drugset / Trial / NCT04587843

A Trial Evaluating the Effectiveness of Contrave in Patients Who Have Weight Recidivism Following Bariatric Surgery

NCT04587843

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Contrave (naltrexone HCl and bupropion HCl) extended-release tablet is an approved drug and indicated to be used with a low calorie diet and increased physical activity for chronic weight management in obese adults (BMI 30 Kg/m2 or greater) or overweight adults (BMI 27 Kg/m2 or greater) with at least one weight related condition such as hypertension or diabetes. It is unknown how many or which medical treatments for weight loss, such as Contrave work in the subjects who have had bariatric surgery. The purpose of this study is to explore the effectiveness of Contrave combined with usual care (dietary and behaviour counselling) compared to placebo with usual care, in patients who have inadequate weight loss or significant weight regain following bariatric surgery.

Timeline

Start
2021-04-01
Primary completion
2023-12-30
Completion
2023-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupropion Small molecule 360 mg Oral
Subject Naltrexone Small molecule 32 mg Oral

Indications