Who is sponsoring NCT06620562?

NCT06620562 is sponsored by Laval University.

What condition does NCT06620562 study?

NCT06620562 studies Obesity; Drug, Obesity, Morbid.

What drugs are being tested in NCT06620562?

Interventions: Naltrexone/Bupropion, Placebo.

What is the status of NCT06620562?

NCT06620562 is currently RECRUITING.

Last reviewed 2025-08-04 · How we verify

Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet - A Randomized Controlled Trial

NCT06620562 Phase 4 RECRUITING

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.

Details

Lead sponsor	Laval University
Phase	Phase 4
Status	RECRUITING
Enrolment	108
Start date	2025-06-04
Completion	2028-08

Conditions

Obesity; Drug
Obesity, Morbid

Interventions

Naltrexone/Bupropion
Placebo

Primary outcomes

Weight loss — baseline to 24 months
% Excess weight loss
Percentage of participant with an Excess Weight Loss above 50% — Baseline to 24 months

Countries

Canada