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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.
The primary objective of this prospective, non-interventional observational study is to evaluate the effect of once-weekly s.c. semaglutide 2.4 mg in routine clinical care as an adjunct to a calorie-reduced diet and increased physical activity on weight loss after 68 weeks of treatment in adolescents diagnosed with monogenic obesity. The secondary objectives of this prospective, non-interventional observation are to evaluate treatment compliance and to assess the influence of once-weekly s.c. semaglutide 2.4 mg in clinical practice on hunger score, body mass parameters, body composition, and depression score after 68 weeks of treatment in adolescents diagnosed with monogenic obesity. In addition, we will document the known parameters of safety and tolerability to determine safety and tolerability in clinical practice. The exploratory objective of this prospective, non-interventional observation is to assess user satisfaction by measuring change in subjective hunger score, quality of life, and perceptions and attitudes regarding treatment with semaglutide in adolescents diagnosed with monogenic obesity treated in routine clinical practice with once-weekly s.c. semaglutide 2.4 mg after 68 weeks of treatment.
Age
12 - 21 years
Sex
ALL
Healthy Volunteers
No
Assistance Publique-Hôpitaux de Paris (AP-HP), Trousseau Hospital Paris, Pediatric Nutrition Department
Paris, France
Institute for Experimental Pediatric Endocrinology, Charité Universitätsmedizin Berlin
Berlin, Germany
University Hospital for Children and Adolescents, Center for Pediatric Research, Medical Faculty, University of Leipzig
Leipzig, Germany
Division of Paediatric Endocrinology and Diabetes, Department of Paediatrics and Adolescent Medicine, Ulm University Medical Centre
Ulm, Germany
University Medical Center Rotterdam, Erasmus MC-Sophia Children's Hospital
Rotterdam, Netherlands
Departments of Pediatrics & Pediatric Endocrinology, Hospital Infantil Universitario Niño Jesús, Universidad Autónoma de Madrid
Madrid, Spain
Wellcome-MRC Institute of Metabolic Science and NIHR Cambridge Biomedical Research Centre
Cambridge, United Kingdom
Start Date
December 1, 2025
Primary Completion Date
June 1, 2028
Completion Date
December 1, 2028
Last Updated
January 8, 2026
70
ESTIMATED participants
Semaglutide (administered by PDS290 pen-injector)
DRUG
Lead Sponsor
Prof. Dr. Martin Wabitsch
Collaborators
Data Source & Attribution
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