Naltrexone/Bupropion (Mysimba) to Optimize Weight Outcomes After Obesity Surgery
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|ClinicalTrials.gov Identifier: NCT04399395|
Recruitment Status : Withdrawn (Covid-pandemic)
First Posted : May 22, 2020
Last Update Posted : March 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Drug: Naltrexone/bupropion Other: Lifestyle||Phase 4|
Study aim and endpoints The aim of this pilot study is to evaluate the effect of Mysimba in patients with suboptimal weight loss or weight regain after bariatric surgery. The primary endpoint is body weight.
Objective The study objective is to understand whether patients with suboptimal weight loss or weight regain 2 years or more following bariatric surgery achieve better weight loss with Mysimba and dietary counselling compared with a control group treated with dietary counselling alone.
This is a phase IV, open label randomized controlled study conducted over 7 months with a 3-month post-intervention follow-up. The study will be conducted in accordance with good clinical practice. Patients meeting eligibility criteria will be randomized into one of two groups: an intervention group treated with Mysimba and lifestyle and a control group treated with lifestyle. The intervention group will be prescribed Mysimba gradually titrated to the maximum tolerated dose (maximum dose is 32 mg/360 mg divided in 4 tablets) with 2 week intervals. Both groups will receive the same follow up including dietary counselling during the course of the study. Randomization will be done using a standard internet-based program where group assignment cannot be anticipated. The study is not blinded.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Treatment With Naltrexone/Buprpion (Mysimba) to Optimize Weight Outcomes After Bariatric Surgery|
|Actual Study Start Date :||November 1, 2020|
|Estimated Primary Completion Date :||September 30, 2022|
|Estimated Study Completion Date :||December 31, 2022|
|Active Comparator: Lifestyle and naltrexone/bupropion||
Approved drug for obesity treatment
- Body weight [ Time Frame: 7 months ]Body weight
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04399395
|Principal Investigator:||Serena Tonstad, MD PhD||Oslo University Hospital|