BridgeMD
eHealth Based treatment of AdolescenT obesiTy with Low energy diet and sEmaglutide (eBATTLE Obesity)
EU CTIS ID: 2023-506289-29-00
What this study is testing
To confirm superiority of once-weekly semaglutide s.c. 2.4 mg versus once-weekly semaglutide s.c. placebo, both as an adjunct to a 52-week blended face-to-face (F2F) and electronic behavioral therapy (eBT) program in treatment-seeking adolescents (12 to <18 years) with obesity on percentage reduction in body weight (% BMI change) [after completion of an initial 8-week blended F2F and electronic LED (eLED)].
- 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
- Participants are eligible to be included in the study only if all of the following criteria apply: 1. Informed consent of parent(s) or legally authorized representative (LAR) of subject and assent of adolescent, 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 2. The trial participant must be above or equal to 12 years and below 18 years of age at the time of signing the informed consent. 3. Treatment seeking male and female adolescent patients with obesity (BMI ≥ IOTF 35 kg/m2) OR BMI ≥ IOTF 30 kg/m2 with at least one weight related comorbidity, risk factor or complication, as considered by the treating physician (44). 4. History of at least one self-reported unsuccessful dietary effort to lose body weight 5. Capable of giving signed informed consent as described in Appendix 3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol.
You likely can't join if
- Participants are excluded from the study if any of the following criteria apply: 1. Prepubertal patients (Tanner stage 1), self-assessed, see 8.2.1, table 1. 2. History of diabetes mellitus (type 1 or type 2) as judged by the investigator 3. Intellectual disability as judged by the investigator 4. Sub-optimal level of spoken Norwegian as judged by the investigator
The study team makes the final eligibility decision.
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.
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.