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STEP 5

CompletedPhase 3Results posted

Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

Two-year Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

41

Recruiting sites

Enrollment

304

actual

Study population

Obesity / overweight

Key I/E criterion

Primary endpoints

Body weight, % change≥5% weight-loss responders

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 IDNCT03693430
Org study IDNN9536-4378
Secondary ID2017-003726-32European Medicines Agency (EudraCT)
Secondary IDU1111-1202-1740World Health Organization (WHO)

Timeline

Milestones

Study first posted2018-10-03actual
Study start2018-10-05actual
Primary completion2021-01-29actual
Study completion2021-03-23actual
Results first posted2022-03-23actual
Last update posted2023-07-06actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted

Inclusion criteria

Male or female, age more than or equal to 18 years at the time of signing informed consent
Body mass index (BMI) more than or equal to 30 kg/m^2 or more than or equal to 27 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 more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records

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

Weight & body composition
32
Cardiometabolic biomarkers
20
Glycemic / diabetes
12
Safety / tolerability / PK
10

Weight & body composition

32 endpoints
Primary/registry result

Percentage Change From Baseline (Week 0) to Week 104 in Body Weight

Time frame:From Baseline (Week 0) to Week 104

Body weight, % change

percent change from baseline, improvement

Posted result

GroupValue (mean), percentage change95% CI
Semaglutide 2.4 mgIn-trial observation period-15.9
On-treatment observation period-17.3
PlaceboIn-trial observation period-1.9
On-treatment observation period-2.0
Treatment difference-12.5595% CI-15.33-9.77p<.0001ANCOVA

Treatment policy estimand

Treatment difference-16.0595% CI-18.64-13.45p<0.0001MMRM (Mixed model repeated measurement)

Hypothetical estimand

Primary/registry result

Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5%

Time frame:At Week 104

≥5% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (count_of_participants), Participants95% CI
Semaglutide 2.4 mgIn-trial observation period111
In-trial observation period33
On-treatment observation period110
On-treatment observation period22
PlaceboIn-trial observation period44
In-trial observation period84
On-treatment observation period38
On-treatment observation period71
Odds Ratio (OR)4.9995% CI2.958.42p<0.0001Regression, Logistic

Treatment policy estimand

Odds Ratio (OR)18.0695% CI10.0432.49p<0.0001MMRM

Hypothetical estimand

Primary/protocol endpoint

Percentage Change From Baseline (Week 0) to Week 104 in Body Weight

Time frame:From Baseline (Week 0) to Week 104

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5%

Time frame:At Week 104

≥5% weight-loss responders

threshold achievement, improvement

Secondary/registry result

Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10%

Time frame:At Week 104

≥10% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (count_of_participants), Participants95% CI
Semaglutide 2.4 mg89
55
Placebo17
111
Secondary/registry result

Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15%

Time frame:At Week 104

≥15% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (count_of_participants), Participants95% CI
Semaglutide 2.4 mg75
69
Placebo9
119
Secondary/registry result

Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20%

Time frame:At Week 104

≥20% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (count_of_participants), Participants95% CI
Semaglutide 2.4 mg52
92
Placebo3
125
Secondary/registry result

Change From Baseline (Week 0) to Week 104 in Waist Circumference

Time frame:From Baseline (Week 0) to Week 104

Waist circumference, change

change from baseline, improvement

Posted result

GroupValue (mean), centimeter (cm)95% CI
Semaglutide 2.4 mg-15.2
Placebo-4.3
Secondary/registry result

Change From Baseline (Week 0) to Week 104 in Body Weight (kg)

Time frame:From Baseline (Week 0) to Week 104

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), kilogram95% CI
Semaglutide 2.4 mg-16.9
Placebo-2.1
Secondary/registry result

Change From Baseline (Week 0) to Week 104 in Body Mass Index (BMI)

Time frame:From Baseline (Week 0) to Week 104

BMI, change

change from baseline, improvement

Posted result

GroupValue (mean), kilogram per square meter (kg/m^2)95% CI
Semaglutide 2.4 mg-6.2
Placebo-0.7
Secondary/registry result

Percentage Change From Baseline (Week 0) to Week 52 in Body Weight

Time frame:From Baseline (Week 0) to Week 52

Body weight, % change

percent change from baseline, improvement

Posted result

GroupValue (mean), percentage change95% CI
Semaglutide 2.4 mg-15.8
Placebo-3.3
Secondary/registry result

Change From Baseline (Week 0) to Week 52 in Body Weight (kg)

Time frame:From Baseline (Week 0) to Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), kilogram (kg)95% CI
Semaglutide 2.4 mg-16.7
Placebo-3.5
Secondary/registry result

Change From Baseline (Week 0) to Week 52 in Body Mass Index (BMI)

Time frame:From Baseline (Week 0) to Week 52

BMI, change

change from baseline, improvement

Posted result

GroupValue (mean), kilogram per square meter (kg/m^2)95% CI
Semaglutide 2.4 mg-6.1
Placebo-1.3
Secondary/registry result

Change From Baseline (Week 0) to Week 52 in Waist Circumference

Time frame:From Baseline (Week 0) to Week 52

Waist circumference, change

change from baseline, improvement

Posted result

GroupValue (mean), centimeter (cm)95% CI
Semaglutide 2.4 mg-14.3
Placebo-4.5
Secondary/registry result

Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5%

Time frame:At Week 52

≥5% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (count_of_participants), Participants95% CI
Semaglutide 2.4 mg132
17
Placebo38
91
Secondary/registry result

Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10%

Time frame:At Week 52

≥10% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (count_of_participants), Participants95% CI
Semaglutide 2.4 mg102
47
Placebo17
112
Secondary/registry result

Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15%

Time frame:At Week 52

≥15% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (count_of_participants), Participants95% CI
Semaglutide 2.4 mg78
71
Placebo7
122
Secondary/registry result

Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20%

Time frame:At Week 52

≥20% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (count_of_participants), Participants95% CI
Semaglutide 2.4 mg52
97
Placebo3
126
Secondary/protocol endpoint

Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10%

Time frame:At Week 104

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15%

Time frame:At Week 104

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20%

Time frame:At Week 104

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 104 in Waist Circumference

Time frame:From Baseline (Week 0) to Week 104

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 104 in Body Weight (kg)

Time frame:From Baseline (Week 0) to Week 104

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 104 in Body Mass Index (BMI)

Time frame:From Baseline (Week 0) to Week 104

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Percentage Change From Baseline (Week 0) to Week 52 in Body Weight

Time frame:From Baseline (Week 0) to Week 52

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 52 in Body Weight (kg)

Time frame:From Baseline (Week 0) to Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 52 in Body Mass Index (BMI)

Time frame:From Baseline (Week 0) to Week 52

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 52 in Waist Circumference

Time frame:From Baseline (Week 0) to Week 52

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5%

Time frame:At Week 52

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10%

Time frame:At Week 52

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15%

Time frame:At Week 52

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20%

Time frame:At Week 52

≥20% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

12 endpoints
Secondary/registry result

Change in Glycated Haemoglobin (HbA1c) (Percent [%])

Time frame:From Baseline (Week 0) to Week 104

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), Percent of glycated haemoglobin95% CI
Semaglutide 2.4 mg-0.5
Placebo-0.1
Secondary/registry result

Change From Baseline (Week 0) to Week 104 in HbA1c (mmol/Mol)

Time frame:From Baseline (Week 0) to Week 104

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), mmol/mol95% CI
Semaglutide 2.4 mg-5.1
Placebo-1.0
Secondary/registry result

Change From Baseline (Week 0) to Week 104 in Fasting Plasma Glucose (FPG) (mmol/L)

Time frame:From Baseline (Week 0) to Week 104

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (mean), mmol/L95% CI
Semaglutide 2.4 mg-0.5
Placebo0.1
Secondary/registry result

Change From Baseline (Week 0) to Week 104 in FPG (mg/dL)

