Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLaval University
About this trial
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.
Eligibility criteria
Qualifiers
MBI above 30 kg/m2 with obesity-related comorbidity or above 35 kg/m2 without associated comorbidities.
Disqualifiers
Revisional or reoperative surgery
Pregnancy or planned pregnancy in the next 24 months
Simultaneous use of other weight loss medication
Uncontrolled hypertension
Trial design
Treatments tested in this trial
- Naltrexone/Bupropion
- Placebo
Treatment groups
108 Participants
are divided into 2 treatment groupsSponsors and collaborators
Laval University
Lead sponsor
Bausch Health Americas, Inc.
Collaborator
Source ClinicalTrials.gov