← Trials/Trial dossier/NCT04102189

CompletedPhase 3Results posted

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

Novo Nordisk A/S

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

NCT IDNCT04102189
Org study IDNN9536-4451
Secondary ID2018-002431-18
Secondary IDU1111-1215-7560World Health Organization (WHO)

Timeline

Milestones

Study first posted2019-09-25actual
Study start2019-10-07actual
Primary completion2022-03-25actual
Study completion2022-03-28actual
Results first posted2023-04-18actual
Last update posted2025-12-11actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age12 Years
Maximum age17 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Informed consent of parent(s) or legally acceptable representative of subject and child assent, as appropriate obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Male or female, ages 12 to below 18 years at the time of signing informed consent
BMI equal to or above 95th percentile OR equal to or above 85th percentile (on gender and age-specific growth charts (CDC.gov)) with 1 or more weight related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or type 2 diabetes
History of at least one self-reported unsuccessful dietary effort to lose weight

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

Prepubertal subjects (Tanner stage 1)
History of type 1 diabetes
A self-reported (or by parent(s)/legally acceptable representative where applicable) change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Subjects with secondary causes of obesity (i.e., hypothalamic, monogenic or endocrine causes)
For subjects with type 2 diabetes only: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

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
Cardiometabolic biomarkers
26
Glycemic / diabetes
12
Safety / tolerability / PK
10
MASH / liver
2

Weight & body composition

26 endpoints
Primary/registry result

Change in Body Mass Index (BMI) (Percentage [%])

Time frame:Baseline (week 0), week 68

BMI, change

percent change from baseline, improvement

Posted result

GroupValue (mean), Percentage change of BMI95% CI
Semaglutide 2.4 mg-16.2
Placebo-0.1
Treatment difference-16.7595% CI-20.27-13.23p<.0001ANCOVA
Primary/protocol endpoint

Change in Body Mass Index (BMI) (Percentage [%])

Time frame:Baseline (week 0), week 68

BMI, change

percent change from baseline, improvement

Secondary/registry result

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

GroupValue (number), Percentage of participants95% CI
Semaglutide 2.4 mgYes72.5
No27.5
PlaceboYes17.7
No82.3
Secondary/registry result

Change in Body Weight (Kilograms [kg])

Time frame:Baseline (week 0), week 68

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), kg95% CI
Semaglutide 2.4 mg-15.7
Placebo2.3
Secondary/registry result

Change in Body Weight (%)

Time frame:Baseline (week 0), week 68

Body weight, % change

percent change from baseline, improvement

Posted result

GroupValue (mean), Percentage change of body weight95% CI
Semaglutide 2.4 mg-14.8
Placebo2.3
Secondary/registry result

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

GroupValue (number), Percentage of participants95% CI
Semaglutide 2.4 mgYes61.8
No38.2
PlaceboYes8.1
No91.9
Secondary/registry result

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

GroupValue (number), Percentage of participants95% CI
Semaglutide 2.4 mgYes53.4
No46.6
PlaceboYes4.8
No95.2
Secondary/registry result

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

GroupValue (number), Percentage of participants95% CI
Semaglutide 2.4 mgYes37.4
No62.6
PlaceboYes3.2
No96.8
Secondary/registry result

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

GroupValue (mean), Percentage point of BMI95% CI
Semaglutide 2.4 mg-24.9
Placebo-4.5
Secondary/registry result

Percentage of Participants Achieving Improvement in Weight Category (Yes/no)

Time frame:At week 68

categorical status, improvement

Posted result

GroupValue (number), Percentage of participants95% CI
Semaglutide 2.4 mgYes71.8
No28.2
PlaceboYes21.0
No79.0
Secondary/registry result

Change in BMI (Standard Deviation Score [SDS])

Time frame:Baseline (week 0), week 68

BMI SDS, change

change from baseline, improvement

Posted result

GroupValue (mean), standard deviation score95% CI
Semaglutide 2.4 mg-1.1
Placebo-0.1
Secondary/registry result

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

GroupValue (mean), kg/m^295% CI
Semaglutide 2.4 mg-5.9
Placebo0.0
Secondary/registry result

Change in Waist Circumference

Time frame:Baseline (week 0), week 68

Waist circumference, change

change from baseline, improvement

Posted result

GroupValue (mean), cm95% CI
Semaglutide 2.4 mg-12.7
Placebo-0.5
Secondary/registry result

Percentage of Participants Achieving >=5% Reduction of BMI (Yes/no)

Time frame:At week 68

threshold achievement, improvement

Posted result

GroupValue (number), Percentage of participants95% CI
Semaglutide 2.4 mgYes75.6
No24.4
PlaceboYes22.6
No77.4
Secondary/protocol endpoint

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

Secondary/protocol endpoint

Change 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 in Body Weight (%)

Time frame:Baseline (week 0), week 68

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving >=10% Reduction of Body Weight (Yes/no)

Time frame:At week 68

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving >=15% Reduction of Body Weight (Yes/no)

Time frame:At week 68

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving >=20% Reduction of Body Weight (Yes/no)

Time frame:At week 68

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Percentage of Participants Achieving Improvement in Weight Category (Yes/no)

Time frame:At week 68

categorical status, improvement

Secondary/protocol endpoint

Change in BMI (Standard Deviation Score [SDS])

Time frame:Baseline (week 0), week 68

BMI SDS, change

change from baseline, improvement

Secondary/protocol endpoint

Change in BMI (Kilograms Per Meter Square [kg/m^2])

Time frame:Baseline (week 0), week 68

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Baseline (week 0), week 68

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percentage of Participants Achieving >=5% Reduction of BMI (Yes/no)

Time frame:At week 68

threshold achievement, improvement

Glycemic / diabetes

12 endpoints
Secondary/registry result

Change in Glycated Haemoglobin (HbA1c) (%)

Time frame:Baseline (week 0), week 68

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), Percentage of HbA1c95% CI
Semaglutide 2.4 mg-0.4
Placebo-0.1
Secondary/registry result

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

GroupValue (mean), mmol/mol95% CI
Semaglutide 2.4 mg-4.2
Placebo-1.2
Secondary/registry result

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

GroupValue (mean), mmol/L95% CI
Semaglutide 2.4 mg-0.2
Placebo0.0
Secondary/registry result

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

GroupValue (mean), mg/dL95% CI
Semaglutide 2.4 mg-4.2
Placebo0.0
Secondary/registry result

Change in Fasting Insulin (Picomoles Per Liter [Pmol/L]): Ratio to Baseline

Time frame:Baseline (week 0), week 68

ratio, improvement

Posted result

GroupValue (geometric_mean), Ratio of fasting insulin95% CI
Semaglutide 2.4 mg0.64
Placebo0.99
Secondary/registry result

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

GroupValue (geometric_mean), Ratio of fasting insulin95% CI
Semaglutide 2.4 mg0.64
Placebo0.99
Secondary/protocol endpoint

Change in Glycated Haemoglobin (HbA1c) (%)

Time frame:Baseline (week 0), week 68

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in 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 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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Change in Fasting Insulin (Picomoles Per Liter [Pmol/L]): Ratio to Baseline

Time frame:Baseline (week 0), week 68

ratio, improvement

Secondary/protocol endpoint

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 endpoints
Secondary/registry result

Change in Alanine Aminotransferase (ALT): Ratio to Baseline

Time frame:Baseline (week 0), week 68

ALT, change

ratio, improvement

LOINC 1742-6

Posted result

GroupValue (geometric_mean), Ratio of ALT95% CI
Semaglutide 2.4 mg0.79
Placebo1.00
Secondary/protocol endpoint

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 endpoints
Secondary/registry result

Change in Systolic Blood Pressure

Time frame:Baseline (week 0), week 68

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

GroupValue (mean), millimeters of mercury (mmHg)95% CI
Semaglutide 2.4 mg-3
Placebo-1
Secondary/registry result

Change in Diastolic Blood Pressure

Time frame:Baseline (week 0), week 68

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

GroupValue (mean), mmHg95% CI
Semaglutide 2.4 mg-2
Placebo-1
Secondary/registry result

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

GroupValue (geometric_mean), Ratio of total cholesterol95% CI
Semaglutide 2.4 mg0.92
Placebo0.98
Secondary/registry result

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

GroupValue (geometric_mean), Ratio of total cholesterol95% CI
Semaglutide 2.4 mg0.92
Placebo0.98
Secondary/registry result

