← Trials/Trial dossier/NCT05649137
A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight
Effect and Safety of Semaglutide 7.2 mg Once-weekly in Participants With Obesity and Type 2 Diabetes
Lead sponsor
Asset
Semaglutide
Subcutaneous · GLP-1 agonist
Listed sites
76
Recruiting sites
—
Enrollment
512
actual
Study population
Obesity / overweight, Type 2 diabetes
Key I/E criteria
•BMI ≥30•HbA1c 7-10%
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 (72)
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
16 endpointsRelative Change in Body Weight
Time frame:Baseline (week 0), End of treatment (week 72)
Body weight, % change
percent change from baseline, improvement
Posted result
| Group | Value (mean), Percentage (%) change in body weight | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | -13.5 | — |
| Semaglutide 2.4 mg | -10.7 | — |
| Placebo | -4.0 | — |
Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no)
Time frame:At week 72
≥5% weight-loss responders
threshold achievement, improvement
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 251 | — |
| 40 | — | |
| Semaglutide 2.4 mg | 73 | — |
| 24 | — | |
| Placebo | 33 | — |
| 62 | — |
Relative Change in Body Weight
Time frame:Baseline (week 0), End of treatment (week 72)
Body weight, % change
percent change from baseline, improvement
Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no)
Time frame:At week 72
≥5% weight-loss responders
threshold achievement, improvement
Number of Participants Who Achieve Body Weight Reduction >= 10% (Yes/no)
Time frame:At week 72
≥10% weight-loss responders
threshold achievement, improvement
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 183 | — |
| 108 | — | |
| Semaglutide 2.4 mg | 50 | — |
| 47 | — | |
| Placebo | 11 | — |
| 84 | — |
Number of Participants Who Achieve Body Weight Reduction >= 15% (Yes/no)
Time frame:At week 72
≥15% weight-loss responders
threshold achievement, improvement
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 120 | — |
| 171 | — | |
| Semaglutide 2.4 mg | 28 | — |
| 69 | — | |
| Placebo | 7 | — |
| 88 | — |
Number of Participants Who Achieve Body Weight Reduction >= 20% (Yes/no)
Time frame:At week 72
≥20% weight-loss responders
threshold achievement, improvement
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 62 | — |
| 229 | — | |
| Semaglutide 2.4 mg | 14 | — |
| 83 | — | |
| Placebo | 2 | — |
| 93 | — |
Change in Waist Circumference
Time frame:Baseline (week 0), End of treatment (week 72)
Waist circumference, change
change from baseline, improvement
Posted result
| Group | Value (mean), Centimeters (cm) | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | -12.6 | — |
| Semaglutide 2.4 mg | -10.6 | — |
| Placebo | -6.5 | — |
Change in Body Weight
Time frame:Baseline (week 0), End of treatment (week 72)
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), Kilograms (kg) | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | -14.9 | — |
| Semaglutide 2.4 mg | -11.4 | — |
| Placebo | -4.6 | — |
Change in Body Mass Index (BMI)
Time frame:Baseline (week 0), End of treatment (week 72)
BMI, change
change from baseline, improvement
Posted result
| Group | Value (mean), kilograms per meter square (kg/m^2) | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | -5.3 | — |
| Semaglutide 2.4 mg | -4.1 | — |
| Placebo | -1.6 | — |
Number of Participants Who Achieve Body Weight Reduction >= 10% (Yes/no)
Time frame:At week 72
≥10% weight-loss responders
threshold achievement, improvement
Number of Participants Who Achieve Body Weight Reduction >= 15% (Yes/no)
Time frame:At week 72
≥15% weight-loss responders
threshold achievement, improvement
Number of Participants Who Achieve Body Weight Reduction >= 20% (Yes/no)
Time frame:At week 72
≥20% weight-loss responders
threshold achievement, improvement
Change in Waist Circumference
Time frame:Baseline (week 0), End of treatment (week 72)
Waist circumference, change
change from baseline, improvement
Change in Body Weight
Time frame:Baseline (week 0), End of treatment (week 72)
Body weight, absolute change (kg)
change from baseline, improvement
Change in Body Mass Index (BMI)
Time frame:Baseline (week 0), End of treatment (week 72)
BMI, change
change from baseline, improvement
Glycemic / diabetes
12 endpointsChange in Glycated Haemoglobin (HbA1c)
Time frame:Baseline (week 0), End of treatment (week 72)
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), Percentage of HbA1c | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | -1.8 | — |
| Semaglutide 2.4 mg | -1.7 | — |
| Placebo | -0.3 | — |
Change in Fasting Plasma Glucose
Time frame:Baseline (week 0), End of treatment (week 72)
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | -59.6 | — |
| Semaglutide 2.4 mg | -58.4 | — |
| Placebo | -20.2 | — |
Change in Fasting Serum Insulin (Picomoles Per Liter [Pmol/L]) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of fasting serum insulin | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 0.77 | — |
| Semaglutide 2.4 mg | 0.90 | — |
| Placebo | 0.87 | — |
Change in Fasting Serum Insulin (Milliinternational Units Per Milliliter [mIU/mL]) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of fasting serum insulin | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 0.77 | — |
| Semaglutide 2.4 mg | 0.90 | — |
| Placebo | 0.87 | — |
Number of Participants With HbA1c Less Than 7.0 % (53 Millimoles Per Mole [mmol/Mol])
Time frame:At week 72
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 235 | — |
| Semaglutide 2.4 mg | 75 | — |
| Placebo | 27 | — |
Number of Participants With HbA1c Less Than or Equal to 6.5% (48 mmol/Mol)
Time frame:At week 72
HbA1c <6.5% achievement
threshold achievement, improvement
LOINC 4548-4
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 209 | — |
| Semaglutide 2.4 mg | 64 | — |
| Placebo | 15 | — |
Change in Glycated Haemoglobin (HbA1c)
Time frame:Baseline (week 0), End of treatment (week 72)
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in Fasting Plasma Glucose
Time frame:Baseline (week 0), End of treatment (week 72)
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change in Fasting Serum Insulin (Picomoles Per Liter [Pmol/L]) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
ratio, improvement
Change in Fasting Serum Insulin (Milliinternational Units Per Milliliter [mIU/mL]) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
ratio, improvement
Number of Participants With HbA1c Less Than 7.0 % (53 Millimoles Per Mole [mmol/Mol])
Time frame:At week 72
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Number of Participants With HbA1c Less Than or Equal to 6.5% (48 mmol/Mol)
Time frame:At week 72
HbA1c <6.5% achievement
threshold achievement, improvement
LOINC 4548-4
Cardiometabolic biomarkers
32 endpointsChange in Systolic Blood Pressure
Time frame:Baseline (week 0), End of treatment (week 72)
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Posted result
| Group | Value (mean), Millimeters of mercury (mmHg) | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | -8 | — |
| Semaglutide 2.4 mg | -7 | — |
| Placebo | -3 | — |
Change in Diastolic Blood Pressure
Time frame:Baseline (week 0), End of treatment (week 72)
Diastolic BP, change
change from baseline, improvement
LOINC 8462-4
Posted result
| Group | Value (mean), mmHg | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | -3 | — |
| Semaglutide 2.4 mg | -3 | — |
| Placebo | -3 | — |
Change in Total Cholesterol (Millimoles Per Liter [mmol/L]) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
Total cholesterol, change
ratio, improvement
LOINC 2093-3
Posted result
| Group | Value (geometric_mean), Ratio of total cholesterol | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 0.96 | — |
| Semaglutide 2.4 mg | 0.96 | — |
| Placebo | 0.97 | — |
Change in Total Cholesterol (Milligrams Per Deciliter [mg/dL]) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
Total cholesterol, change
ratio, improvement
LOINC 2093-3
Posted result
| Group | Value (geometric_mean), Ratio of total cholesterol | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 0.96 | — |
| Semaglutide 2.4 mg | 0.96 | — |
| Placebo | 0.97 | — |
Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
HDL-C, change
ratio, improvement
LOINC 2085-9
Posted result
| Group | Value (geometric_mean), Ratio of HDL cholesterol | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 1.10 | — |
| Semaglutide 2.4 mg | 1.06 | — |
| Placebo | 1.07 | — |
