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STEP TEENS Weight Maintenance: A research study on how well semaglutide helps teenagers with excess body weight to lose weight and maintain weight loss
EU CTIS ID: 2023-508055-40-00
What this study is testing
To investigate BMI maintenance with semaglutide administered according to a dose-tapering algorithm in adolescents who have achieved BMI below obesity threshold and are still on-treatment after 1.5 years of initial treatment
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 <15 years at the time of signing the informed consent
- BMI ≥95th percentile at screening (on sex- and age-specific BMI growth charts (CDC.gov))
- Body weight >60 kg at screening
You likely can't join if
- 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: - Liposuction and/or abdominoplasty, if performed >1 year prior to screening - Adjustable gastric banding, if the band has been removed >1 year prior to screening - Intragastric balloon, if the balloon has been removed >1 year prior to screening - Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed >1 year prior to screening
- Endocrine, hypothalamic, or syndromic obesity
- History of type 1 or type 2 diabetes mellitus (as declared by the participant (or by parent(s)/LAR where applicable) or reported in the participant’s medical records).
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Canada
- Mexico
- Saudi Arabia
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Canada; Mexico; Saudi Arabia; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.