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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04399395
Recruitment Status : Withdrawn (Covid-pandemic)
First Posted : May 22, 2020
Last Update Posted : March 1, 2021
Sponsor:
Collaborator:
Orexigen Therapeutics, Inc
Information provided by (Responsible Party):
Serena Tonstad, Oslo University Hospital

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 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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Naltrexone/bupropion Other: Lifestyle Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Active Comparator: Lifestyle and naltrexone/bupropion Drug: Naltrexone/bupropion
Approved drug for obesity treatment

Other: Lifestyle
Lifestyle

Lifestyle Other: Lifestyle
Lifestyle




Primary Outcome Measures :
  1. Body weight [ Time Frame: 7 months ]
    Body weight



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Sponsors and Collaborators
Oslo University Hospital
Orexigen Therapeutics, Inc
Investigators
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Principal Investigator: Serena Tonstad, MD PhD Oslo University Hospital
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Responsible Party: Serena Tonstad, Consultant, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04399395    
Other Study ID Numbers: 32772
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Naltrexone
Bupropion
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors