- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04399395
Naltrexone/Bupropion (Mysimba) to Optimize Weight Outcomes After Obesity Surgery
Treatment With Naltrexone/Buprpion (Mysimba) to Optimize Weight Outcomes After Bariatric Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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 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
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- 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 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Lifestyle and naltrexone/bupropion
|
Approved drug for obesity treatment
Lifestyle
|
Other: Lifestyle
|
Lifestyle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body weight
Time Frame: 7 months
|
Body weight
|
7 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Serena Tonstad, MD PhD, Oslo University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Obesity
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Sensory System Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Narcotic Antagonists
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Alcohol Deterrents
- Dopamine Uptake Inhibitors
- Naltrexone
- Bupropion
Other Study ID Numbers
- 32772
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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