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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Nov 2027 to Jun 2028
    • Start date changed from estimate of Oct 15, 2024 to Jun 4, 2025
    • Study sites: 0 to 1
    • Study completion date: Dec 2027 to Aug 2028
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Laval University
86 trials monitored
See 1 trial at risk
Obesity
3,874 trials monitored
See 152 trials at risk
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.
Trial Details
NCT Number NCT06620562
Lead Sponsor Laval University
Collaborators: Bausch Health Americas, Inc.
Conditions
(from sponsor)		 Obesity; Drug, Obesity, Morbid
Related terms Obesity, Obesity, Morbid
Enrollment 108 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov