Studying Semaglutide to Reduce Heart Disease Risks in Children Ages 12 to 17 With Severe Obesity

What this Trial Is About

Researchers are evaluating how the drug semaglutide affects disease risk markers related to weight in children aged 12 to 15 years who are classified as obese class 2 or 3. The study aims to understand how weight loss rate, body mass index, body composition, heart structure and function, and exercise ability interact at enrollment, and how these factors and disease risk markers change over time with semaglutide treatment. The research also seeks to explore differences between males and females and identify key factors that may improve outcomes. All participants in this observational study will receive the study drug semaglutide, given according to standard care dosing. There is no randomization or placebo group. The study lasts approximately 12 months, with some flexibility based on when participants reach a maintenance dose. During the study, participants will undergo two cardiac imaging assessments either MRI scans or echocardiograms, body composition and fitness evaluations, and urine tests. Blood samples will be collected at enrollment, around 6 months, and at study end, using blood drawn during routine labs when possible. Participants will have follow-up visits with the study doctor and female participants who have started menstruation will be asked to take pregnancy tests. Researchers will monitor changes in medication use, lipid profiles, inflammatory markers, blood pressure, cardiac structure and function, dietary and exercise habits, mental health questionnaires, body measurements, metabolic rates, and various blood panels. Biological samples will be stored indefinitely with identifiers removed. The study plans to enroll about 50 patients, and participation spans approximately one year.

Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity