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Recruiting Observational

Efficacy of Semaglutide s.c. Once-weekly on Weight Loss and Management in Adolescents With Monogenic Obesity in Clinical Practice

NCT07302802 · tracked via the Priya Life Science France tracker
Sponsor
Prof. Dr. Martin Wabitsch
Phase
Observational
Started
2025-12-01
Last updated
2026-01-08

Condition(s) studied

Monogenic Obesity

Investigational drug(s) / intervention(s)

Semaglutide (administered by PDS290 pen-injector) →

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

Sex
ALL
Min age
12 Years
Max age
21 Years
Healthy volunteers
No
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 Criteria: 1. Participation in any interventional clinical trials at the time of enrolment. 2. Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice) 3. 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 4. 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

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)

FacilityCityRegionStatus
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
Official registry record

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