitality	1.73	—
Physical component summary	4.16	—
Mental component summary	0.25	—
Semaglutide 0.1 mgBodily pain	3.01	—
General health	2.51	—
Mental health	0.24	—
Physical functioning	4.67	—
Role-emotional	-1.69	—
Role-physical	4.37	—
Social functioning	0.71	—
Vitality	5.16	—
Physical component summary	5.51	—
Mental component summary	-1.15	—
Semaglutide 0.2 mgBodily pain	4.27	—
General health	4.17	—
Mental health	2.82	—
Physical functioning	6.52	—
Role-emotional	1.17	—
Role-physical	7.35	—
Social functioning	1.36	—
Vitality	8.90	—
Physical component summary	7.14	—
Mental component summary	1.45	—
Semaglutide 0.3 mgBodily pain	3.82	—
General health	1.20	—
Mental health	-0.55	—
Physical functioning	4.75	—
Role-emotional	1.25	—
Role-physical	3.40	—
Social functioning	-0.88	—
Vitality	3.22	—
Physical component summary	4.70	—
Mental component summary	-1.10	—
Semaglutide 0.4 mgBodily pain	5.16	—
General health	5.85	—
Mental health	2.47	—
Physical functioning	8.74	—
Role-emotional	2.24	—
Role-physical	4.53	—
Social functioning	2.81	—
Vitality	9.37	—
Physical component summary	7.67	—
Mental component summary	1.97	—
Semaglutide 0.3 mg (Fast Escalation)Bodily pain	1.88	—
General health	5.85	—
Mental health	1.02	—
Physical functioning	7.27	—
Role-emotional	0.18	—
Role-physical	7.12	—
Social functioning	2.23	—
Vitality	5.96	—
Physical component summary	7.54	—
Mental component summary	-0.25	—
Semaglutide 0.4 mg (Fast Escalation)Bodily pain	5.11	—
General health	4.81	—
Mental health	1.64	—
Physical functioning	7.28	—
Role-emotional	2.11	—
Role-physical	5.51	—
Social functioning	-0.91	—
Vitality	7.02	—
Physical component summary	7.28	—
Mental component summary	0.20	—
Liraglutide 3.0 mgBodily pain	2.48	—
General health	3.95	—
Mental health	1.91	—
Physical functioning	6.79	—
Role-emotional	0.25	—
Role-physical	5.37	—
Social functioning	0.35	—
Vitality	4.83	—
Physical component summary	6.21	—
Mental component summary	-0.26	—
Placebo PoolBodily pain	1.21	—
General health	1.39	—
Mental health	-0.38	—
Physical functioning	2.28	—
Role-emotional	0.63	—
Role-physical	1.52	—
Social functioning	-0.29	—
Vitality	3.38	—
Physical component summary	2.29	—
Mental component summary	-0.05	—

Secondary/registry result

Change in Mental Health Assessed by PHQ-9

Time frame:Week 0, week 52

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Semaglutide 0.05 mgWeek 0	2.5	—
Week 52	1.5	—
Semaglutide 0.1 mgWeek 0	1.7	—
Week 52	1.1	—
Semaglutide 0.2 mgWeek 0	2.1	—
Week 52	1.3	—
Semaglutide 0.3 mgWeek 0	1.5	—
Week 52	1.1	—
Semaglutide 0.4 mgWeek 0	2.5	—
Week 52	1.0	—
Semaglutide 0.3 mg (Fast Escalation)Week 0	1.7	—
Week 52	1.1	—
Semaglutide 0.4 mg (Fast Escalation)Week 0	2.0	—
Week 52	0.9	—
Liraglutide 3.0 mgWeek 0	2.0	—
Week 52	1.3	—
Placebo PoolWeek 0	2.5	—
Week 52	1.7	—

Secondary/protocol endpoint

Change in IWQoL Lite

Time frame:Week 0, Week 52

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36

Time frame:Week 0, Week 52

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change in Mental Health Assessed by PHQ-9

Time frame:Week 0, week 52

change from baseline, improvement

Safety / tolerability / PK

31 endpoints

Secondary/registry result

Number of AEs During the Trial

Time frame:Week 0-59

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Semaglutide 0.05 mg	547	—
Semaglutide 0.1 mg	730	—
Semaglutide 0.2 mg	738	—
Semaglutide 0.3 mg	587	—
Semaglutide 0.4 mg	775	—
Semaglutide 0.3 mg (Fast Escalation)	737	—
Semaglutide 0.4 mg (Fast Escalation)	681	—
Liraglutide 3.0 mg	612	—
Placebo Pool	650	—

Secondary/registry result

Number of Hypoglycaemic Episodes During the Trial

Time frame:Week 0-59

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), Episodes	95% CI
Semaglutide 0.05 mg	1	—
Semaglutide 0.1 mg	6	—
Semaglutide 0.2 mg	4	—
Semaglutide 0.3 mg	8	—
Semaglutide 0.4 mg	10	—
Semaglutide 0.3 mg (Fast Escalation)	20	—
Semaglutide 0.4 mg (Fast Escalation)	16	—
Liraglutide 3.0 mg	4	—
Placebo Pool	18	—

