RecruitingNot Applicable

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

France, Germany, Netherlands70 participantsStarted 2025-12-01

Plain-language 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.

Who can participate

Age range12 Years – 21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
✕. The safety and efficacy of Wegovy have not been investigated in patients:

What they're measuring

Proportion of participants achieving ≥10% BMI reduction from baseline (week 0) to week 68.

Timeframe: 68 weeks

Trial details

NCT IDNCT07302802

SponsorProf. Dr. Martin Wabitsch

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-06

Contact for this trial

Martin Wabitsch, Prof. Dr.

+4973150057401 martin.wabitsch@uniklinik-ulm.de

View on ClinicalTrials.gov More Monogenic Obesity trials