Time frame:From Baseline (Week 0) to Week 104

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (mean), mg/dL95% CI
Semaglutide 2.4 mg-8.3
Placebo1.8
Secondary/registry result

Change in Fasting Serum Insulin-ratio to Baseline (Pmol/L)

Time frame:From Baseline (Week 0) to Week 104

ratio, improvement

Posted result

GroupValue (geometric_mean), Ratio of fasting serum insulin95% CI
Semaglutide 2.4 mg0.68
Placebo0.96
Secondary/registry result

Change in Fasting Serum Insulin-ratio to Baseline (mIU/mL)

Time frame:From Baseline (Week 0) to Week 104

ratio, improvement

Posted result

GroupValue (geometric_mean), Ratio of fasting serum insulin95% CI
Semaglutide 2.4 mg0.68
Placebo0.96
Secondary/protocol endpoint

Change in Glycated Haemoglobin (HbA1c) (Percent [%])

Time frame:From Baseline (Week 0) to Week 104

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 104 in HbA1c (mmol/Mol)

Time frame:From Baseline (Week 0) to Week 104

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 104 in Fasting Plasma Glucose (FPG) (mmol/L)

Time frame:From Baseline (Week 0) to Week 104

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 104 in FPG (mg/dL)

Time frame:From Baseline (Week 0) to Week 104

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

Change in Fasting Serum Insulin-ratio to Baseline (Pmol/L)

Time frame:From Baseline (Week 0) to Week 104

ratio, improvement

Secondary/protocol endpoint

Change in Fasting Serum Insulin-ratio to Baseline (mIU/mL)

Time frame:From Baseline (Week 0) to Week 104

ratio, improvement

Cardiometabolic biomarkers

20 endpoints
Secondary/registry result

Change From Baseline (Week 0) to Week 104 in Systolic Blood Pressure

Time frame:From Baseline (Week 0) to Week 104

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

GroupValue (mean), millimeter of mercury (mmHg)95% CI
Semaglutide 2.4 mg-6
Placebo-1
Secondary/registry result

Change From Baseline (Week 0) to Week 104 in Diastolic Blood Pressure

Time frame:From Baseline (Week 0) to Week 104

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

GroupValue (mean), mmHg95% CI
Semaglutide 2.4 mg-4
Placebo-1
Secondary/registry result

Change in Total Cholesterol-ratio to Baseline

Time frame:From Baseline (Week 0) to Week 104

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

GroupValue (geometric_mean), Ratio of total cholesterol95% CI
Semaglutide 2.4 mg0.96
Placebo1.02
Secondary/registry result

Change in High Density Lipoprotein (HDL) Cholesterol-ratio to Baseline

Time frame:From Baseline (Week 0) to Week 104

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

GroupValue (geometric_mean), Ratio of HDL cholesterol95% CI
Semaglutide 2.4 mg1.09
Placebo1.08
Secondary/registry result

Change in Low Density Lipoprotein (LDL) Cholesterol-ratio to Baseline

Time frame:From Baseline (Week 0) to Week 104

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

GroupValue (geometric_mean), Ratio of LDL cholesterol95% CI
Semaglutide 2.4 mg0.93
Placebo0.99
Secondary/registry result

Change in Very Low Density Lipoprotein (VLDL) Cholesterol-ratio to Baseline

Time frame:From Baseline (Week 0) to Week 104

VLDL, change

ratio, improvement

Posted result

GroupValue (geometric_mean), Ratio of VLDL cholesterol95% CI
Semaglutide 2.4 mg0.79
Placebo1.03
Secondary/registry result

Change in Free Fatty Acids-ratio to Baseline

Time frame:From Baseline (Week 0) to Week 104

Free fatty acids, change

ratio, improvement

Posted result

GroupValue (geometric_mean), Ratio of free fatty acids95% CI
Semaglutide 2.4 mg0.99
Placebo1.07
Secondary/registry result