Secondary/registry result

Number of New and Ongoing Nausea, Vomiting, Diarrhoea, and Constipation Events by Week

Time frame:Week 0-59

event count, event

componentsNausea, Vomiting, Diarrhea

Posted result

Group	Value (number), Events	95% CI
Semaglutide 0.05 mgNausea	41	—
Vomiting	10	—
Diarrhoea	29	—
Constipation	15	—
Semaglutide 0.1 mgNausea	80	—
Vomiting	29	—
Diarrhoea	37	—
Constipation	27	—
Semaglutide 0.2 mgNausea	74	—
Vomiting	41	—
Diarrhoea	61	—
Constipation	33	—
Semaglutide 0.3 mgNausea	69	—
Vomiting	18	—
Diarrhoea	54	—
Constipation	25	—
Semaglutide 0.4 mgNausea	94	—
Vomiting	35	—
Diarrhoea	63	—
Constipation	35	—
Semaglutide 0.3 mg (Fast Escalation)Nausea	106	—
Vomiting	32	—
Diarrhoea	54	—
Constipation	23	—
Semaglutide 0.4 mg (Fast Escalation)Nausea	97	—
Vomiting	47	—
Diarrhoea	49	—
Constipation	34	—
Liraglutide 3.0 mgNausea	89	—
Vomiting	17	—
Diarrhoea	46	—
Constipation	30	—
Placebo PoolNausea	30	—
Vomiting	6	—
Diarrhoea	23	—
Constipation	7	—

Secondary/registry result

Nausea: Individual Scores of Nausea Questionnaire and Severity by NRS Score

Time frame:Week 52

Nausea

descriptive

Posted result

Group	Value (number), Events	95% CI
Semaglutide 0.1 mgDuration of nausea:<30 min	0	—
Duration of nausea: 30 min-2 hr	0	—
Duration of nausea: 2-4 hr	0	—
Duration of nausea: 4-8 hr	1	—
Duration of nausea: >8 hr	0	—
Latest injection to onset time: 0-3 hr	0	—
Latest injection to onset time: 3-6 hr	0	—
Latest injection to onset time: 6-12 hr	1	—
Latest injection to onset time: 12-18 hr	0	—
Latest injection to onset time: >18 hr	0	—
Last food intake to onset time: 0-1 hr	0	—
Last food intake to onset time: 1-2 hr	1	—
Last food intake to onset time: 2-3 hr	0	—
Last food intake to onset time: 3-6 hr	0	—
Last food intake to onset time: >6 hr	0	—
Nausea accompanied by vomiting (Yes)	0	—
Nausea accompanied by vomiting (No)	1	—
Severity of nausea: 0	0	—
Severity of nausea: 1	0	—
Severity of nausea: 2	0	—
Severity of nausea: 3	0	—
Severity of nausea: 4	0	—
Severity of nausea: 5	1	—
Severity of nausea: 6	0	—
Severity of nausea: 7	0	—
Severity of nausea: 8	0	—
Severity of nausea: 9	0	—
Severity of nausea: 10	0	—
Semaglutide 0.2 mgDuration of nausea:<30 min	1	—
Duration of nausea: 30 min-2 hr	0	—
Duration of nausea: 2-4 hr	0	—
Duration of nausea: 4-8 hr	0	—
Duration of nausea: >8 hr	0	—
Latest injection to onset time: 0-3 hr	0	—
Latest injection to onset time: 3-6 hr	0	—
Latest injection to onset time: 6-12 hr	0	—
Latest injection to onset time: 12-18 hr	1	—
Latest injection to onset time: >18 hr	0	—
Last food intake to onset time: 0-1 hr	1	—
Last food intake to onset time: 1-2 hr	0	—
Last food intake to onset time: 2-3 hr	0	—
Last food intake to onset time: 3-6 hr	0	—
Last food intake to onset time: >6 hr	0	—
Nausea accompanied by vomiting (Yes)	0	—
Nausea accompanied by vomiting (No)	1	—
Severity of nausea: 0	0	—
Severity of nausea: 1	0	—
Severity of nausea: 2	0	—
Severity of nausea: 3	0	—
Severity of nausea: 4	1	—
Severity of nausea: 5	0	—
Severity of nausea: 6	0	—
Severity of nausea: 7	0	—
Severity of nausea: 8	0	—
Severity of nausea: 9	0	—
Severity of nausea: 10	0	—