Change in HDL Cholesterol (mg/dL) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
HDL-C, change
ratio, improvement
LOINC 2085-9
Posted result
| Group | Value (geometric_mean), Ratio of HDL cholesterol | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 1.10 | — |
| Semaglutide 2.4 mg | 1.06 | — |
| Placebo | 1.07 | — |
Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
LDL-C, change
ratio, improvement
LOINC 13457-7
Posted result
| Group | Value (geometric_mean), Ratio of LDL cholesterol | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 0.99 | — |
| Semaglutide 2.4 mg | 0.95 | — |
| Placebo | 0.97 | — |
Change in LDL Cholesterol (mg/dL) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
LDL-C, change
ratio, improvement
LOINC 13457-7
Posted result
| Group | Value (geometric_mean), Ratio of LDL cholesterol | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 0.99 | — |
| Semaglutide 2.4 mg | 0.95 | — |
| Placebo | 0.97 | — |
Change in Very-low-density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
VLDL, change
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of VLDL cholesterol | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 0.72 | — |
| Semaglutide 2.4 mg | 0.81 | — |
| Placebo | 0.90 | — |
Change in VLDL Cholesterol (mg/dL) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
VLDL, change
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of VLDL cholesterol | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 0.72 | — |
| Semaglutide 2.4 mg | 0.81 | — |
| Placebo | 0.90 | — |
Change in Triglycerides (mmol/L) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
Triglycerides, change
ratio, improvement
LOINC 2571-8
Posted result
| Group | Value (geometric_mean), Ratio of triglycerides | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 0.71 | — |
| Semaglutide 2.4 mg | 0.80 | — |
| Placebo | 0.87 | — |
Change in Triglycerides (mg/dL) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
Triglycerides, change
ratio, improvement
LOINC 2571-8
Posted result
| Group | Value (geometric_mean), Ratio of triglycerides | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 0.71 | — |
| Semaglutide 2.4 mg | 0.80 | — |
| Placebo | 0.87 | — |
Change in Free Fatty Acids (mmol/L) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
Free fatty acids, change
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of free fatty acids | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 0.74 | — |
| Semaglutide 2.4 mg | 0.81 | — |
| Placebo | 0.98 | — |
Change in Free Fatty Acids (mg/dL) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
Free fatty acids, change
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of free fatty acids | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 0.74 | — |
| Semaglutide 2.4 mg | 0.81 | — |
| Placebo | 0.98 | — |
Change in High-sensitivity C-reactive Protein (hsCRP) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
hs-CRP, change
ratio, improvement
LOINC 30522-7
Posted result
| Group | Value (geometric_mean), Ratio of hsCRP | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 0.47 | — |
| Semaglutide 2.4 mg | 0.48 | — |
| Placebo | 0.82 | — |
Change in Pulse
Time frame:Baseline (week 0), End of treatment (week 72)
Heart rate, change
change from baseline, improvement
Posted result
| Group | Value (mean), Beats per minute (bpm) | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 1 | — |
| Semaglutide 2.4 mg | 2 | — |
| Placebo | -4 | — |
Change in Systolic Blood Pressure
Time frame:Baseline (week 0), End of treatment (week 72)
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Change in Diastolic Blood Pressure
Time frame:Baseline (week 0), End of treatment (week 72)
Diastolic BP, change
change from baseline, improvement
LOINC 8462-4
Change in Total Cholesterol (Millimoles Per Liter [mmol/L]) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
Total cholesterol, change
ratio, improvement
LOINC 2093-3
Change in Total Cholesterol (Milligrams Per Deciliter [mg/dL]) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
Total cholesterol, change
ratio, improvement
LOINC 2093-3
Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
HDL-C, change
ratio, improvement
LOINC 2085-9
Change in HDL Cholesterol (mg/dL) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
