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STEP 5
CompletedPhase 3Results postedTwo-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
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
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 endpointsPercentage 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
| Group | Value (mean), percentage change | 95% 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 policy estimand
Hypothetical estimand
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
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide 2.4 mgIn-trial observation period | 111 | — |
| In-trial observation period | 33 | — |
| On-treatment observation period | 110 | — |
| On-treatment observation period | 22 | — |
| PlaceboIn-trial observation period | 44 | — |
| In-trial observation period | 84 | — |
| On-treatment observation period | 38 | — |
| On-treatment observation period | 71 | — |
Treatment policy estimand
Hypothetical estimand
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
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
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
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 89 | — |
| 55 | — | |
| Placebo | 17 | — |
| 111 | — |
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
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 75 | — |
| 69 | — | |
| Placebo | 9 | — |
| 119 | — |
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
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 52 | — |
| 92 | — | |
| Placebo | 3 | — |
| 125 | — |
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
| Group | Value (mean), centimeter (cm) | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | -15.2 | — |
| Placebo | -4.3 | — |
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
| Group | Value (mean), kilogram | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | -16.9 | — |
| Placebo | -2.1 | — |
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
| Group | Value (mean), kilogram per square meter (kg/m^2) | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | -6.2 | — |
| Placebo | -0.7 | — |
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
| Group | Value (mean), percentage change | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | -15.8 | — |
| Placebo | -3.3 | — |
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
| Group | Value (mean), kilogram (kg) | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | -16.7 | — |
| Placebo | -3.5 | — |
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
| Group | Value (mean), kilogram per square meter (kg/m^2) | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | -6.1 | — |
| Placebo | -1.3 | — |
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
| Group | Value (mean), centimeter (cm) | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | -14.3 | — |
| Placebo | -4.5 | — |
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
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 132 | — |
| 17 | — | |
| Placebo | 38 | — |
| 91 | — |
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
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 102 | — |
| 47 | — | |
| Placebo | 17 | — |
| 112 | — |
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
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 78 | — |
| 71 | — | |
| Placebo | 7 | — |
| 122 | — |
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
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 52 | — |
| 97 | — | |
| Placebo | 3 | — |
| 126 | — |
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
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
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
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
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
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
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
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
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
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
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
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
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
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 endpointsChange 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
| Group | Value (mean), Percent of glycated haemoglobin | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | -0.5 | — |
| Placebo | -0.1 | — |
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
| Group | Value (mean), mmol/mol | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | -5.1 | — |
| Placebo | -1.0 | — |
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
| Group | Value (mean), mmol/L | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | -0.5 | — |
| Placebo | 0.1 | — |
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
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | -8.3 | — |
| Placebo | 1.8 | — |
Change in Fasting Serum Insulin-ratio to Baseline (Pmol/L)
Time frame:From Baseline (Week 0) to Week 104
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of fasting serum insulin | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 0.68 | — |
| Placebo | 0.96 | — |
Change in Fasting Serum Insulin-ratio to Baseline (mIU/mL)
Time frame:From Baseline (Week 0) to Week 104
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of fasting serum insulin | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 0.68 | — |
| Placebo | 0.96 | — |
Change in Glycated Haemoglobin (HbA1c) (Percent [%])
Time frame:From Baseline (Week 0) to Week 104
HbA1c, change
change from baseline, improvement