Secondary/registry result

Change in ECG

Time frame:Week 0, week 52

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 0.05 mgWeek: 0	70	—
Week: 0	33	—
Week: 0	0	—
Week: 52	57	—
Week: 52	25	—
Week: 52	0	—
Semaglutide 0.1 mgWeek: 0	69	—
Week: 0	31	—
Week: 0	2	—
Week: 52	73	—
Week: 52	18	—
Week: 52	0	—
Semaglutide 0.2 mgWeek: 0	74	—
Week: 0	29	—
Week: 0	0	—
Week: 52	67	—
Week: 52	18	—
Week: 52	2	—
Semaglutide 0.3 mgWeek: 0	62	—
Week: 0	41	—
Week: 0	0	—
Week: 52	58	—
Week: 52	31	—
Week: 52	0	—
Semaglutide 0.4 mgWeek: 0	62	—
Week: 0	38	—
Week: 0	2	—
Week: 52	57	—
Week: 52	29	—
Week: 52	1	—
Semaglutide 0.3 mg (Fast Escalation)Week: 0	70	—
Week: 0	32	—
Week: 0	0	—
Week: 52	55	—
Week: 52	21	—
Week: 52	1	—
Semaglutide 0.4 mg (Fast Escalation)Week: 0	74	—
Week: 0	27	—
Week: 0	2	—
Week: 52	64	—
Week: 52	28	—
Week: 52	0	—
Liraglutide 3.0 mgWeek: 0	68	—
Week: 0	35	—
Week: 0	0	—
Week: 52	59	—
Week: 52	26	—
Week: 52	1	—
Placebo PoolWeek: 0	85	—
Week: 0	51	—
Week: 0	0	—
Week: 52	66	—
Week: 52	40	—
Week: 52	0	—

Secondary/registry result

Change in Haematology: Haemoglobin

Time frame:Week 0, week 52

change from baseline, descriptive

Posted result

Group	Value (mean), Millimoles per litre (mmol/L)	95% CI
Semaglutide 0.05 mg	0.01	—
Semaglutide 0.1 mg	-0.08	—
Semaglutide 0.2 mg	-0.02	—
Semaglutide 0.3 mg	-0.07	—
Semaglutide 0.4 mg	0.00	—
Semaglutide 0.3 mg (Fast Escalation)	-0.07	—
Semaglutide 0.4 mg (Fast Escalation)	0.02	—
Liraglutide 3.0 mg	0.11	—
Placebo Pool	-0.01	—

Secondary/registry result

Change in Haematology: Haematocrit

Time frame:Week 0, week 52

change from baseline, descriptive

Posted result

Group	Value (mean), Percentage of red blood cells	95% CI
Semaglutide 0.05 mg	-0.25	—
Semaglutide 0.1 mg	-0.58	—
Semaglutide 0.2 mg	-0.42	—
Semaglutide 0.3 mg	-0.49	—
Semaglutide 0.4 mg	-0.31	—
Semaglutide 0.3 mg (Fast Escalation)	-0.68	—
Semaglutide 0.4 mg (Fast Escalation)	-0.15	—
Liraglutide 3.0 mg	0.26	—
Placebo Pool	0.26	—

Secondary/registry result

Change in Haematology: Thrombocytes, Leucocytes and Differential Count

Time frame:Week 0, week 52

change from baseline, descriptive

componentsthrombocytes, leucocytes, eosinophils, neutrophils, basophils, monocytes, lymphocytes

Posted result

Group	Value (mean), 10^9 cells/litre (L)	95% CI
Semaglutide 0.05 mgThrombocytes	-2.08	—
Leucocytes	-0.47	—
Eosinophils	0.02	—
Neutrophils	-0.36	—
Basophils	0.00	—
Monocytes	-0.04	—
Lymphocytes	-0.10	—
Semaglutide 0.1 mgThrombocytes	2.95	—
Leucocytes	-0.24	—
Eosinophils	0.02	—
Neutrophils	-0.07	—
Basophils	-0.00	—
Monocytes	-0.04	—
Lymphocytes	-0.16	—
Semaglutide 0.2 mgThrombocytes	-8.17	—
Leucocytes	-0.23	—
Eosinophils	-0.01	—
Neutrophils	-0.05	—
Basophils	-0.00	—
Monocytes	0.01	—
Lymphocytes	-0.17	—
Semaglutide 0.3 mgThrombocytes	2.79	—
Leucocytes	-0.50	—
Eosinophils	-0.02	—
Neutrophils	-0.22	—
Basophils	-0.01	—
Monocytes	-0.02	—
Lymphocytes	-0.24	—
Semaglutide 0.4 mgThrombocytes	-0.52	—
Leucocytes	-0.68	—
Eosinophils	0.00	—
Neutrophils	-0.51	—
Basophils	-0.00	—
Monocytes	-0.02	—
Lymphocytes	-0.15	—
Semaglutide 0.3 mg (Fast Escalation)Thrombocytes	-5.76	—
Leucocytes	-0.66	—
Eosinophils	0.01	—
Neutrophils	-0.57	—
Basophils	-0.01	—
Monocytes	-0.01	—
Lymphocytes	-0.08	—
Semaglutide 0.4 mg (Fast Escalation)Thrombocytes	-3.32	—
Leucocytes	-0.40	—
Eosinophils	-0.01	—
Neutrophils	-0.23	—
Basophils	0.00	—
Monocytes	-0.03	—
Lymphocytes	-0.14	—
Liraglutide 3.0 mgThrombocytes	4.83	—
Leucocytes	-0.17	—
Eosinophils	0.01	—
Neutrophils	-0.12	—
Basophils	-0.00	—
Monocytes	-0.01	—
Lymphocytes	-0.06	—
Placebo PoolThrombocytes	-6.11	—
Leucocytes	-0.44	—
Eosinophils	0.00	—
Neutrophils	-0.33	—
Basophils	0.00	—
Monocytes	-0.02	—
Lymphocytes	-0.09	—

