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

NCT06380426 | Recruiting

• 2 other identifiers: APHP230441IDRCB : 2023-A02003-42
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 2

Brief Summary

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

Monogenic Obesity

Keywords

Monogenic obesity; Semaglutide; WEGOVY

Outcome Measures

Primary Outcomes (1)

• Change in weight and Body Mass Index (BMI)

  Percentage of subjects with a change in weight and Body Mass Index (BMI).Weight will be measured at initiation and at 12 months of the Wegovy treatment

  From baseline (T0) to T12

Secondary Outcomes (14)

• Change in weight and Body Mass Index (BMI)

  From baseline (T0) to 6 and/or 24 and/or 36 and/or 48 and/or 60 months

• Reduction of body weight equal to or above 5%

  From baseline (T0) to 6 and/or 12 and/or 24 and/or 36 and/or 48 and/or 60 months

• Change in Hunger score

  From baseline (T0) to 12 and/or 24 and/or 36 and/or 48 and/or 60 months

• Change in eating behaviour measured by Food Craving questionnaire

  From baseline (T0) to 12 months

• Change in eating behaviour measured by the Binge Eating Scale (BES)

  From baseline (T0) to 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (≥18 years) with monogenic obesity due to a pathogenic variant already treated or with the physician's decision to initiate treatment with Semaglutide 2.4mg/week (WEGOVY®) in the standard care. Patients under legal protection and State Medical Assistance (AME) will be included.

You may qualify if:

• Adult Patients (≥18 years)having already initiated a treatment with SEMAGLUTIDE (WEGOVY®) or with a physician's decision to initiate treatment in the standard care in the near future. All patients having initiated a treatment will be proposed to participate, including those having already stopped the treatment at the time of study initiation.
• Confirmation of monogenic obesity, as practiced in clinical routine, by the presence of a pathogenic or likely pathogenic variant in a gene with leptin-melanocortin pathway described in PNDS (https://www.has-sante.fr/jcms/p\_3280217/fr/generique-obesites-de-causes-rares)
• Patients duly informed and not objecting to participate in the study
• Patients affiliated to a social security scheme or State Medical Assistance (AME).

You may not qualify if:

• Pregnant and breastfeeding women

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

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

Paris, 75013, France

NOT YET RECRUITING

CHU Pitié Salpêtrière - APHP

Paris, 75013, France

RECRUITING

Study Officials

• Christine POITOU-BERNERT, MD,PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Béatrice DUBERN, MD,PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Christine POITOU-BERNERT, MD,PhD

CONTACT

+33(0)142175771; christine.poitou-bernert@aphp.fr

Sarra POCHON

CONTACT

+33(0)142167574; sarra.pochon@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 23, 2024
• Study Start: September 19, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodological sound proposal.

Locations

FR (2)