LOINC 4548-4
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
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
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
Change in Fasting Serum Insulin-ratio to Baseline (Pmol/L)
Time frame:From Baseline (Week 0) to Week 104
ratio, improvement
Change in Fasting Serum Insulin-ratio to Baseline (mIU/mL)
Time frame:From Baseline (Week 0) to Week 104
ratio, improvement
Cardiometabolic biomarkers
20 endpointsChange 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
| Group | Value (mean), millimeter of mercury (mmHg) | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | -6 | — |
| Placebo | -1 | — |
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
| Group | Value (mean), mmHg | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | -4 | — |
| Placebo | -1 | — |
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
| Group | Value (geometric_mean), Ratio of total cholesterol | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 0.96 | — |
| Placebo | 1.02 | — |
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
| Group | Value (geometric_mean), Ratio of HDL cholesterol | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 1.09 | — |
| Placebo | 1.08 | — |
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
| Group | Value (geometric_mean), Ratio of LDL cholesterol | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 0.93 | — |
| Placebo | 0.99 | — |
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
| Group | Value (geometric_mean), Ratio of VLDL cholesterol | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 0.79 | — |
| Placebo | 1.03 | — |
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
| Group | Value (geometric_mean), Ratio of free fatty acids | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 0.99 | — |
| Placebo | 1.07 | — |
Change in Triglycerides-ratio to Baseline
Time frame:From Baseline (Week 0) to Week 104
Triglycerides, change
ratio, improvement
LOINC 2571-8
Posted result
| Group | Value (geometric_mean), Ratio of triglycerides | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 0.79 | — |
| Placebo | 1.03 | — |
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
| Group | Value (geometric_mean), Ratio of hsCRP | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 0.41 | — |
| Placebo | 0.99 | — |
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
| Group | Value (mean), beats per minute (beats/min) | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 3 | — |
| Placebo | -1 | — |
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
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
Change in Total Cholesterol-ratio to Baseline
Time frame:From Baseline (Week 0) to Week 104
Total cholesterol, change
ratio, improvement
LOINC 2093-3
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
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
Change in Very Low Density Lipoprotein (VLDL) Cholesterol-ratio to Baseline
Time frame:From Baseline (Week 0) to Week 104
VLDL, change
ratio, improvement
Change in Free Fatty Acids-ratio to Baseline
Time frame:From Baseline (Week 0) to Week 104
Free fatty acids, change
ratio, improvement
Change in Triglycerides-ratio to Baseline
Time frame:From Baseline (Week 0) to Week 104
Triglycerides, change
ratio, improvement
LOINC 2571-8
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
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 endpointsNumber of Treatment-emergent Adverse Events (TEAEs)
Time frame:From Baseline (Week 0) to Week 111
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (number), events | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 1645 | — |
| Placebo | 1059 | — |
Number of Serious Adverse Events (SAEs)
Time frame:From Baseline (Week 0) to Week 111
Serious AEs (any)
event count, event
Posted result
| Group | Value (number), events | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 18 | — |
| Placebo | 20 | — |
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
| Group | Value (geometric_mean), Units/liter (U/L) | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 1.13 | — |
| Placebo | 1.02 | — |
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
| Group | Value (geometric_mean), U/L | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 1.47 | — |
| Placebo | 1.00 | — |
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
| Group | Value (geometric_mean), nanogram per liter (ng/L) | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 0.99 | — |
| Placebo | 0.97 | — |
Number of Treatment-emergent Adverse Events (TEAEs)
Time frame:From Baseline (Week 0) to Week 111
Treatment-emergent AEs (any)
event count, event
Number of Serious Adverse Events (SAEs)
Time frame:From Baseline (Week 0) to Week 111
Serious AEs (any)
event count, event
Change From Baseline (Week 0) to Week 104 in Amylase
Time frame:From Baseline (Week 0) to Week 104
change from baseline, descriptive
Change From Baseline (Week 0) to Week 104 in Lipase
Time frame:From Baseline (Week 0) to Week 104
change from baseline, descriptive
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
- JAMA internal medicine2024 Nov 1PMID39226070doi:10.1001/jamainternmed.2024.4346via clinicaltrials gov reference derived + pubmed nct search
- Obesity (Silver Spring, Md.)2023 Sep (month)PMID37605636doi:10.1002/oby.23842via clinicaltrials gov reference derived + pubmed nct search
- Nature medicine2022 Oct (month)PMID36216945doi:10.1038/s41591-022-02026-4via clinicaltrials gov reference derived + pubmed nct search
- Obesity (Silver Spring, Md.)2020 Jun (month)PMID32441473doi:10.1002/oby.22794via CT.gov background + pubmed nct search
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.