Secondary/registry result

Change in Haematology: Erythrocytes

Time frame:Week 0, week 52

change from baseline, descriptive

Posted result

Group	Value (mean), 10^12 cells/litre (L)	95% CI
Semaglutide 0.05 mg	-0.01	—
Semaglutide 0.1 mg	-0.06	—
Semaglutide 0.2 mg	-0.03	—
Semaglutide 0.3 mg	-0.04	—
Semaglutide 0.4 mg	-0.01	—
Semaglutide 0.3 mg (Fast Escalation)	-0.04	—
Semaglutide 0.4 mg (Fast Escalation)	-0.01	—
Liraglutide 3.0 mg	0.05	—
Placebo Pool	0.04	—

Secondary/registry result

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

Time frame:Week 0, week 52

change from baseline, descriptive

componentscreatine kinase change, amylase change, lipase change, ALT, change, AST, change, alp change

Posted result

Group	Value (mean), Unit/litre (U/L)	95% CI
Semaglutide 0.05 mgCreatinine kinase	0.53	—
Amylase	3.35	—
Lipase	5.62	—
ALT	-5.82	—
AST	-1.08	—
ALP	-3.42	—
Semaglutide 0.1 mgCreatinine kinase	-44.75	—
Amylase	4.84	—
Lipase	8.83	—
ALT	-5.45	—
AST	-1.99	—
ALP	-3.44	—
Semaglutide 0.2 mgCreatinine kinase	-13.20	—
Amylase	9.20	—
Lipase	17.55	—
ALT	-7.44	—
AST	-2.33	—
ALP	-6.21	—
Semaglutide 0.3 mgCreatinine kinase	-46.34	—
Amylase	7.53	—
Lipase	13.28	—
ALT	-9.15	—
AST	-3.32	—
ALP	-6.70	—
Semaglutide 0.4 mgCreatinine kinase	-29.91	—
Amylase	7.67	—
Lipase	13.33	—
ALT	-3.64	—
AST	-2.07	—
ALP	-4.25	—
Semaglutide 0.3 mg (Fast Escalation)Creatinine kinase	-8.86	—
Amylase	8.39	—
Lipase	14.92	—
ALT	-9.07	—
AST	-1.62	—
ALP	-3.50	—
Semaglutide 0.4 mg (Fast Escalation)Creatinine kinase	-28.08	—
Amylase	7.78	—
Lipase	15.09	—
ALT	-7.17	—
AST	-2.73	—
ALP	-8.20	—
Liraglutide 3.0 mgCreatinine kinase	-3.09	—
Amylase	7.12	—
Lipase	11.86	—
ALT	-2.95	—
AST	-1.48	—
ALP	-0.52	—
Placebo PoolCreatinine kinase	53.36	—
Amylase	3.41	—
Lipase	1.63	—
ALT	-3.03	—
AST	0.00	—
ALP	-1.46	—

Secondary/registry result

Change in Biochemistry: Urea, Sodium, Potassium and Calcium (Total)

Time frame:Week 0, week 52

change from baseline, descriptive

Posted result

Group	Value (mean), Millimole/litre (mmol/L)	95% CI
Semaglutide 0.05 mgUrea	-0.04	—
Sodium	-0.18	—
Potassium	0.01	—
Calcium (total)	0.01	—
Semaglutide 0.1 mgUrea	0.16	—
Sodium	-0.27	—
Potassium	0.01	—
Calcium (total)	-0.01	—
Semaglutide 0.2 mgUrea	-0.01	—
Sodium	-0.40	—
Potassium	-0.00	—
Calcium (total)	0.01	—
Semaglutide 0.3 mgUrea	-0.10	—
Sodium	-0.82	—
Potassium	-0.04	—
Calcium (total)	0.01	—
Semaglutide 0.4 mgUrea	-0.00	—
Sodium	-0.92	—
Potassium	-0.10	—
Calcium (total)	0.00	—
Semaglutide 0.3 mg (Fast Escalation)Urea	-0.06	—
Sodium	-0.76	—
Potassium	0.00	—
Calcium (total)	-0.00	—
Semaglutide 0.4 mg (Fast Escalation)Urea	-0.33	—
Sodium	-0.74	—
Potassium	-0.11	—
Calcium (total)	0.00	—
Liraglutide 3.0 mgUrea	0.03	—
Sodium	-0.37	—
Potassium	-0.02	—
Calcium (total)	0.02	—
Placebo PoolUrea	0.21	—
Sodium	-0.35	—
Potassium	-0.04	—
Calcium (total)	-0.00	—

