NCT06620562RecruitingPhase 4
Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet
Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet - A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 8 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- First submitted
- 6 Aug 2024
- Start date
- 4 Jun 2025
- Primary completion date
- Jun 2028
- Lead sponsor
- Laval University
- Diseases
- Obesity
- NCT number
- NCT06620562
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 108
- From 4 Jun 2025 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Revisional or reoperative surgery
- Simultaneous use of other weight loss medication
- Concomitant administration of monoamine oxidase inhibitors.
- Concomitant use of CYP2B6 inhibitors (ticlopidine or clopidogrel)
- Concomitant administration of the antipsychotic thioridazine
- Current or prior diagnosis of bulimia or anorexia nervosa
Other illness
- Uncontrolled hypertension
- End-stage liver or kidney disease
- Seizure disorder or a history of seizures
- Cardiac pacemaker
Other
- Pregnancy or planned pregnancy in the next 24 months
- Chronic opioid use or opiate agonist (e.g., methadone) or partial agonists (e.g., buprenorphine) use, or acute opiate withdrawal.
- Use of other bupropion-containing products
Who the study is looking for
- MBI above 30 kg/m2 with obesity-related comorbidity or above 35 kg/m2 without associated comorbidities.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Criucpq-Ul Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.