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Protocol for a randomised, double-blinded, controlled trial of youth with childhood-onset obesity treated with semaglutide 2.4 mg/week: the RESETTLE trial
Testing weekly semaglutide treatment in young people with early-onset obesity: the RESETTLE trial
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Abstract
Expected enrollment is 180-270 young adults aged 18-28 years with obesity following hospital-based care.
- The study investigates as an add-on treatment for young adults who did not achieve adequate weight reduction from previous obesity management.
- Participants are grouped based on their previous treatment response, with specific criteria for low, medium, and high treatment responses.
- Participants with a body mass index (BMI) of 30 kg/m or greater will receive either semaglutide 2.4 mg/week or a placebo for 68 weeks.
- The primary outcome measures the change in BMI from the start of treatment to the end of the study.
- Secondary outcomes include changes in weight and body composition.
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Key numbers
180-270
Expected participant range
Participants aged 18-28 years with childhood-onset obesity.
2.4 mg/week
dosage
Weekly subcutaneous injection as an add-on to existing obesity care.
68 weeks
Duration of treatment
Length of the treatment phase for participants receiving or .