Secondary/registry result

Change in Biochemistry: Albumin

Time frame:Week 0, week 52

albumin serum

change from baseline, descriptive

Posted result

Group	Value (mean), Gram/decilitre (g/dL)	95% CI
Semaglutide 0.05 mg	0.03	—
Semaglutide 0.1 mg	0.01	—
Semaglutide 0.2 mg	0.07	—
Semaglutide 0.3 mg	0.05	—
Semaglutide 0.4 mg	0.03	—
Semaglutide 0.3 mg (Fast Escalation)	0.01	—
Semaglutide 0.4 mg (Fast Escalation)	0.02	—
Liraglutide 3.0 mg	0.06	—
Placebo Pool	0.04	—

Secondary/registry result

Change in Biochemistry: Calcitonin

Time frame:Week 0, week 52

Thyroid event

change from baseline, descriptive

Posted result

Group	Value (mean), Nanogram/litre (ng/L)	95% CI
Semaglutide 0.05 mg	0.08	—
Semaglutide 0.1 mg	0.03	—
Semaglutide 0.2 mg	0.04	—
Semaglutide 0.3 mg	0.04	—
Semaglutide 0.4 mg	0.17	—
Semaglutide 0.3 mg (Fast Escalation)	-0.01	—
Semaglutide 0.4 mg (Fast Escalation)	0.20	—
Liraglutide 3.0 mg	0.29	—
Placebo Pool	-0.12	—

Secondary/registry result

Change in Biochemistry: TSH

Time frame:Week 0, week 52

Thyroid event

change from baseline, descriptive

Posted result

Group	Value (mean), Milli-international units/litre (mIU/L)	95% CI
Semaglutide 0.05 mg	-0.31	—
Semaglutide 0.1 mg	-0.10	—
Semaglutide 0.2 mg	-0.22	—
Semaglutide 0.3 mg	-0.18	—
Semaglutide 0.4 mg	-0.10	—
Semaglutide 0.3 mg (Fast Escalation)	-0.12	—
Semaglutide 0.4 mg (Fast Escalation)	-0.43	—
Liraglutide 3.0 mg	0.02	—
Placebo Pool	-0.07	—

Secondary/registry result

Change in Mental Health Assessed by C-SSRS

Time frame:Week 0 and Week 4-59

event count, event

componentssuicidal ideation, suicidal behaviour, non suicidal self injurious behaviour

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 0.05 mgWk 0: Suicidal ideation	0	—
Wk 0: Suicidal behaviour	0	—
Wk 0: Non-suicidal self-injurious behaviour	0	—
Wk 4-59: Suicidal ideation	1	—
Wk 4-59: Suicidal behaviour	0	—
Wk 4-59: Non-suicidal self-injurious behaviour	0	—
Semaglutide 0.1 mgWk 0: Suicidal ideation	0	—
Wk 0: Suicidal behaviour	0	—
Wk 0: Non-suicidal self-injurious behaviour	0	—
Wk 4-59: Suicidal ideation	0	—
Wk 4-59: Suicidal behaviour	0	—
Wk 4-59: Non-suicidal self-injurious behaviour	0	—
Semaglutide 0.2 mgWk 0: Suicidal ideation	1	—
Wk 0: Suicidal behaviour	0	—
Wk 0: Non-suicidal self-injurious behaviour	0	—
Wk 4-59: Suicidal ideation	1	—
Wk 4-59: Suicidal behaviour	0	—
Wk 4-59: Non-suicidal self-injurious behaviour	0	—
Semaglutide 0.3 mgWk 0: Suicidal ideation	2	—
Wk 0: Suicidal behaviour	1	—
Wk 0: Non-suicidal self-injurious behaviour	0	—
Wk 4-59: Suicidal ideation	2	—
Wk 4-59: Suicidal behaviour	0	—
Wk 4-59: Non-suicidal self-injurious behaviour	0	—
Semaglutide 0.4 mgWk 0: Suicidal ideation	1	—
Wk 0: Suicidal behaviour	0	—
Wk 0: Non-suicidal self-injurious behaviour	0	—
Wk 4-59: Suicidal ideation	0	—
Wk 4-59: Suicidal behaviour	0	—
Wk 4-59: Non-suicidal self-injurious behaviour	0	—
Semaglutide 0.3 mg (Fast Escalation)Wk 0: Suicidal ideation	0	—
Wk 0: Suicidal behaviour	0	—
Wk 0: Non-suicidal self-injurious behaviour	0	—
Wk 4-59: Suicidal ideation	0	—
Wk 4-59: Suicidal behaviour	0	—
Wk 4-59: Non-suicidal self-injurious behaviour	0	—
Semaglutide 0.4 mg (Fast Escalation)Wk 0: Suicidal ideation	0	—
Wk 0: Suicidal behaviour	0	—
Wk 0: Non-suicidal self-injurious behaviour	0	—
Wk 4-59: Suicidal ideation	0	—
Wk 4-59: Suicidal behaviour	0	—
Wk 4-59: Non-suicidal self-injurious behaviour	0	—
Liraglutide 3.0 mgWk 0: Suicidal ideation	0	—
Wk 0: Suicidal behaviour	0	—
Wk 0: Non-suicidal self-injurious behaviour	0	—
Wk 4-59: Suicidal ideation	2	—
Wk 4-59: Suicidal behaviour	0	—
Wk 4-59: Non-suicidal self-injurious behaviour	0	—
Placebo PoolWk 0: Suicidal ideation	0	—
Wk 0: Suicidal behaviour	0	—
Wk 0: Non-suicidal self-injurious behaviour	0	—
Wk 4-59: Suicidal ideation	1	—
Wk 4-59: Suicidal behaviour	0	—
Wk 4-59: Non-suicidal self-injurious behaviour	0	—

