Evaluating WEGOVY treatment for adults with genetic obesity
A Multicenter Pharmacoepidemiological Cohort on Real Life Use of WEGOVY (Semaglutide) in Obese Patients With Monogenic Obesity
This study is testing how well WEGOVY helps adults with a rare genetic obesity condition manage their weight and related health issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 175 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT06380426 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on adults diagnosed with monogenic obesity, a rare genetic condition affecting energy balance. Participants who have started treatment with Semaglutide (WEGOVY) will be monitored to evaluate the effectiveness of this therapy in managing their condition. The study aims to gather real-life data on the treatment's impact on weight management and associated complications, addressing the need for effective therapeutic options in this challenging patient population. By analyzing the outcomes, the study seeks to inform future clinical practices for managing monogenic obesity.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with monogenic obesity and are currently receiving or about to receive treatment with Semaglutide.
Not a fit: Patients who are pregnant or breastfeeding will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into effective treatment options for patients with monogenic obesity, potentially improving their quality of life.
How similar studies have performed: While there is limited data specifically on Semaglutide for monogenic obesity, GLP-1 based therapies have shown promise in treating obesity in general, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * Pregnant and breastfeeding women
Where this trial is running
Paris and 1 other locations
- 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 (Not_yet_recruiting)
- CHU Pitié Salpêtrière - APHP — Paris, France (Recruiting)
Study contacts
- Principal investigator: Christine POITOU-BERNERT, MD,PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Christine POITOU-BERNERT, MD,PhD
- Email: christine.poitou-bernert@aphp.fr
- Phone: +33(0)142175771
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.