Clinical trial

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

Recruiting now · Not applicable · 5 countries · Registry ID NCT07302802

Recruiting nowNot applicableObservational

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age12 Years to 21 Years
SexAll
Healthy volunteersNot accepted
ConditionMonogenic Obesity

Full registry criteria

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

Treatments and study arms

Semaglutide (administered by PDS290 pen-injector)

Drug

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).

Primary outcomes

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.

Study locations

7 locations were listed when this page was built. The first 40 are shown.

Assistance Publique-Hôpitaux de Paris (AP-HP), Trousseau Hospital Paris, Pediatric Nutrition Department🇫🇷 Paris, France
Béatrice Dubern, Prof. Dr.Contact
Institute for Experimental Pediatric Endocrinology, Charité Universitätsmedizin Berlin🇩🇪 Berlin, Germany
Peter Kühnen, Prof. Dr.Contact
University Hospital for Children and Adolescents, Center for Pediatric Research, Medical Faculty, University of Leipzig🇩🇪 Leipzig, Germany
Antje Körner, Prof. Dr.Contact
Division of Paediatric Endocrinology and Diabetes, Department of Paediatrics and Adolescent Medicine, Ulm University Medical Centre🇩🇪 Ulm, Germany
Martin Wabitsch, Prof. Dr.Contact
Stefanie Zorn, Dr.Contact
University Medical Center Rotterdam, Erasmus MC-Sophia Children's Hospital🇳🇱 Rotterdam, Netherlands
Erica van den Akker, Prof. Dr.Contact
Departments of Pediatrics & Pediatric Endocrinology, Hospital Infantil Universitario Niño Jesús, Universidad Autónoma de Madrid🇪🇸 Madrid, Spain
Jesús Argente, Prof. Dr.Contact
Wellcome-MRC Institute of Metabolic Science and NIHR Cambridge Biomedical Research Centre🇬🇧 Cambridge, United Kingdom
Sadaf Farooqi, Prof. Dr.Contact