Phase 3
Completed N=201
A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity
Overweight · Obesity
Source: ClinicalTrials.gov NCT04102189 ↗
Enrolled (actual)
201
Serious AEs
10.5%
Results posted
Apr 2023
Primary outcomePrimary: Change in Body Mass Index (BMI) (Percentage [%]) — -16.2; -0.1 Percentage change of BMI — p=<.0001
◆ Published Evidence
Highly cited
618citations · ~155 / year
Once-Weekly Semaglutide in Adolescents with Obesity.
Summary
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.
Linked Publications (4)
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Once-Weekly Semaglutide in Adolescents with Obesity.
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Reducing BMI below the obesity threshold in adolescents treated with once-weekly subcutaneous semaglutide 2.4 mg.
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Semaglutide treatment for obesity in teenagers: a plain language summary of the STEP TEENS research study.
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Progress in pediatric obesity: new and advanced therapies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Mass Index (BMI) (Percentage [%]) |
-16.2; -0.1 | <.0001 sig |
| SECONDARY Percentage of Participants Achieving Greater Than or Equal to (>=) 5% Reduction of Body Weight (Yes/no) |
72.5; 17.7; 27.5; 82.3 | — |
| SECONDARY Change in Body Weight (Kilograms [kg]) |
-15.7; 2.3 | — |
| SECONDARY Change in Body Weight (%) |
-14.8; 2.3 | — |
| SECONDARY Percentage of Participants Achieving >=10% Reduction of Body Weight (Yes/no) |
61.8; 8.1; 38.2; 91.9 | — |
| SECONDARY Percentage of Participants Achieving >=15% Reduction of Body Weight (Yes/no) |
53.4; 4.8; 46.6; 95.2 | — |
| SECONDARY Percentage of Participants Achieving >=20% Reduction of Body Weight (Yes/no) |
37.4; 3.2; 62.6; 96.8 | — |
| SECONDARY Change in BMI Percentage of the 95th Percentile on Gender and Age-specific Growth Charts (CDC.Gov [CDC: {Centers for Disease Control and Prevention}]) |
-24.9; -4.5 | — |
| SECONDARY Percentage of Participants Achieving Improvement in Weight Category (Yes/no) |
71.8; 21.0; 28.2; 79.0 | — |
| SECONDARY Change in BMI (Standard Deviation Score [SDS]) |
-1.1; -0.1 | — |
| SECONDARY Change in BMI (Kilograms Per Meter Square [kg/m^2]) |
-5.9; 0.0 | — |
| SECONDARY Change in Waist Circumference |
-12.7; -0.5 | — |
| SECONDARY Percentage of Participants Achieving >=5% Reduction of BMI (Yes/no) |
75.6; 22.6; 24.4; 77.4 | — |
| SECONDARY Change in Systolic Blood Pressure |
-3; -1 | — |
| SECONDARY Change in Diastolic Blood Pressure |
-2; -1 | — |
| SECONDARY Change in Glycated Haemoglobin (HbA1c) (%) |
-0.4; -0.1 | — |
| SECONDARY Change in HbA1c (Millimoles Per Mole [mmol/Mol]) |
-4.2; -1.2 | — |
| SECONDARY Change in Fasting Plasma Glucose (Millimoles Per Liter [mmol/L]) |
-0.2; 0.0 | — |
| SECONDARY Change in Fasting Plasma Glucose (Milligrams Per Deciliter [mg/dL]) |
-4.2; 0.0 | — |
| SECONDARY Change in Fasting Insulin (Picomoles Per Liter [Pmol/L]): Ratio to Baseline |
0.64; 0.99 | — |
| SECONDARY Change in Fasting Insulin (Milli International Units Per Milliliter [mIU/mL]): Ratio to Baseline |
0.64; 0.99 | — |
| SECONDARY Change in Total Cholesterol (mmol/L): Ratio to Baseline |
0.92; 0.98 | — |
| SECONDARY Change in Total Cholesterol (mg/dL): Ratio to Baseline |
0.92; 0.98 | — |
| SECONDARY Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L): Ratio to Baseline |
1.08; 1.03 | — |
| SECONDARY Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL): Ratio to Baseline |
1.08; 1.03 | — |
| SECONDARY Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L): Ratio to Baseline |
0.91; 0.96 | — |
| SECONDARY Change in LDL Cholesterol (mg/dL): Ratio to Baseline |
0.91; 0.96 | — |
| SECONDARY Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mmol/L): Ratio to Baseline |
0.71; 1.03 | — |
| SECONDARY Change in VLDL Cholesterol (mg/dL): Ratio to Baseline |
0.71; 1.03 | — |
| SECONDARY Change in Triglycerides (mmol/L): Ratio to Baseline |
0.71; 1.04 | — |
| SECONDARY Change in Triglycerides (mg/dL): Ratio to Baseline |
0.71; 1.04 | — |
| SECONDARY Change in Alanine Aminotransferase (ALT): Ratio to Baseline |
0.79; 1.00 | — |
| SECONDARY Number of Treatment-emergent Adverse Events (TEAEs) |
792; 328 | — |
| SECONDARY Number of Treatment-emergent Serious Adverse Events (SAEs) |
17; 7 | — |
| SECONDARY Change in Pulse |
0; -1 | — |
| SECONDARY Change in Amylase: Ratio to Baseline |
1.15; 1.04 | — |
| SECONDARY Change in Lipase: Ratio to Baseline |
1.39; 1.12 | — |
| SECONDARY Change in Calcitonin: Ratio to Baseline |
1.14; 1.09 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04102189) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.