Actively Recruiting
Efficacy of Semaglutide s.c. Once-weekly on Weight Loss and Management in Adolescents With Monogenic Obesity in Clinical Practice
Led by Prof. Dr. Martin Wabitsch · Updated on 2026-01-08
70
Participants Needed
7
Research Sites
156 weeks
Total Duration
On this page
Sponsors
P
Prof. Dr. Martin Wabitsch
Lead Sponsor
N
Novo Nordisk A/S
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Semaglutide s.c. Once-weekly on Weight Loss and Management in Adolescents With Monogenic Obesity in Clinical Practice
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 and adolescent assent, as age-appropriate.
- Age at time of signing informed consent: 12 to under 21 years.
- BMI at or above the 95th percentile based on sex- and age-specific CDC BMI growth charts.
- Body weight over 60 kg.
- Diagnosis of monogenic obesity confirmed by a certified laboratory using ACMG criteria as pathogenic, likely pathogenic, or variant of uncertain significance.
You will not qualify if you...
- Participation in any interventional clinical trials at the time of enrolment.
- Females of childbearing potential not using adequate contraceptive methods as required by local law or practice.
- Hypersensitivity to semaglutide or any listed excipients including disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid, sodium hydroxide, or water for injection.
- Patients treated with other products for weight management.
- Patients with type 1 diabetes.
- Patients with severe renal impairment.
- Patients with severe hepatic impairment.
- Patients with congestive heart failure New York Heart Association (NYHA) class IV.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Assistance Publique-Hôpitaux de Paris (AP-HP), Trousseau Hospital Paris, Pediatric Nutrition Department
Paris, France
Not Yet Recruiting
2
Institute for Experimental Pediatric Endocrinology, Charité Universitätsmedizin Berlin
Berlin, Germany, 13353
Not Yet Recruiting
3
University Hospital for Children and Adolescents, Center for Pediatric Research, Medical Faculty, University of Leipzig
Leipzig, Germany, 04103
Not Yet Recruiting
4
Division of Paediatric Endocrinology and Diabetes, Department of Paediatrics and Adolescent Medicine, Ulm University Medical Centre
Ulm, Germany, 89075
Actively Recruiting
5
University Medical Center Rotterdam, Erasmus MC-Sophia Children's Hospital
Rotterdam, Netherlands, 3015 GD
Not Yet Recruiting
6
Departments of Pediatrics & Pediatric Endocrinology, Hospital Infantil Universitario Niño Jesús, Universidad Autónoma de Madrid
Madrid, Spain, 28009
Not Yet Recruiting
7
Wellcome-MRC Institute of Metabolic Science and NIHR Cambridge Biomedical Research Centre
Cambridge, United Kingdom, CB2 0QQ
Not Yet Recruiting
Research Team
M
Martin Wabitsch, Prof. Dr.
CONTACT
S
Stefanie Zorn, Dr.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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