Change in Triglycerides-ratio to Baseline

Time frame:From Baseline (Week 0) to Week 104

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

GroupValue (geometric_mean), Ratio of triglycerides95% CI
Semaglutide 2.4 mg0.79
Placebo1.03
Secondary/registry result

Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline

Time frame:From Baseline (Week 0) to Week 104

hs-CRP, change

ratio, improvement

LOINC 30522-7

Posted result

GroupValue (geometric_mean), Ratio of hsCRP95% CI
Semaglutide 2.4 mg0.41
Placebo0.99
Secondary/registry result

Change From Baseline (Week 0) to Week 104 in Pulse

Time frame:From Baseline (Week 0) to Week 104

Heart rate, change

change from baseline, improvement

Posted result

GroupValue (mean), beats per minute (beats/min)95% CI
Semaglutide 2.4 mg3
Placebo-1
Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 104 in Systolic Blood Pressure

Time frame:From Baseline (Week 0) to Week 104

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 104 in Diastolic Blood Pressure

Time frame:From Baseline (Week 0) to Week 104

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change in Total Cholesterol-ratio to Baseline

Time frame:From Baseline (Week 0) to Week 104

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in High Density Lipoprotein (HDL) Cholesterol-ratio to Baseline

Time frame:From Baseline (Week 0) to Week 104

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Low Density Lipoprotein (LDL) Cholesterol-ratio to Baseline

Time frame:From Baseline (Week 0) to Week 104

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in Very Low Density Lipoprotein (VLDL) Cholesterol-ratio to Baseline

Time frame:From Baseline (Week 0) to Week 104

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change in Free Fatty Acids-ratio to Baseline

Time frame:From Baseline (Week 0) to Week 104

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Change in Triglycerides-ratio to Baseline

Time frame:From Baseline (Week 0) to Week 104

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline

Time frame:From Baseline (Week 0) to Week 104

hs-CRP, change

ratio, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 104 in Pulse

Time frame:From Baseline (Week 0) to Week 104

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

10 endpoints
Secondary/registry result

Number of Treatment-emergent Adverse Events (TEAEs)

Time frame:From Baseline (Week 0) to Week 111

Treatment-emergent AEs (any)

event count, event

Posted result

GroupValue (number), events95% CI
Semaglutide 2.4 mg1645
Placebo1059
Secondary/registry result

Number of Serious Adverse Events (SAEs)

Time frame:From Baseline (Week 0) to Week 111

Serious AEs (any)

event count, event

Posted result

GroupValue (number), events95% CI
Semaglutide 2.4 mg18
Placebo20
Secondary/registry result

Change From Baseline (Week 0) to Week 104 in Amylase

Time frame:From Baseline (Week 0) to Week 104

change from baseline, descriptive

Posted result

GroupValue (geometric_mean), Units/liter (U/L)95% CI
Semaglutide 2.4 mg1.13
Placebo1.02
Secondary/registry result

Change From Baseline (Week 0) to Week 104 in Lipase

Time frame:From Baseline (Week 0) to Week 104

change from baseline, descriptive

Posted result

GroupValue (geometric_mean), U/L95% CI
Semaglutide 2.4 mg1.47
Placebo1.00
Secondary/registry result

Change From Baseline (Week 0) to Week 104 in Calcitonin

Time frame:From Baseline (Week 0) to Week 104

Thyroid event

change from baseline, descriptive

Posted result

GroupValue (geometric_mean), nanogram per liter (ng/L)95% CI
Semaglutide 2.4 mg0.99
Placebo0.97
Secondary/protocol endpoint

Number of Treatment-emergent Adverse Events (TEAEs)

Time frame:From Baseline (Week 0) to Week 111

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Serious Adverse Events (SAEs)

Time frame:From Baseline (Week 0) to Week 111

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 104 in Amylase

Time frame:From Baseline (Week 0) to Week 104

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 104 in Lipase

Time frame:From Baseline (Week 0) to Week 104

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline (Week 0) to Week 104 in Calcitonin

Time frame:From Baseline (Week 0) to Week 104

Thyroid event

change from baseline, descriptive

Publications (5)

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

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.