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)
Facility
City
Region
Status
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
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.