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

• Status: Withdrawn
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Limited/poor weight loss and weight regain are concerns following bariatric surgery, and weight regain may increase the risk for relapse of comorbidities related to obesity. Medications for weight reduction may assist further weight loss, and support weight maintenance, with positive effects on comorbidities. This pilot study will examine the effect of naltrexone/bupropion and lifestyle advice versus lifestyle advice alone for 7 months in patients with a suboptimal weight trajectory (either little weight loss or weight regain) 2 years or later following bariatric surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Collaborator: Orexigen Therapeutics, Inc
• Treatments: Bupropion; Naltrexone

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)