STEP 8

CompletedPhase 3Results posted

Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity

Effect and Safety of Subcutaneous Semaglutide 2.4 mg Once Weekly Compared to Liraglutide 3.0 mg Once Daily on Weight Management in Subjects With Overweight or Obesity

Lead sponsor

Novo Nordisk A/S

Assets

Liraglutide / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

338

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 IDNCT04074161

Org study IDNN9536-4576

Secondary IDU1111-1233-0977World Health Organization (WHO)

Timeline

Milestones

Study first posted2019-08-29actual

Study start2019-09-11actual

Primary completion2021-03-27actual

Study completion2021-05-11actual

Results first posted2022-04-27actual

Last update posted2023-05-19actual

Assets

Investigational agents

Liraglutide Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female, age 18 years or older at the time of signing informed consent

•Body mass index (BMI) equal to or above 30.0 kg/m^2 or equal to or above 27.0 kg/m^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease

•History of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion criteria

•HbA1c equal to or above 48 mmol/mol (6.5%) as measured by the central laboratory at screening

•History of type 1 or type 2 diabetes mellitus

•A self-reported change in body weight of more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records

Endpoints (64)

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

Cardiometabolic biomarkers

Weight & body composition

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

14 endpoints

Primary/registry result

Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Liraglutide 3.0 mg)

Time frame:Baseline (week 0), week 68

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage of body weight	95% CI
Semaglutide 2.4 mg	-16.4	—
Liraglutide 3.0 mg	-6.4	—

Treatment difference-9.3895% CI-11.97 – -6.80p<0.0001ANCOVA

Primary/protocol endpoint

Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Liraglutide 3.0 mg)

Time frame:Baseline (week 0), week 68

Body weight, % change

percent change from baseline, improvement

Secondary/registry result

Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no)

Time frame:From baseline (week 0) to week 68

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mgYes	83	—
No	34	—
Liraglutide 3.0 mgYes	30	—
No	87	—
Pooled PlaceboYes	12	—
No	66	—

Secondary/registry result

Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=15% (Yes/no)

Time frame:From baseline (week 0) to week 68

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mgYes	65	—
No	52	—
Liraglutide 3.0 mgYes	14	—
No	103	—
Pooled PlaceboYes	5	—
No	73	—

Secondary/registry result

Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=20% (Yes/no)

Time frame:From baseline (week 0) to week 68

≥20% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mgYes	45	—
No	72	—
Liraglutide 3.0 mgYes	7	—
No	110	—
Pooled PlaceboYes	2	—
No	76	—

Secondary/registry result

Change From Baseline (Week 0) to Week 68 in Waist Circumference

Time frame:Baseline (week 0), week 68

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), centimeters (cm)	95% CI
Semaglutide 2.4 mg	-13.6	—
Liraglutide 3.0 mg	-6.8	—
Pooled Placebo	-2.0	—

Secondary/registry result

Change From Baseline (Week 0) to Week 68 in Body Weight (Kilograms (kg))

Time frame:Baseline (week 0), week 68

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kilograms	95% CI
Semaglutide 2.4 mg	-15.8	—
Liraglutide 3.0 mg	-6.8	—
Pooled Placebo	-1.4	—

Secondary/registry result

Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Pooled Placebo and Liraglutide 3.0 mg Versus Pooled Placebo)

Time frame:Baseline (week 0), week 68

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage of body weight	95% CI
Semaglutide 2.4 mg	-16.4	—
Liraglutide 3.0 mg	-6.4	—
Pooled Placebo	-1.6	—

Secondary/protocol endpoint

Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no)

Time frame:From baseline (week 0) to week 68

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=15% (Yes/no)

Time frame:From baseline (week 0) to week 68

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=20% (Yes/no)

Time frame:From baseline (week 0) to week 68

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 68 in Waist Circumference

Time frame:Baseline (week 0), week 68

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 68 in Body Weight (Kilograms (kg))

Time frame:Baseline (week 0), week 68

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Pooled Placebo and Liraglutide 3.0 mg Versus Pooled Placebo)

Time frame:Baseline (week 0), week 68

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

14 endpoints

Secondary/registry result

Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (%)

