Efficacy of Semaglutide s.c. Once-weekly on Weight Loss and Management in Adolescents With Monogenic Obesity in Clinical Practice
Recruiting · NCT07302802 · Observational (researchers observe without assigning treatment) · Lead sponsor: Prof. Dr. Martin Wabitsch
View the official record on ClinicalTrials.gov →Interventions studied
Semaglutide (administered by PDS290 pen-injector)
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.
Who can take part
Age range
12 Years to 21 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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).
Exclusion criteria
- Participation in any interventional clinical trials at the time of enrolment.
- Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice)
- 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
- 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
Where it is running
7 locations listed.
- Institute for Experimental Pediatric Endocrinology, Charité Universitätsmedizin Berlin - Berlin, Germany
- Wellcome-MRC Institute of Metabolic Science and NIHR Cambridge Biomedical Research Centre - Cambridge, United Kingdom
- University Hospital for Children and Adolescents, Center for Pediatric Research, Medical Faculty, University of Leipzig - Leipzig, Germany
- Departments of Pediatrics & Pediatric Endocrinology, Hospital Infantil Universitario Niño Jesús, Universidad Autónoma de Madrid - Madrid, Spain
- Assistance Publique-Hôpitaux de Paris (AP-HP), Trousseau Hospital Paris, Pediatric Nutrition Department - Paris, France
- University Medical Center Rotterdam, Erasmus MC-Sophia Children's Hospital - Rotterdam, Netherlands
- Division of Paediatric Endocrinology and Diabetes, Department of Paediatrics and Adolescent Medicine, Ulm University Medical Centre - Ulm, Germany