Efficacy of Semaglutide s.c. Once-weekly on Weight Loss and Management in Adolescents With Monogenic Obesity in Clinical Practice
Condition(s) studied
Investigational drug(s) / intervention(s)
Semaglutide (administered by PDS290 pen-injector): Treatment with semaglutide as prescribed in routine clinical practice according to summary of product characteristics. The use of semaglutide can be categorised into two groups during enrolment period: 1. new users, or 2. current users (e.g., those continuing semaglutide treatment prescribed in routine clinical practice).
Study summary
This observational study aims to assess the effect of once-weekly s.c. semaglutide 2.4 mg as an adjunct to a calorie-reduced diet and increased physical activity on weight loss, change in hunger, body composition, depression, and quality of life after 68 weeks of treatment in adolescents diagnosed with monogenic obesity in routine clinical care.
Eligibility
Primary outcome measure(s)
- Proportion of participants achieving ≥10% BMI reduction from baseline (week 0) to week 68. — 68 weeks
The study evaluates the effect of once-weekly subcutaneous (s.c.) semaglutide 2.4 mg administered as an adjunct to a calorie-reduced diet and increased physical activity in adolescents diagnosed with monogenic obesity. This measure focuses on weight loss effectiveness, with the goal of assessing the impact of the treatment on BMI reduction in a real-world clinical setting after 68 weeks of treatment. The study aims to provide insight into the potential of semaglutide in managing weight in this specific patient population.
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| Assistance Publique-Hôpitaux de Paris (AP-HP), Trousseau Hospital Paris, Pediatric Nutrition Department | Paris | France | Not Yet Recruiting |
| Institute for Experimental Pediatric Endocrinology, Charité Universitätsmedizin Berlin | Berlin | Germany | Not Yet Recruiting |
| University Hospital for Children and Adolescents, Center for Pediatric Research, Medical Faculty, University of Leipzig | Leipzig | Germany | Not Yet Recruiting |
| Division of Paediatric Endocrinology and Diabetes, Department of Paediatrics and Adolescent Medicine, Ulm University Medical Centre | Ulm | Germany | Recruiting |
| University Medical Center Rotterdam, Erasmus MC-Sophia Children's Hospital | Rotterdam | Netherlands | Not Yet Recruiting |
| Departments of Pediatrics & Pediatric Endocrinology, Hospital Infantil Universitario Niño Jesús, Universidad Autónoma de Madrid | Madrid | Spain | Not Yet Recruiting |
| Wellcome-MRC Institute of Metabolic Science and NIHR Cambridge Biomedical Research Centre | Cambridge | United Kingdom | Not Yet Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07302802 on ClinicalTrials.gov ↗ ← All trials in France