Weight Regain Post Bariatric Surgery Clinical Trial
Official title:
A Randomized, Double-Blind, Phase 4 Study to Evaluate the Efficacy of Naltrexone HCl/Bupropion HCl Extended Release Versus Placebo for Treatment of Weight Regain in Patients Post Bariatric Surgery
The purpose of this study is to determine the effect of naltrexone hydrochloride(HCL) and bupropion hydrochloride extended release combination (NB) compared with placebo on weight loss in obese participants post bariatric surgery.
The drug being tested in this study is called naltrexone hydrochloride/bupropion
hydrochloride (NB). NB is being tested to determine its effect on weight loss in obese
participants post bariatric surgery.
The study will enroll approximately 60 participants. Participants will be randomly assigned
to one of the two treatment groups—which will remain undisclosed to the participant and
study doctor during the study (unless there is an urgent medical need):
- Naltrexone HCl 32 mg/bupropion HCl 360 mg extended-release tablet
- Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has
no active ingredient
All participants will start on 1 tablet a day and will increase their dose by 1 tablet per
week for 4 weeks to reach the optimal dose.
This multi-center trial will be conducted in the United States. The overall time to
participate in this study is 59 weeks maximum. Participants will make multiple visits to the
clinic, plus a final visit 4 weeks after last dose of study drug for a follow-up assessment.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment