Clinical Trial

Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet

Recruiting Phase 4
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to assess the impact of combination therapy with Naltrexone-Bupropion (NB) in the post-operative period of sleeve gastrectomy (SG). on a) weight loss, b) resolution of comorbidities and c) eating behaviors. Researchers will compare SG-NB group with SG-placebo group to see if they experience significantly higher excess weight loss (EWL) at 12 and 24 months and if there is a significantly higher percentage of patients with an EWL above 50% in the SG-NB group versus in the SG-placebo group. Participants will be randomized 1:1 to SG in combination with NB versus SG with placebo. Patients will be started one month after surgery on a progressive dose of Naltrexone/Bupropion extended-release or placebo. Duration of therapy will be 24 months.Both groups will benefit from behavioral and nutritional support.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-09-26.
Status change: Not Yet Recruiting → Recruiting 2025-08-04
Trial Details
NCT Number NCT06620562
Lead Sponsor Laval University
Collaborators: Bausch Health Americas, Inc.
Conditions Obesity; Drug, Obesity, Morbid
Enrollment 108 participants
Start Date 2025-06-04
Primary Completion 2028-06 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2025-08-08