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A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity
Effect and Safety of Semaglutide 2.4 mg Once Weekly on Weight Management in Adolescents With Overweight or Obesity
Lead sponsor
Asset
Semaglutide
Subcutaneous · GLP-1 agonist
Listed sites
51
Recruiting sites
—
Enrollment
201
actual
Study population
Obesity / overweight
Key I/E criteria
•HbA1c ≤10%•Age 12-17
Primary endpoint
•BMI, 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
For subjects with type 2 diabetes at screening the following inclusion criteria apply in addition:
- HbA1c equal to or below 10.0% (86 mmol/mol) as measured by central laboratory at screening
Exclusion criteria
Endpoints (76)
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
26 endpointsChange in Body Mass Index (BMI) (Percentage [%])
Time frame:Baseline (week 0), week 68
BMI, change
percent change from baseline, improvement
Posted result
| Group | Value (mean), Percentage change of BMI | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | -16.2 | — |
| Placebo | -0.1 | — |
Change in Body Mass Index (BMI) (Percentage [%])
Time frame:Baseline (week 0), week 68
BMI, change
percent change from baseline, improvement
Percentage of Participants Achieving Greater Than or Equal to (>=) 5% Reduction of Body Weight (Yes/no)
Time frame:At week 68
≥5% weight-loss responders
threshold achievement, improvement
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 2.4 mgYes | 72.5 | — |
| No | 27.5 | — |
| PlaceboYes | 17.7 | — |
| No | 82.3 | — |
Change 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), kg | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | -15.7 | — |
| Placebo | 2.3 | — |
Change in Body Weight (%)
Time frame:Baseline (week 0), week 68
Body weight, % change
percent change from baseline, improvement
Posted result
| Group | Value (mean), Percentage change of body weight | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | -14.8 | — |
| Placebo | 2.3 | — |
Percentage of Participants Achieving >=10% Reduction of Body Weight (Yes/no)
Time frame:At week 68
≥10% weight-loss responders
threshold achievement, improvement
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 2.4 mgYes | 61.8 | — |
| No | 38.2 | — |
| PlaceboYes | 8.1 | — |
| No | 91.9 | — |
Percentage of Participants Achieving >=15% Reduction of Body Weight (Yes/no)
Time frame:At week 68
≥15% weight-loss responders
threshold achievement, improvement
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 2.4 mgYes | 53.4 | — |
| No | 46.6 | — |
| PlaceboYes | 4.8 | — |
| No | 95.2 | — |
Percentage of Participants Achieving >=20% Reduction of Body Weight (Yes/no)
Time frame:At week 68
≥20% weight-loss responders
threshold achievement, improvement
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 2.4 mgYes | 37.4 | — |
| No | 62.6 | — |
| PlaceboYes | 3.2 | — |
| No | 96.8 | — |
Change in BMI Percentage of the 95th Percentile on Gender and Age-specific Growth Charts (CDC.Gov [CDC: {Centers for Disease Control and Prevention}])
Time frame:Baseline (week 0), week 68
change from baseline, improvement
Posted result
| Group | Value (mean), Percentage point of BMI | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | -24.9 | — |
| Placebo | -4.5 | — |
Percentage of Participants Achieving Improvement in Weight Category (Yes/no)
Time frame:At week 68
categorical status, improvement
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 2.4 mgYes | 71.8 | — |
| No | 28.2 | — |
| PlaceboYes | 21.0 | — |
| No | 79.0 | — |
Change in BMI (Standard Deviation Score [SDS])
Time frame:Baseline (week 0), week 68
BMI SDS, change
change from baseline, improvement
Posted result
| Group | Value (mean), standard deviation score | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | -1.1 | — |
| Placebo | -0.1 | — |
Change in BMI (Kilograms Per Meter Square [kg/m^2])
Time frame:Baseline (week 0), week 68
BMI, change
change from baseline, improvement
Posted result
| Group | Value (mean), kg/m^2 | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | -5.9 | — |
| Placebo | 0.0 | — |
Change in Waist Circumference
Time frame:Baseline (week 0), week 68
Waist circumference, change
change from baseline, improvement
Posted result
| Group | Value (mean), cm | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | -12.7 | — |
| Placebo | -0.5 | — |
Percentage of Participants Achieving >=5% Reduction of BMI (Yes/no)
Time frame:At week 68
threshold achievement, improvement
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Semaglutide 2.4 mgYes | 75.6 | — |
| No | 24.4 | — |
| PlaceboYes | 22.6 | — |
| No | 77.4 | — |
Percentage of Participants Achieving Greater Than or Equal to (>=) 5% Reduction of Body Weight (Yes/no)