HDL-C, change
ratio, improvement
LOINC 2085-9
Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
LDL-C, change
ratio, improvement
LOINC 13457-7
Change in LDL Cholesterol (mg/dL) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
LDL-C, change
ratio, improvement
LOINC 13457-7
Change in Very-low-density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
VLDL, change
ratio, improvement
Change in VLDL Cholesterol (mg/dL) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
VLDL, change
ratio, improvement
Change in Triglycerides (mmol/L) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
Triglycerides, change
ratio, improvement
LOINC 2571-8
Change in Triglycerides (mg/dL) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
Triglycerides, change
ratio, improvement
LOINC 2571-8
Change in Free Fatty Acids (mmol/L) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
Free fatty acids, change
ratio, improvement
Change in Free Fatty Acids (mg/dL) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
Free fatty acids, change
ratio, improvement
Change in High-sensitivity C-reactive Protein (hsCRP) - Ratio to Baseline
Time frame:Baseline (week 0), End of treatment (week 72)
hs-CRP, change
ratio, improvement
LOINC 30522-7
Change in Pulse
Time frame:Baseline (week 0), End of treatment (week 72)
Heart rate, change
change from baseline, improvement
Safety / tolerability / PK
12 endpointsSemaglutide 7.2 mg Versus Placebo: Number of Adverse Events (AEs)
Time frame:At week 81
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (number), Events | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 1581 | — |
| Placebo | 253 | — |
Semaglutide 7.2 mg Versus Placebo: Number of Serious Adverse Events (SAEs)
Time frame:At week 81
Serious AEs (any)
event count, event
Posted result
| Group | Value (number), Events | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 39 | — |
| Placebo | 21 | — |
Semaglutide 7.2 mg Versus Placebo: Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes
Time frame:At week 81
Documented hypoglycemia
event count, event
componentsSevere hypoglycemia, Documented hypoglycemia
Posted result
| Group | Value (number), Episodes | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 0 | — |
| Placebo | 1 | — |
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of AEs
Time frame:At week 81
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (number), Events | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 1581 | — |
| Semaglutide 2.4 mg | 508 | — |
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of SAEs
Time frame:At week 81
Serious AEs (any)
event count, event
Posted result
| Group | Value (number), Events | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 39 | — |
| Semaglutide 2.4 mg | 35 | — |
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes
Time frame:At week 81
Documented hypoglycemia
event count, event
componentsSevere hypoglycemia, Documented hypoglycemia
Posted result
| Group | Value (number), Episodes | 95% CI |
|---|---|---|
| Semaglutide 7.2 mg | 0 | — |
| Semaglutide 2.4 mg | 0 | — |
Semaglutide 7.2 mg Versus Placebo: Number of Adverse Events (AEs)
Time frame:At week 81
Treatment-emergent AEs (any)
event count, event
Semaglutide 7.2 mg Versus Placebo: Number of Serious Adverse Events (SAEs)
Time frame:At week 81
Serious AEs (any)
event count, event
Semaglutide 7.2 mg Versus Placebo: Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes
Time frame:At week 81
Documented hypoglycemia
event count, event
componentsSevere hypoglycemia, Documented hypoglycemia
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of AEs
Time frame:At week 81
Treatment-emergent AEs (any)
event count, event
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of SAEs
Time frame:At week 81
Serious AEs (any)
event count, event
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes
Time frame:At week 81
Documented hypoglycemia
event count, event
componentsSevere hypoglycemia, Documented hypoglycemia
Publications (1)
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
- The lancet. Diabetes & endocrinology2025 Nov (month)PMID40961953doi:10.1016/S2213-8587(25)00225-6via clinicaltrials gov reference derived + 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.