NCT07302802Recruiting
Efficacy of Semaglutide s.c. Once-weekly on Weight Loss and Management in Adolescents With Monogenic Obesity in Clinical Practice
Source: ClinicalTrials.gov · Last updated 8 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 70 (estimated)
- First submitted
- 10 Dec 2025
- Start date
- 1 Dec 2025
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Prof. Dr. Martin Wabitsch
- Diseases
- Obesity
- NCT number
- NCT07302802
What you commit to
- Study type: Observational
- Planned participants: 70
- From 1 Dec 2025 to the primary completion date, 30 Jun 2028
- 7 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The safety and efficacy of Wegovy have not been investigated in patients:
- treated with other products for weight management,
- with type 1 diabetes,
- with severe renal impairment (see section 4.2),
- with severe hepatic impairment (see section 4.2),
- with congestive heart failure New York Heart Association (NYHA) class IV. Use in these patients is not recommended
Lab values
- Hypersensitivity to the active substance or to any of the excipients listed:
- Disodium phosphate, dihydrate
- Propylene glycol
- Phenol
- Hydrochloric acid (for pH adjustment)
- Sodium hydroxide (for pH adjustment)
- Water for injection
Other
- Participation in any interventional clinical trials at the time of enrolment.
- Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice)
Who the study is looking for
- Treatment with semaglutide as prescribed in routine clinical practice according to summary of product characteristics.
- Informed consent of the patient, their parents, or legally acceptable representative (LAR) of participant and adolescent assent, as age-appropriate.
- Age at time of signing informed consent: ≥12 to \<21 years.
- BMI ≥95th percentile as defined on sex- and age-specific BMI growth charts (CDC.gov)
- Body weight of \>60 kg.
- 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).
Age in the registry: 12 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute for Experimental Pediatric Endocrinology, Charité Universitätsmedizin Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Not yet recruiting |
| University Hospital for Children and Adolescents, Center for Pediatric Research, Medical Faculty, University of Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Not yet recruiting |
| Division of Paediatric Endocrinology and Diabetes, Department of Paediatrics and Adolescent Medicine, Ulm University Medical Centre Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Departments of Pediatrics & Pediatric Endocrinology, Hospital Infantil Universitario Niño Jesús, Universidad Autónoma de Madrid Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Assistance Publique-Hôpitaux de Paris (AP-HP), Trousseau Hospital Paris, Pediatric Nutrition Department Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Wellcome-MRC Institute of Metabolic Science and NIHR Cambridge Biomedical Research Centre Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Not yet recruiting |
| University Medical Center Rotterdam, Erasmus MC-Sophia Children's Hospital Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.