Time frame:At week 68
≥5% weight-loss responders
threshold achievement, improvement
Change in Body Weight (Kilograms [kg])
Time frame:Baseline (week 0), week 68
Body weight, absolute change (kg)
change from baseline, improvement
Change in Body Weight (%)
Time frame:Baseline (week 0), week 68
Body weight, % change
percent change from baseline, improvement
Percentage of Participants Achieving >=10% Reduction of Body Weight (Yes/no)
Time frame:At week 68
≥10% weight-loss responders
threshold achievement, improvement
Percentage of Participants Achieving >=15% Reduction of Body Weight (Yes/no)
Time frame:At week 68
≥15% weight-loss responders
threshold achievement, improvement
Percentage of Participants Achieving >=20% Reduction of Body Weight (Yes/no)
Time frame:At week 68
≥20% weight-loss responders
threshold achievement, improvement
Change in BMI Percentage of the 95th Percentile on Gender and Age-specific Growth Charts (CDC.Gov [CDC: {Centers for Disease Control and Prevention}])
Time frame:Baseline (week 0), week 68
change from baseline, improvement
Percentage of Participants Achieving Improvement in Weight Category (Yes/no)
Time frame:At week 68
categorical status, improvement
Change in BMI (Standard Deviation Score [SDS])
Time frame:Baseline (week 0), week 68
BMI SDS, change
change from baseline, improvement
Change in BMI (Kilograms Per Meter Square [kg/m^2])
Time frame:Baseline (week 0), week 68
BMI, change
change from baseline, improvement
Change in Waist Circumference
Time frame:Baseline (week 0), week 68
Waist circumference, change
change from baseline, improvement
Percentage of Participants Achieving >=5% Reduction of BMI (Yes/no)
Time frame:At week 68
threshold achievement, improvement
Glycemic / diabetes
12 endpointsChange 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), Percentage of HbA1c | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | -0.4 | — |
| Placebo | -0.1 | — |
Change in 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 | -4.2 | — |
| Placebo | -1.2 | — |
Change in Fasting Plasma Glucose (Millimoles Per Liter [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 | -0.2 | — |
| Placebo | 0.0 | — |
Change in Fasting Plasma Glucose (Milligrams Per Deciliter [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 | -4.2 | — |
| Placebo | 0.0 | — |
Change in Fasting 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 insulin | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 0.64 | — |
| Placebo | 0.99 | — |
Change in Fasting Insulin (Milli International Units Per Milliliter [mIU/mL]): Ratio to Baseline
Time frame:Baseline (week 0), week 68
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of fasting insulin | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 0.64 | — |
| Placebo | 0.99 | — |
Change in Glycated Haemoglobin (HbA1c) (%)
Time frame:Baseline (week 0), week 68
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in HbA1c (Millimoles Per Mole [mmol/Mol])
Time frame:Baseline (week 0), week 68
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in Fasting Plasma Glucose (Millimoles Per Liter [mmol/L])
Time frame:Baseline (week 0), week 68
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change in Fasting Plasma Glucose (Milligrams Per Deciliter [mg/dL])
Time frame:Baseline (week 0), week 68
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change in Fasting Insulin (Picomoles Per Liter [Pmol/L]): Ratio to Baseline
Time frame:Baseline (week 0), week 68
ratio, improvement
Change in Fasting Insulin (Milli International Units Per Milliliter [mIU/mL]): Ratio to Baseline
Time frame:Baseline (week 0), week 68
ratio, improvement
MASH / liver
2 endpointsChange in Alanine Aminotransferase (ALT): Ratio to Baseline
Time frame:Baseline (week 0), week 68
ALT, change
ratio, improvement
LOINC 1742-6
Posted result
| Group | Value (geometric_mean), Ratio of ALT | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 0.79 | — |
| Placebo | 1.00 | — |
Change in Alanine Aminotransferase (ALT): Ratio to Baseline
Time frame:Baseline (week 0), week 68
ALT, change
ratio, improvement
LOINC 1742-6
Cardiometabolic biomarkers
26 endpointsChange 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 | -3 | — |
| Placebo | -1 | — |
Change 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 | -2 | — |
| Placebo | -1 | — |
Change in Total Cholesterol (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 | — |
| Placebo | 0.98 | — |
Change in Total Cholesterol (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 | — |
| Placebo | 0.98 | — |
Change in 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 | 1.08 | — |
| Placebo | 1.03 | — |
Change in 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 | 1.08 | — |
| Placebo | 1.03 | — |
