STEP TEENS Weight Maintenance: A Research Study on How Well Semaglutide Helps Teenagers With Excess Body Weight to Lose Weight and Maintain Weight Loss

What Was Tested

In this phase 4 trial, researchers set out to test Semaglutide for fat loss, obesity & body recomposition.

The study is testing how well semaglutide can help adolescents with excess body weight to lose weight and to maintain weight loss.

All participants in the study will receive semaglutide as a weekly injection.

The study medicine is injected with a thin needle in the stomach, thighs or upper arms.

It had 1 arm (groups): Semaglutide (experimental).

The registry classes the interventions as drug.

Who Took Part

500 planned participants were the target.

It was open to people of any sex aged from 12 years up to 15 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study:. The parent(s) or legally acceptable representative (LAR) of the participant must sign and date the Informed Consent Form, according to local requirements. The participant must sign and date the Child Assent Form or provide oral assent, according to local requirements. Age 12 to less than 15 years at the time of signing the informed consent. BMI greater than or equal to 95th percentile at screening.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: prepubertal status (tanner stage 1); treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening; previous or planned (during the study period) obesity treatment with surgery or a weight loss device. however, the following are allowed:.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Semaglutide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2024-09-17 with completion listed for 2028-11-15.

It ran at 93 sites in United States (26), Germany (9), Canada (8), Poland (8), United Kingdom (7) and France (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Maintenance of Body Mass Index (BMI) below obesity threshold (time frame: From 1.5 years to 3 years).

It also tracked 20 secondary outcomes, for example Achieving Body Mass Index (BMI) below obesity threshold, Change in Body Mass Index (BMI), Body Mass Index (BMI) percentage of the 95th percentile, Change in Body Mass Index Standard Deviation Score (BMI SDS), Change in waist-to-height ratio (waist [cm]/ height [cm]) and Change in waist circumference.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Semaglutide in 500 people with fat loss, obesity & body recomposition.

With 500 participants it is a large trial for this field.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, Fat loss, obesity & body recomposition research.