Efficacy of Semaglutide s.c. Once-weekly on Weight Loss and Management in Adolescents With Monogenic Obesity in Clinical Practice
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 21
Healthy Volunteers: f
View:
• 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).
Locations
Other Locations
France
Assistance Publique-Hôpitaux de Paris (AP-HP), Trousseau Hospital Paris, Pediatric Nutrition Department
NOT_YET_RECRUITING
Paris
Germany
Institute for Experimental Pediatric Endocrinology, Charité Universitätsmedizin Berlin
NOT_YET_RECRUITING
Berlin
University Hospital for Children and Adolescents, Center for Pediatric Research, Medical Faculty, University of Leipzig
NOT_YET_RECRUITING
Leipzig
Division of Paediatric Endocrinology and Diabetes, Department of Paediatrics and Adolescent Medicine, Ulm University Medical Centre
RECRUITING
Ulm
Netherlands
University Medical Center Rotterdam, Erasmus MC-Sophia Children's Hospital
NOT_YET_RECRUITING
Rotterdam
Spain
Departments of Pediatrics & Pediatric Endocrinology, Hospital Infantil Universitario Niño Jesús, Universidad Autónoma de Madrid
NOT_YET_RECRUITING
Madrid
United Kingdom
Wellcome-MRC Institute of Metabolic Science and NIHR Cambridge Biomedical Research Centre
NOT_YET_RECRUITING
Cambridge
Contact Information
Primary
Martin Wabitsch, Prof. Dr.
martin.wabitsch@uniklinik-ulm.de
+4973150057401
Backup
Stefanie Zorn, Dr.
stefanie.zorn@uniklinik-ulm.de
+4973150057457
Time Frame
Start Date:2025-12-01
Estimated Completion Date:2028-12
Participants
Target number of participants:70
Treatments
Patients with biallelic variants in the LEPR, PCSK1, POMC, and MC4R gene
Patients with monoallelic variants in the LEPR gene
Patients with monoallelic variants in the PCSK1 gene
Patients with monoallelic variants in the POMC gene
Patients with monoallelic variants in the MC4R gene
Patients with monoallelic variants in the SH2B1 gene or with 16p11.2 deletions