Primary outcome
What NCT04102189 measured first
| Semaglutide 2.4 mgn=131 | Placebon=62 |
|---|---|
| -16.2(12.9) | -0.1(8.6) |
Phase 3 · Semaglutide
NCT04102189 trial results
Effect and Safety of Semaglutide 2.4 mg Once Weekly on Weight Management in Adolescents With Overweight or Obesity
Change in Body Mass Index (BMI) (Percentage [%]) (Percentage change of BMI), Baseline (week 0), week 68. Semaglutide 2.4 mg: -16.2; Placebo: -0.1.
- Participants
- 201
- Status
- completed
- Completed
- 2022-03-28
- Sponsor
- Novo Nordisk A/S
As posted on ClinicalTrials.gov (NCT04102189), updated at source Dec 11, 2025. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in NCT04102189
Percent of participants affected, From baseline (week 0) to week 75. The most common events the registry lists.
| Event | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Any serious event | 11.3% | 9% |
| Nausea | 42.1% | 17.9% |
| Vomiting | 36.1% | 10.4% |
| Diarrhoea | 21.8% | 19.4% |
| Headache | 16.5% | 16.4% |
| Abdominal pain | 15% | 6% |
| COVID-19 | 11.3% | 14.9% |
| Nasopharyngitis | 12% | 10.4% |
| Abdominal pain upper | 8.3% | 11.9% |
| Dizziness | 7.5% | 3% |
| Fatigue | 3% | 7.5% |
| Pyrexia | 3.8% | 7.5% |
| Gastroenteritis | 6.8% | 3% |
| Acne | 3% | 6% |
| Blood creatine phosphokinase increased | 0.8% | 6% |
| Constipation | 6% | 1.5% |
| Contusion | 1.5% | 6% |
| Cough | 3% | 6% |
| Decreased appetite | 6% | 4.5% |
| Dysmenorrhoea | 1.5% | 6% |
Secondary outcomes
What else it measured
| Measure | Semaglutide 2.4 mgn=131 | Placebon=62 |
|---|---|---|
| Yes | 72.5 | 17.7 |
| No | 27.5 | 82.3 |
| Semaglutide 2.4 mgn=131 | Placebon=62 |
|---|---|
| -15.7(14.6) | 2.3(9.7) |
| Semaglutide 2.4 mgn=131 | Placebon=62 |
|---|---|
| -14.8(13.2) | 2.3(9.1) |
| Measure | Semaglutide 2.4 mgn=131 | Placebon=62 |
|---|---|---|
| Yes | 61.8 | 8.1 |
| No | 38.2 | 91.9 |
| Measure | Semaglutide 2.4 mgn=131 | Placebon=62 |
|---|---|---|
| Yes | 53.4 | 4.8 |
| No | 46.6 | 95.2 |
| Measure | Semaglutide 2.4 mgn=131 | Placebon=62 |
|---|---|---|
| Yes | 37.4 | 3.2 |
| No | 62.6 | 96.8 |
| Semaglutide 2.4 mgn=131 | Placebon=62 |
|---|---|
| -24.9(17.0) | -4.5(10.5) |
| Measure | Semaglutide 2.4 mgn=131 | Placebon=62 |
|---|---|---|
| Yes | 71.8 | 21.0 |
| No | 28.2 | 79.0 |
| Semaglutide 2.4 mgn=131 | Placebon=62 |
|---|---|
| -1.1(0.9) | -0.1(0.5) |
| Semaglutide 2.4 mgn=131 | Placebon=62 |
|---|---|
| -5.9(4.9) | 0.0(3.1) |
| Semaglutide 2.4 mgn=131 | Placebon=62 |
|---|---|
| -12.7(12.2) | -0.5(6.5) |
| Measure | Semaglutide 2.4 mgn=131 | Placebon=62 |
|---|---|---|
| Yes | 75.6 | 22.6 |
| No | 24.4 | 77.4 |
The trial
How NCT04102189 was run
This study will look at the change in teenagers' body weight from the start to the end of the study. This is to compare the effect on body weight in teenagers taking semaglutide (a new medicine) and teenagers taking "dummy" medicine. The teenagers in the study and their parents will also have talks with study staff about healthy food choices, how to be more physically active and what they can do to help the teenagers lose weight. The teenagers will either get semaglutide or "dummy" medicine - which treatment is decided by chance. The teenagers will take 1 injection every week, on the same day of the week for about 15 months. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The teenagers will have 17 clinic visits, will have blood samples taken and will have to complete questionnaires and keep a diary. All this will be explained before study start.
- Semaglutide: 2.4 mg or maximum tolerated dose (MTD) injected subcutaneously (under the skin, s.c.) once weekly
- Placebo: Placebo injected s.c. once weekly .
Who could join the trial
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
Published papers
Papers from NCT04102189
- Weghuber D, Barrett T, Barrientos-Perez M, Gies I, Hesse D, Jeppesen OK, Kelly AS, Mastrandrea LD, Sorrig R, Arslanian S; STEP TEENS Investigators. Once-Weekly Semaglutide in Adolescents with Obesity. N Engl J Med. 2022 Dec 15;387(24):2245-2257. doi: 10.1056/NEJMoa2208601. Epub 2022 Nov 2.
- Kelly AS, Arslanian S, Hesse D, Iversen AT, Korner A, Schmidt S, Sorrig R, Weghuber D, Jastreboff AM. Reducing BMI below the obesity threshold in adolescents treated with once-weekly subcutaneous semaglutide 2.4 mg. Obesity (Silver Spring). 2023 Aug;31(8):2139-2149. doi: 10.1002/oby.23808. Epub 2023 Jul 9.
- Weghuber D, Boberg K, Hesse D, Jeppesen OK, Sorrig R, Kelly AS; STEP TEENS Investigators. Semaglutide treatment for obesity in teenagers: a plain language summary of the STEP TEENS research study. J Comp Eff Res. 2023 Feb;12(2):e220187. doi: 10.2217/cer-2022-0187. Epub 2022 Dec 19.
- Cuda S, Censani M. Progress in pediatric obesity: new and advanced therapies. Curr Opin Pediatr. 2022 Aug 1;34(4):407-413. doi: 10.1097/MOP.0000000000001150. Epub 2022 Jul 5.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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