Secondary/registry result

Anti-semaglutide Antibodies During and After Treatment

Time frame:Week 0-52

Immunogenicity (ADA)

descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 0.05 mg	0	—
Semaglutide 0.1 mg	0	—
Semaglutide 0.2 mg	0	—
Semaglutide 0.3 mg	0	—
Semaglutide 0.4 mg	0	—
Semaglutide 0.3 mg (Fast Escalation)	0	—
Semaglutide 0.4 mg (Fast Escalation)	0	—

Secondary/protocol endpoint

Number of AEs During the Trial

Time frame:Week 0-59

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Hypoglycaemic Episodes During the Trial

Time frame:Week 0-59

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of New and Ongoing Nausea, Vomiting, Diarrhoea, and Constipation Events by Week

Time frame:Week 0-59

Diarrhea

event count, event

componentsNausea, Vomiting, Diarrhea

Secondary/protocol endpoint

Nausea: Individual Scores of Nausea Questionnaire and Severity by NRS Score

Time frame:Week 52

Nausea

descriptive

Secondary/protocol endpoint

Change in ECG

Time frame:Week 0, week 52

categorical status, descriptive

Secondary/protocol endpoint

Change in Haematology: Haemoglobin

Time frame:Week 0, week 52

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematology: Haematocrit

Time frame:Week 0, week 52

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematology: Thrombocytes, Leucocytes and Differential Count

Time frame:Week 0, week 52

change from baseline, descriptive

componentsthrombocytes, leucocytes, eosinophils, neutrophils, basophils, monocytes, lymphocytes

Secondary/protocol endpoint

Change in Haematology: Erythrocytes

Time frame:Week 0, week 52

change from baseline, descriptive

Secondary/protocol endpoint

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

Time frame:Week 0, week 52

change from baseline, descriptive

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

Secondary/protocol endpoint

Change in Biochemistry: Urea, Sodium, Potassium and Calcium (Total)

Time frame:Week 0, week 52

change from baseline, descriptive

Secondary/protocol endpoint

Change in Biochemistry: Calcitonin

Time frame:Week 0, week 52

Thyroid event

change from baseline, descriptive

Secondary/protocol endpoint

Change in Biochemistry: TSH

Time frame:Week 0, week 52

Thyroid event

change from baseline, descriptive

Secondary/protocol endpoint

Change in Mental Health Assessed by C-SSRS

Time frame:Week 0 and Week 4-59

descriptive, event

Secondary/protocol endpoint

Anti-semaglutide Antibodies During and After Treatment

Time frame:Week 0-52

Immunogenicity (ADA)

descriptive

Other clinical outcomes

4 endpoints

Secondary/registry result

Participants With Change in Concomitant Medications (Antihypertensive and Lipid-lowering Medications)