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

GroupValue (geometric_mean), Ratio of HDL cholesterol95% CI
Semaglutide 2.4 mg1.08
Placebo1.03
Secondary/registry result

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

GroupValue (geometric_mean), Ratio of HDL cholesterol95% CI
Semaglutide 2.4 mg1.08
Placebo1.03
Secondary/registry result

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

GroupValue (geometric_mean), Ratio of LDL cholesterol95% CI
Semaglutide 2.4 mg0.91
Placebo0.96
Secondary/registry result

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

GroupValue (geometric_mean), Ratio of LDL cholesterol95% CI
Semaglutide 2.4 mg0.91
Placebo0.96
Secondary/registry result

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

GroupValue (geometric_mean), Ratio of VLDL cholesterol95% CI
Semaglutide 2.4 mg0.71
Placebo1.03
Secondary/registry result

Change in VLDL Cholesterol (mg/dL): Ratio to Baseline

Time frame:Baseline (week 0), week 68

VLDL, change

ratio, improvement

Posted result

GroupValue (geometric_mean), Ratio of VLDL cholesterol95% CI
Semaglutide 2.4 mg0.71
Placebo1.03
Secondary/registry result

Change in Triglycerides (mmol/L): Ratio to Baseline

Time frame:Baseline (week 0), week 68

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

GroupValue (geometric_mean), Ratio of triglycerides95% CI
Semaglutide 2.4 mg0.71
Placebo1.04
Secondary/registry result

Change in Triglycerides (mg/dL): Ratio to Baseline

Time frame:Baseline (week 0), week 68

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

GroupValue (geometric_mean), Ratio of triglycerides95% CI
Semaglutide 2.4 mg0.71
Placebo1.04
Secondary/registry result

Change in Pulse

Time frame:Baseline (week 0), week 68

Heart rate, change

change from baseline, improvement

Posted result

GroupValue (mean), Beats per minute (beats/min)95% CI
Semaglutide 2.4 mg0
Placebo-1
Secondary/protocol endpoint

Change 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 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 in Total Cholesterol (mmol/L): Ratio to Baseline

Time frame:Baseline (week 0), week 68

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in Total Cholesterol (mg/dL): Ratio to Baseline

Time frame:Baseline (week 0), week 68

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Change in 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 in 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 in VLDL Cholesterol (mg/dL): Ratio to Baseline

Time frame:Baseline (week 0), week 68

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change in Triglycerides (mmol/L): Ratio to Baseline

Time frame:Baseline (week 0), week 68

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Triglycerides (mg/dL): Ratio to Baseline

Time frame:Baseline (week 0), week 68

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Pulse

Time frame:Baseline (week 0), week 68

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 75

Treatment-emergent AEs (any)

event count, event

Posted result

GroupValue (number), Events95% CI
Semaglutide 2.4 mg792
Placebo328
Secondary/registry result

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

GroupValue (number), Events95% CI
Semaglutide 2.4 mg17
Placebo7
Secondary/registry result

Change in Amylase: Ratio to Baseline

Time frame:Baseline (week 0), week 68

ratio, descriptive

Posted result

GroupValue (geometric_mean), Ratio of amylase95% CI
Semaglutide 2.4 mg1.15
Placebo1.04
Secondary/registry result

Change in Lipase: Ratio to Baseline

Time frame:Baseline (week 0), week 68

ratio, descriptive

Posted result

GroupValue (geometric_mean), Ratio of lipase95% CI
Semaglutide 2.4 mg1.39
Placebo1.12
Secondary/registry result

Change in Calcitonin: Ratio to Baseline

Time frame:Baseline (week 0), week 68

Thyroid event

ratio, descriptive

Posted result

GroupValue (geometric_mean), Ratio of calcitonin95% CI
Semaglutide 2.4 mg1.14
Placebo1.09
Secondary/protocol endpoint

Number of Treatment-emergent Adverse Events (TEAEs)

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

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment-emergent Serious Adverse Events (SAEs)

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

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Change in Amylase: Ratio to Baseline

Time frame:Baseline (week 0), week 68

ratio, descriptive

Secondary/protocol endpoint

Change in Lipase: Ratio to Baseline

Time frame:Baseline (week 0), week 68

ratio, descriptive

Secondary/protocol endpoint

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

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.