Clinical trial

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

Active, not recruiting · Phase 4 · 8 countries · Registry ID NCT06571383

Active, not recruitingPhase 4Interventional

What this study is about

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. All participants will get semaglutide treatment for a minimum of 3 years.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age12 Years to 15 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity

Full registry criteria

Inclusion criteria: * 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: 1. The parent(s) or legally acceptable representative (LAR) of the participant must sign and date the Informed Consent Form, according to local requirements 2. 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 * Body weight greater than 60 kg at screening Exclusion criteria: * 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: 1. Liposuction and/or abdominoplasty, if performed more than 1 year prior to screening 2. Adjustable gastric banding, if the band has been removed more than 1 year prior to screening 3. Intragastric balloon, if the balloon has been removed more than 1 year prior to screening 4. Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed more than 1 year prior to screening * Endocrine, hypothalamic, or syndromic obesity * History of type 1 or type 2 diabetes mellitus

Treatments and study arms

Semaglutide

Drug

Participants will receive semaglutide s.c(under the skin) once weekly.

Primary outcomes

Maintenance of Body Mass Index (BMI) below obesity thresholdFrom 1.5 years to 3 years

Measures as count of participants

Study locations

93 locations were listed when this page was built. The first 40 are shown.

Cliniques universitaires Saint-Luc🇧🇪 Brussels, Belgium