Time frame:Week 0, Week 52

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 0.05 mgWeek 0: Antihypertensive medication (Yes)	37	—
Week 0: Antihypertensive medication (No)	66	—
Week 52: Antihypertensive medication (Decreased)	3	—
Week 52: Antihypertensive medication (No change)	68	—
Week 52: Antihypertensive medication (Increased)	4	—
Week 52: Antihypertensive medication (Missing)	2	—
Week 0: Lipid-lowering medication (Yes)	20	—
Week 0: Lipid-lowering medication (No)	83	—
Week 52: Lipid-lowering medication (Decreased)	0	—
Week 52: Lipid-lowering medication (No change)	73	—
Week 52: Lipid-lowering medication (Increased)	2	—
Week 52: Lipid-lowering medication (Missing)	2	—
Semaglutide 0.1 mgWeek 0: Antihypertensive medication (Yes)	31	—
Week 0: Antihypertensive medication (No)	71	—
Week 52: Antihypertensive medication (Decreased)	3	—
Week 52: Antihypertensive medication (No change)	74	—
Week 52: Antihypertensive medication (Increased)	9	—
Week 52: Antihypertensive medication (Missing)	2	—
Week 0: Lipid-lowering medication (Yes)	17	—
Week 0: Lipid-lowering medication (No)	85	—
Week 52: Lipid-lowering medication (Decreased)	1	—
Week 52: Lipid-lowering medication (No change)	83	—
Week 52: Lipid-lowering medication (Increased)	2	—
Week 52: Lipid-lowering medication (Missing)	2	—
Semaglutide 0.2 mgWeek 0: Antihypertensive medication (Yes)	28	—
Week 0: Antihypertensive medication (No)	75	—
Week 52: Antihypertensive medication (Decreased)	8	—
Week 52: Antihypertensive medication (No change)	76	—
Week 52: Antihypertensive medication (Increased)	2	—
Week 52: Antihypertensive medication (Missing)	1	—
Week 0: Lipid-lowering medication (Yes)	13	—
Week 0: Lipid-lowering medication (No)	90	—
Week 52: Lipid-lowering medication (Decreased)	3	—
Week 52: Lipid-lowering medication (No change)	81	—
Week 52: Lipid-lowering medication (Increased)	2	—
Week 52: Lipid-lowering medication (Missing)	1	—
Semaglutide 0.3 mgWeek 0: Antihypertensive medication (Yes)	31	—
Week 0: Antihypertensive medication (No)	72	—
Week 52: Antihypertensive medication (Decreased)	6	—
Week 52: Antihypertensive medication (No change)	75	—
Week 52: Antihypertensive medication (Increased)	6	—
Week 52: Antihypertensive medication (Missing)	1	—
Week 0: Lipid-lowering medication (Yes)	15	—
Week 0: Lipid-lowering medication (No)	88	—
Week 52: Lipid-lowering medication (Decreased)	1	—
Week 52: Lipid-lowering medication (No change)	84	—
Week 52: Lipid-lowering medication (Increased)	2	—
Week 52: Lipid-lowering medication (Missing)	1	—
Semaglutide 0.4 mgWeek 0: Antihypertensive medication (Yes)	36	—
Week 0: Antihypertensive medication (No)	66	—
Week 52: Antihypertensive medication (Decreased)	10	—
Week 52: Antihypertensive medication (No change)	70	—
Week 52: Antihypertensive medication (Increased)	2	—
Week 52: Antihypertensive medication (Missing)	0	—
Week 0: Lipid-lowering medication (Yes)	22	—
Week 0: Lipid-lowering medication (No)	80	—
Week 52: Lipid-lowering medication (Decreased)	1	—
Week 52: Lipid-lowering medication (No change)	79	—
Week 52: Lipid-lowering medication (Increased)	2	—
Week 52: Lipid-lowering medication (Missing)	0	—
Semaglutide 0.3 mg (Fast Escalation)Week 0: Antihypertensive medication (Yes)	32	—
Week 0: Antihypertensive medication (No)	70	—
Week 52: Antihypertensive medication (Decreased)	6	—
Week 52: Antihypertensive medication (No change)	64	—
Week 52: Antihypertensive medication (Increased)	5	—
Week 52: Antihypertensive medication (Missing)	0	—
Week 0: Lipid-lowering medication (Yes)	20	—
Week 0: Lipid-lowering medication (No)	82	—
Week 52: Lipid-lowering medication (Decreased)	3	—
Week 52: Lipid-lowering medication (No change)	71	—
Week 52: Lipid-lowering medication (Increased)	1	—
Week 52: Lipid-lowering medication (Missing)	0	—
Semaglutide 0.4 mg (Fast Escalation)Week 0: Antihypertensive medication (Yes)	29	—
Week 0: Antihypertensive medication (No)	74	—
Week 52: Antihypertensive medication (Decreased)	7	—
Week 52: Antihypertensive medication (No change)	80	—
Week 52: Antihypertensive medication (Increased)	4	—
Week 52: Antihypertensive medication (Missing)	0	—
Week 0: Lipid-lowering medication (Yes)	13	—
Week 0: Lipid-lowering medication (No)	90	—
Week 52: Lipid-lowering medication (Decreased)	3	—
Week 52: Lipid-lowering medication (No change)	87	—
Week 52: Lipid-lowering medication (Increased)	1	—
Week 52: Lipid-lowering medication (Missing)	0	—
Liraglutide 3.0 mgWeek 0: Antihypertensive medication (Yes)	36	—
Week 0: Antihypertensive medication (No)	67	—
Week 52: Antihypertensive medication (Decreased)	3	—
Week 52: Antihypertensive medication (No change)	74	—
Week 52: Antihypertensive medication (Increased)	8	—
Week 52: Antihypertensive medication (Missing)	1	—
Week 0: Lipid-lowering medication (Yes)	25	—
Week 0: Lipid-lowering medication (No)	78	—
Week 52: Lipid-lowering medication (Decreased)	1	—
Week 52: Lipid-lowering medication (No change)	83	—
Week 52: Lipid-lowering medication (Increased)	1	—
Week 52: Lipid-lowering medication (Missing)	1	—
Placebo PoolWeek 0: Antihypertensive medication (Yes)	50	—
Week 0: Antihypertensive medication (No)	86	—
Week 52: Antihypertensive medication (Decreased)	6	—
Week 52: Antihypertensive medication (No change)	89	—
Week 52: Antihypertensive medication (Increased)	6	—
Week 52: Antihypertensive medication (Missing)	2	—
Week 0: Lipid-lowering medication (Yes)	28	—
Week 0: Lipid-lowering medication (No)	108	—
Week 52: Lipid-lowering medication (Decreased)	2	—
Week 52: Lipid-lowering medication (No change)	94	—
Week 52: Lipid-lowering medication (Increased)	5	—
Week 52: Lipid-lowering medication (Missing)	2	—

