Actively Recruiting

Age: 18Years +
All Genders
NCT06380426

Real-life Evaluation of WEGOVY (Semaglutide) Treatment in Adults With Monogenic Obesity (ObGeSema)

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-08-07

175

Participants Needed

2

Research Sites

166 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Rare genetic forms of obesity, so called monogenic obesity are linked to alteration in energy balance involving hypothalamic pathways. More than 60 genes encoding for proteins located in the hypothalamic leptin/melanocortin pathway have been described in the French National Protocol for Diagnostic and Care (PNDS). The natural history of monogenic obesity is characterized by an early onset in childhood, with a major increase in weight in adolescence and young adulthood. The worsening of obesity exposes these patients to severe complications. Severe obesity and eating disorders have a major impact on the quality of life of the person but also of the family and caregivers. Clinical management is complex and requires comprehensive, specialized and multidisciplinary management. But the usual lifestyle approaches have so far shown disappointing results, similarly to bariatric surgery which leads to a more frequent weight regain in the situation of monogenic obesity, justifying new approaches. In this context, evaluating the response to treatment in the particular condition of monogenic obesity is crucial to propose therapeutic options as early as possible to limit weight evolution and its complications. GLP-1 (glucagon-like peptide 1) based innovative therapies have recently emerged as a promising option for treatment of obesity and its complications. This is the case for Semaglutide 2.4mg/week (WEGOVY®), developed by Novo Nordisk. However, there is a lack of data to confirm that semaglutide could be also effective in monogenic obesity. The hypothesis in this study is that treatment with Semaglutide 2.4mg/week (WEGOVY®) could be as effective in monogenic obesities as in common obesity.

CONDITIONS

Official Title

Real-life Evaluation of WEGOVY (Semaglutide) Treatment in Adults With Monogenic Obesity (ObGeSema)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older who have started or will soon start treatment with Semaglutide (WEGOVY4)
  • Genetic confirmation of monogenic obesity with a pathogenic or likely pathogenic variant in a leptin-melanocortin pathway gene as described in the French National Protocol for Diagnostic and Care (PNDS)
  • Patients who have been informed about the study and do not object to participation
  • Patients affiliated with a social security scheme or State Medical Assistance (AME)
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Centre de référence Syndrome de Prader-Willi et autres obésités avec troubles du comportement alimentaire (PRADORT). Service de Nutrition, GH Pitié-Salpêtrière, APHP

Paris, France, 75013

Not Yet Recruiting

2

CHU Pitié Salpêtrière - APHP

Paris, France, 75013

Actively Recruiting

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Research Team

C

Christine POITOU-BERNERT, MD,PhD

CONTACT

S

Sarra POCHON

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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