Naltrexone/Bupropion (Mysimba) to Optimize Weight Outcomes After Obesity Surgery

Launched by OSLO UNIVERSITY HOSPITAL · May 21, 2020

Keywords

ClinConnect Summary

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 po...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men and women aged 18-65 years who have undergone RYGB, mini-RYGB or sleeve gastrectomy 2 or more years previously and either
• • 1. Have a percent total weight loss from time of surgery of \<20% OR
• • 2. Have a regain of at least 5% or more of nadir weight (lowest weight at 12-18 months after surgery) AND
• • 3. Meet current clinical criteria for use of Mysimba (BMI ≥30 kg/m2 or BMI ≥27 kg/m2 with obesity-related comorbidity (diabetes type 2, controlled hypertension, dyslipidemia)
• Exclusion Criteria:
• • Serious illness or complications due to bariatric surgery according to the judgement of the investigators and clinical records
• • Use of any weight loss medications following bariatric surgery
• • Pregnancy or breastfeeding
• • Participation in other weight loss studies
• • Contraindication for use of Mysimba. These include but are not limited to epilepsy or history of seizure, uncontrolled hypertension (blood pressure ≥150/95 mmHg with or without medication), previous or current eating disorder, substance abuse, bipolar depression, serious liver or kidney disease, use of certain medications)