Change in 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 | 0.91 | — |
| Placebo | 0.96 | — |
Change in 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 | 0.91 | — |
| Placebo | 0.96 | — |
Change in 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 | 0.71 | — |
| Placebo | 1.03 | — |
Change in 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 | 0.71 | — |
| Placebo | 1.03 | — |
Change in 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 | 0.71 | — |
| Placebo | 1.04 | — |
Change in 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 | 0.71 | — |
| Placebo | 1.04 | — |
Change in Pulse
Time frame:Baseline (week 0), week 68
Heart rate, change
change from baseline, improvement
Posted result
| Group | Value (mean), Beats per minute (beats/min) | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 0 | — |
| Placebo | -1 | — |
Change in Systolic Blood Pressure
Time frame:Baseline (week 0), week 68
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Change in Diastolic Blood Pressure
Time frame:Baseline (week 0), week 68
Diastolic BP, change
change from baseline, improvement
LOINC 8462-4
Change in Total Cholesterol (mmol/L): Ratio to Baseline
Time frame:Baseline (week 0), week 68
Total cholesterol, change
ratio, improvement
LOINC 2093-3
Change in Total Cholesterol (mg/dL): Ratio to Baseline
Time frame:Baseline (week 0), week 68
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), week 68:
HDL-C, change
ratio, improvement
LOINC 2085-9
Change in 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
Change in 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
Change in LDL Cholesterol (mg/dL): Ratio to Baseline
Time frame:Baseline (week 0), week 68:
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), week 68
VLDL, change
ratio, improvement
Change in VLDL Cholesterol (mg/dL): Ratio to Baseline
Time frame:Baseline (week 0), week 68
VLDL, change
ratio, improvement
Change in Triglycerides (mmol/L): Ratio to Baseline
Time frame:Baseline (week 0), week 68
Triglycerides, change
ratio, improvement
LOINC 2571-8
Change in Triglycerides (mg/dL): Ratio to Baseline
Time frame:Baseline (week 0), week 68
Triglycerides, change
ratio, improvement
LOINC 2571-8
Change in Pulse
Time frame:Baseline (week 0), week 68
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 75
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (number), Events | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 792 | — |
| Placebo | 328 | — |
Number of Treatment-emergent Serious Adverse Events (SAEs)
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 | 17 | — |
| Placebo | 7 | — |
Change in Amylase: Ratio to Baseline
Time frame:Baseline (week 0), week 68
ratio, descriptive
Posted result
| Group | Value (geometric_mean), Ratio of amylase | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 1.15 | — |
| Placebo | 1.04 | — |
Change in Lipase: Ratio to Baseline
Time frame:Baseline (week 0), week 68
ratio, descriptive
Posted result
| Group | Value (geometric_mean), Ratio of lipase | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 1.39 | — |
| Placebo | 1.12 | — |
Change in Calcitonin: Ratio to Baseline
Time frame:Baseline (week 0), week 68
Thyroid event
ratio, descriptive
Posted result
| Group | Value (geometric_mean), Ratio of calcitonin | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg | 1.14 | — |
| Placebo | 1.09 | — |
Number of Treatment-emergent Adverse Events (TEAEs)
Time frame:From baseline (week 0) to week 75
Treatment-emergent AEs (any)
event count, event
Number of Treatment-emergent Serious Adverse Events (SAEs)
Time frame:From baseline (week 0) to week 75
Serious AEs (any)
event count, event
Change in Amylase: Ratio to Baseline
Time frame:Baseline (week 0), week 68
ratio, descriptive
Change in Lipase: Ratio to Baseline
Time frame:Baseline (week 0), week 68
ratio, descriptive
Change in Calcitonin: Ratio to Baseline
Time frame:Baseline (week 0), week 68
Thyroid event
ratio, descriptive
Publications (7)
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
- Obesity (Silver Spring, Md.)2023 Aug (month)PMID37196421doi:10.1002/oby.23808via clinicaltrials gov reference derived + pubmed nct search
- Journal of comparative effectiveness research2023 Feb (month)PMID36534451doi:10.2217/cer-2022-0187via clinicaltrials gov reference derived + pubmed nct search
- The New England journal of medicine2022 Dec 15PMID36322838doi:10.1056/NEJMoa2208601via CT.gov reference + pubmed nct search
- Current opinion in pediatrics2022 Aug 1PMID35797460doi:10.1097/MOP.0000000000001150via clinicaltrials gov reference derived + pubmed nct search
- Orphanet journal of rare diseases2021 Jun 14PMID34127036doi:10.1186/s13023-021-01911-4via 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.