Time frame:Baseline (week 0), week 68

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percenatge of HbA1c	95% CI
Semaglutide 2.4 mg	-0.3	—
Liraglutide 3.0 mg	-0.1	—
Pooled Placebo	0.1	—

Secondary/registry result

Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (Millimoles Per Mole (mmol/Mol))

Time frame:Baseline (week 0), week 68

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), mmol/mol	95% CI
Semaglutide 2.4 mg	-2.8	—
Liraglutide 3.0 mg	-1.0	—
Pooled Placebo	1.2	—

Secondary/registry result

Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mg/dL)

Time frame:Baseline (week 0), week 68

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mg/dL	95% CI
Semaglutide 2.4 mg	-9.0	—
Liraglutide 3.0 mg	-4.9	—
Pooled Placebo	2.4	—

Secondary/registry result

Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mmol/L)

Time frame:Baseline (week 0), week 68

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
Semaglutide 2.4 mg	-0.5	—
Liraglutide 3.0 mg	-0.3	—
Pooled Placebo	0.1	—

Secondary/registry result

Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Milli-international Units Per Liter (mIU/L)): Ratio to Baseline

Time frame:Baseline (week 0), week 68

ratio, improvement

LOINC 20448-7

Posted result

Group	Value (geometric_mean), Ratio of fasting serum insulin	95% CI
Semaglutide 2.4 mg	0.73	—
Liraglutide 3.0 mg	0.85	—
Pooled Placebo	0.98	—

Secondary/registry result

Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Picomoles Per Liter (Pmol/L)): Ratio to Baseline

Time frame:Baseline (week 0), week 68

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of fasting serum insulin	95% CI
Semaglutide 2.4 mg	0.73	—
Liraglutide 3.0 mg	0.85	—
Pooled Placebo	0.98	—

Secondary/registry result

Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D))

Time frame:Baseline (week 0), week 68

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mgBaseline (week 0): normo-glycaemia	72	—
Baseline (week 0): pre-diabetes	38	—
Baseline (week 0): type 2 diabetes	0	—
Week 68: normo-glycaemia	104	—
Week 68: pre-diabetes	5	—
Week 68: type 2 diabetes	1	—
Liraglutide 3.0 mgBaseline (week 0): normo-glycaemia	74	—
Baseline (week 0): pre-diabetes	37	—
Baseline (week 0): type 2 diabetes	0	—
Week 68: normo-glycaemia	89	—
Week 68: pre-diabetes	21	—
Week 68: type 2 diabetes	1	—
Pooled PlaceboBaseline (week 0): normo-glycaemia	47	—
Baseline (week 0): pre-diabetes	30	—
Baseline (week 0): type 2 diabetes	0	—
Week 68: normo-glycaemia	38	—
Week 68: pre-diabetes	36	—
Week 68: type 2 diabetes	3	—

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (%)

Time frame:Baseline (week 0), week 68

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (Millimoles Per Mole (mmol/Mol))

Time frame:Baseline (week 0), week 68

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mg/dL)

Time frame:Baseline (week 0), week 68

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mmol/L)

Time frame:Baseline (week 0), week 68

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Milli-international Units Per Liter (mIU/L)): Ratio to Baseline

Time frame:Baseline (week 0), week 68

ratio, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Picomoles Per Liter (Pmol/L)): Ratio to Baseline

Time frame:Baseline (week 0), week 68

ratio, improvement

Secondary/protocol endpoint

Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D))

Time frame:Baseline (week 0), week 68

categorical status, improvement

Cardiometabolic biomarkers

30 endpoints

Secondary/registry result

Change From Baseline (Week 0) to Week 68 in Systolic Blood Pressure

Time frame:Baseline (week 0), week 68

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), millimeters of mercury (mmHg)	95% CI
Semaglutide 2.4 mg	-7	—
Liraglutide 3.0 mg	-4	—
Pooled Placebo	5	—

Secondary/registry result

Change From Baseline (Week 0) to Week 68 in Diastolic Blood Pressure

Time frame:Baseline (week 0), week 68

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (mean), mmHg	95% CI
Semaglutide 2.4 mg	-5	—
Liraglutide 3.0 mg	-1	—
Pooled Placebo	1	—

