Status:
WITHDRAWN
Naltrexone/Bupropion (Mysimba) to Optimize Weight Outcomes After Obesity Surgery
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
Orexigen Therapeutics, Inc
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 red...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Men and women aged 18-65 years who have undergone RYGB, mini-RYGB or sleeve gastrectomy 2 or more years previously and either
- Have a percent total weight loss from time of surgery of \<20% OR
- Have a regain of at least 5% or more of nadir weight (lowest weight at 12-18 months after surgery) AND
- 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
- 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)
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04399395
Start Date
November 1 2020
End Date
December 31 2022
Last Update
March 1 2021
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