Efficacy of Semaglutide s.c. Once-weekly on Weight Loss and Management in Adolescents With
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 obesit
| Condition(s) | Monogenic Obesity |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | Inclusion Criteria: 1. Treatment with semaglutide as prescribed in routine clinical practice according to summary of product characteristics. 2. Informed consent of the patient, their parents, or legally acceptable representative (LAR) of participant and adolescent assent, as age-appropriate. 3. Age at time of signing informed consent: ≥12 to \<21 years. 4. BMI ≥95th percentile as defined on sex- and age-specific BMI growth charts (CDC.gov) 5. Body weight of \>60 kg. 6. Diagnosis of monogenic obesity by a Clinical Laboratory Improvement Amendments (CLIA)/ College of American Pathologists (CAP)/International Organisation for Standardization (ISO) 1518-certified laboratory using ACMG criteria as pathogenic (P), likely pathogenic (LP) and variant of uncertain significance (VUS). Exclusion Cri |
| Ages | 12 Years to 21 Years |
| Sex | All |
| Lead sponsor | Prof. Dr. Martin Wabitsch |
| Locations | Paris, France; Berlin, Germany; Leipzig, Germany; Ulm, Germany; Rotterdam, Netherlands; Madrid, Spain (+1 more sites) |
| Start date | 2025-12-01 |
| NCT ID | NCT07302802 |
| Official listing | https://clinicaltrials.gov/study/NCT07302802 |