Secondary/registry result

Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Milligram Per Deciliter (mg/dL)) (Ratio to Baseline)

Time frame:Baseline (week 0), week 68

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

Group	Value (geometric_mean), Ratio of total cholesterol	95% CI
Semaglutide 2.4 mg	0.92	—
Liraglutide 3.0 mg	1.00	—
Pooled Placebo	0.99	—

Secondary/registry result

Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Millimoles Per Liter (mmol/L)) (Ratio to Baseline)

Time frame:Baseline (week 0), week 68

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

Group	Value (geometric_mean), Ratio of total cholesterol	95% CI
Semaglutide 2.4 mg	0.92	—
Liraglutide 3.0 mg	1.00	—
Pooled Placebo	0.99	—

Secondary/registry result

Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mg/dL) (Ratio to Baseline)

Time frame:Baseline (week 0), week 68

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (geometric_mean), Ratio of HDL cholesterol	95% CI
Semaglutide 2.4 mg	0.99	—
Liraglutide 3.0 mg	1.02	—
Pooled Placebo	0.99	—

Secondary/registry result

Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mmol/L) (Ratio to Baseline)

Time frame:Baseline (week 0), week 68

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (geometric_mean), Ratio of HDL cholesterol	95% CI
Semaglutide 2.4 mg	0.99	—
Liraglutide 3.0 mg	1.02	—
Pooled Placebo	0.99	—

Secondary/registry result

Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mg/dL) (Ratio to Baseline)

Time frame:Baseline (week 0), week 68

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (geometric_mean), Ratio of LDL cholesterol	95% CI
Semaglutide 2.4 mg	0.93	—
Liraglutide 3.0 mg	1.01	—
Pooled Placebo	0.99	—

Secondary/registry result

Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mmol/L) (Ratio to Baseline)

Time frame:Baseline (week 0), week 68

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (geometric_mean), Ratio of LDL cholesterol	95% CI
Semaglutide 2.4 mg	0.93	—
Liraglutide 3.0 mg	1.01	—
Pooled Placebo	0.99	—

Secondary/registry result

Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) (Ratio to Baseline)

Time frame:Baseline (week 0), week 68

VLDL, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of VLDL cholesterol	95% CI
Semaglutide 2.4 mg	0.79	—
Liraglutide 3.0 mg	0.89	—
Pooled Placebo	0.97	—

Secondary/registry result

Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) (Ratio to Baseline)

Time frame:Baseline (week 0), week 68

VLDL, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of VLDL cholesterol	95% CI
Semaglutide 2.4 mg	0.79	—
Liraglutide 3.0 mg	0.89	—
Pooled Placebo	0.97	—

Secondary/registry result

Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mg/dL) (Ratio to Baseline)

Time frame:Baseline (week 0), week 68

Free fatty acids, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of FFA	95% CI
Semaglutide 2.4 mg	0.90	—
Liraglutide 3.0 mg	0.87	—
Pooled Placebo	1.10	—

Secondary/registry result

Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mmol/L) (Ratio to Baseline)

Time frame:Baseline (week 0), week 68

Free fatty acids, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of FFA	95% CI
Semaglutide 2.4 mg	0.90	—
Liraglutide 3.0 mg	0.87	—
Pooled Placebo	1.10	—

Secondary/registry result

Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mg/dL) (Ratio to Baseline)

Time frame:Baseline (week 0), week 68

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (geometric_mean), Ratio of triglycerides	95% CI
Semaglutide 2.4 mg	0.80	—
Liraglutide 3.0 mg	0.89	—
Pooled Placebo	0.98	—

Secondary/registry result

Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mmol/L) (Ratio to Baseline)

Time frame:Baseline (week 0), week 68

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (geometric_mean), Ratio of triglycerides	95% CI
Semaglutide 2.4 mg	0.80	—
Liraglutide 3.0 mg	0.89	—
Pooled Placebo	0.98	—

Secondary/registry result

Change From Baseline (Week 0) to Week 68 in High-sensitivity C-reactive Protein (Hs-CRP): Ratio to Baseline

Time frame:Baseline (week 0), week 68

hs-CRP, change

ratio, improvement

LOINC 30522-7

Posted result

Group	Value (geometric_mean), Ratio of hs-CRP	95% CI
Semaglutide 2.4 mg	0.46	—
Liraglutide 3.0 mg	0.73	—
Pooled Placebo	0.78	—

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 68 in Systolic Blood Pressure

Time frame:Baseline (week 0), week 68

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 68 in Diastolic Blood Pressure

Time frame:Baseline (week 0), week 68

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Milligram Per Deciliter (mg/dL)) (Ratio to Baseline)

Time frame:Baseline (week 0), week 68

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Millimoles Per Liter (mmol/L)) (Ratio to Baseline)

Time frame:Baseline (week 0), week 68

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mg/dL) (Ratio to Baseline)

Time frame:Baseline (week 0), week 68

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mmol/L) (Ratio to Baseline)

Time frame:Baseline (week 0), week 68

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mg/dL) (Ratio to Baseline)

Time frame:Baseline (week 0), week 68

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mmol/L) (Ratio to Baseline)

Time frame:Baseline (week 0), week 68

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) (Ratio to Baseline)

Time frame:Baseline (week 0), week 68

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) (Ratio to Baseline)

Time frame:Baseline (week 0), week 68

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mg/dL) (Ratio to Baseline)

Time frame:Baseline (week 0), week 68

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mmol/L) (Ratio to Baseline)

Time frame:Baseline (week 0), week 68

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mg/dL) (Ratio to Baseline)

Time frame:Baseline (week 0), week 68

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mmol/L) (Ratio to Baseline)

Time frame:Baseline (week 0), week 68

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 68 in High-sensitivity C-reactive Protein (Hs-CRP): Ratio to Baseline

Time frame:Baseline (week 0), week 68

hs-CRP, change

ratio, improvement

LOINC 30522-7

Safety / tolerability / PK

6 endpoints

Secondary/registry result

Number of Participants Who From Baseline (Week 0) to Week 68 Permanently Discontinued Randomized Trial Product

Time frame:From baseline (week 0) to week 68

Discontinuation due to AE

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mg	17	—
Liraglutide 3.0 mg	35	—
Pooled Placebo	15	—

Secondary/registry result

Number of Treatment Emergent Adverse Events (TEAEs) From Baseline (Week 0) to Week 75

Time frame:From baseline (week 0) to week 75

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Semaglutide 2.4 mg	904	—
Liraglutide 3.0 mg	823	—
Pooled Placebo	522	—

Secondary/registry result

Number of Serious Adverse Events (SAEs) From Baseline (Week 0) to Week 75

Time frame:From baseline (week 0) to week 75

Serious AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Semaglutide 2.4 mg	14	—
Liraglutide 3.0 mg	18	—
Pooled Placebo	9	—

Secondary/protocol endpoint

Number of Participants Who From Baseline (Week 0) to Week 68 Permanently Discontinued Randomized Trial Product

Time frame:From baseline (week 0) to week 68

Discontinuation due to AE

event count, event

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs) From Baseline (Week 0) to Week 75

Time frame:From baseline (week 0) to week 75

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Serious Adverse Events (SAEs) From Baseline (Week 0) to Week 75

Time frame:From baseline (week 0) to week 75

Serious AEs (any)

event count, event

Publications (3)

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

Ease-of-use and acceptability of the novel semaglutide 2.4 mg single-dose pen-injector in people with overweight or obesity in the STEP 8 phase III trial.
Diabetes, obesity & metabolism2022 Nov (month)PMID35791625doi:10.1111/dom.14809via clinicaltrials gov reference derived + pubmed nct search
Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight in Adults With Overweight or Obesity Without Diabetes: The STEP 8 Randomized Clinical Trial.
JAMA2022 Jan 11PMID35015037doi:10.1001/jama.2021.23619via CT.gov reference + pubmed nct search
Managing the gastrointestinal side effects of GLP-1 receptor agonists in obesity: recommendations for clinical practice.
Postgraduate medicine2022 Jan (month)PMID34775881doi:10.1080/00325481.2021.2002616via CT.gov reference

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.