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

NCT04399395 | Withdrawn Phase 4

• 1 other identifier: 32772
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Body weight

  Body weight

  7 months

Study Arms (2)

Lifestyle and naltrexone/bupropion

ACTIVE COMPARATOR

Drug: Naltrexone/bupropion; Other: Lifestyle

Lifestyle

OTHER

Other: Lifestyle

Interventions

Naltrexone/bupropion DRUG

Approved drug for obesity treatment

Lifestyle and naltrexone/bupropion

Lifestyle OTHER

Lifestyle

Lifestyle; Lifestyle and naltrexone/bupropion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oslo University Hospital: lead
• Orexigen Therapeutics, Inc: collaborator

MeSH Terms

Conditions

Obesity

Interventions

Naltrexone; Bupropion

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Propiophenones; Ketones; Organic Chemicals

Study Officials

• Serena Tonstad, MD PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 22, 2020
• Study Start: November 1, 2020
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: March 1, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share