Secondary/registry result

Compliance With Nutritional Counselling

Time frame:Week 4-52

descriptive

Posted result

Group	Value (mean), Score on a scale	95% CI
Semaglutide 0.05 mgWeek-4	6.85	—
Week-8	6.53	—
Week-12	6.70	—
Week-16	6.85	—
Week-20	6.92	—
Week-24	6.49	—
Week-28	6.94	—
Week-32	6.83	—
Week-36	6.87	—
Week-40	6.86	—
Week-44	6.83	—
Week-48	6.82	—
Week-52	7.23	—
Semaglutide 0.1 mgWeek-4	7.30	—
Week-8	7.24	—
Week-12	7.26	—
Week-16	7.22	—
Week-20	7.20	—
Week-24	7.14	—
Week-28	7.54	—
Week-32	6.97	—
Week-36	7.12	—
Week-40	6.88	—
Week-44	6.95	—
Week-48	7.05	—
Week-52	7.22	—
Semaglutide 0.2 mgWeek-4	7.17	—
Week-8	6.82	—
Week-12	7.22	—
Week-16	7.36	—
Week-20	6.87	—
Week-24	7.07	—
Week-28	7.10	—
Week-32	7.12	—
Week-36	7.03	—
Week-40	7.07	—
Week-44	6.96	—
Week-48	6.88	—
Week-52	7.05	—
Semaglutide 0.3 mgWeek-4	7.07	—
Week-8	7.13	—
Week-12	7.04	—
Week-16	7.04	—
Week-20	7.14	—
Week-24	7.17	—
Week-28	7.11	—
Week-32	7.07	—
Week-36	6.86	—
Week-40	7.03	—
Week-44	6.96	—
Week-48	6.92	—
Week-52	6.85	—
Semaglutide 0.4 mgWeek-4	7.20	—
Week-8	7.00	—
Week-12	7.11	—
Week-16	7.61	—
Week-20	7.64	—
Week-24	7.63	—
Week-28	7.46	—
Week-32	7.72	—
Week-36	7.20	—
Week-40	7.40	—
Week-44	7.30	—
Week-48	7.12	—
Week-52	7.36	—
Semaglutide 0.3 mg (Fast Escalation)Week-4	7.05	—
Week-8	7.25	—
Week-12	7.35	—
Week-16	7.27	—
Week-20	7.24	—
Week-24	7.05	—
Week-28	7.53	—
Week-32	7.13	—
Week-36	7.33	—
Week-40	7.01	—
Week-44	6.87	—
Week-48	7.01	—
Week-52	7.36	—
Semaglutide 0.4 mg (Fast Escalation)Week-4	7.30	—
Week-8	7.65	—
Week-12	7.64	—
Week-16	7.71	—
Week-20	7.74	—
Week-24	7.55	—
Week-28	7.47	—
Week-32	7.29	—
Week-36	7.34	—
Week-40	7.26	—
Week-44	7.30	—
Week-48	7.23	—
Week-52	7.31	—
Liraglutide 3.0 mgWeek-4	7.21	—
Week-8	6.92	—
Week-12	7.01	—
Week-16	6.98	—
Week-20	6.85	—
Week-24	6.69	—
Week-28	6.69	—
Week-32	6.94	—
Week-36	6.63	—
Week-40	6.52	—
Week-44	6.60	—
Week-48	6.01	—
Week-52	6.87	—
Placebo PoolWeek-4	6.08	—
Week-8	5.85	—
Week-12	6.14	—
Week-16	6.31	—
Week-20	6.24	—
Week-24	6.06	—
Week-28	6.34	—
Week-32	5.86	—
Week-36	6.10	—
Week-40	5.90	—
Week-44	5.99	—
Week-48	6.16	—
Week-52	6.09	—

Secondary/protocol endpoint

Participants With Change in Concomitant Medications (Antihypertensive and Lipid-lowering Medications)

Time frame:Week 0, Week 52

categorical status, descriptive

Secondary/protocol endpoint/low confidence

Compliance With Nutritional Counselling

Time frame:Week 4-52

descriptive, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change in Biochemistry: Albumin

Time frame:Week 0, week 52

change from baseline, descriptive

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

Validation of a new measure of quality of life in obesity trials: Impact of Weight on Quality of Life-Lite Clinical Trials Version.
Clinical obesity2019 Jun (month)PMID30993900doi:10.1111/cob.12310via CT.gov background + pubmed nct search
Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial.
Lancet (London, England)2018 Aug 25PMID30122305doi:10.1016/S0140-6736(18)31773-2via 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.