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

Sponsor
Prof. Dr. Martin Wabitsch
Study ID
NCT07302802
Status
Recruiting
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Conditions

  • Monogenic Obesity

Eligibility Criteria

Sex
ALL
Age
12 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • 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).

Study Details

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.

Key Dates

Start date
Dec 1, 2025
Status verified
Jan 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
70 participants (estimated)

Arms

  • Arm: Patients with biallelic variants in the LEPR, PCSK1, POMC, and MC4R gene
  • Arm: Patients with monoallelic variants in the LEPR gene
  • Arm: Patients with monoallelic variants in the PCSK1 gene
  • Arm: Patients with monoallelic variants in the POMC gene
  • Arm: Patients with monoallelic variants in the MC4R gene
  • Arm: Patients with monoallelic variants in the SH2B1 gene or with 16p11.2 deletions

Primary Outcome Measure

Proportion of participants achieving ≥10% BMI reduction from baseline (week 0) to week 68. [ Time Frame: 68 weeks ]

Central Contacts