A Trial Evaluating the Effectiveness of Contrave in Patients Who Have Weight Recidivism Following Bariatric Surgery

NCT04587843 | Unknown Phase 4

• 1 other identifier: COR Weight Regain Study
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief Summary

Contrave (naltrexone HCl and bupropion HCl) extended-release tablet is an approved drug and indicated to be used with a low calorie diet and increased physical activity for chronic weight management in obese adults (BMI 30 Kg/m2 or greater) or overweight adults (BMI 27 Kg/m2 or greater) with at least one weight related condition such as hypertension or diabetes. It is unknown how many or which medical treatments for weight loss, such as Contrave work in the subjects who have had bariatric surgery. The purpose of this study is to explore the effectiveness of Contrave combined with usual care (dietary and behaviour counselling) compared to placebo with usual care, in patients who have inadequate weight loss or significant weight regain following bariatric surgery.

Conditions

Obesity

Keywords

weight recidivism; weight regain; inadequate weight loss

Outcome Measures

Primary Outcomes (2)

• Change in absolute weight (Kg)

  To determine the weight loss effect of Contrave with usual care compared to placebo with usual care, in a post-bariatric surgery population with weight loss failure.

  Baseline to 12 months

• Proportion of participants achieving 5 percent total weight loss

  To determine the weight loss effect of Contrave with usual care compared to placebo with usual care, in a post-bariatric surgery population with weight loss failure compared to a placebo with usual care.

  Baseline to 12 months

Secondary Outcomes (18)

• Change in Body Mass Index (BMI) (Kg/m2)

  Baseline to 12 months

• Percentage total body weight loss (percentage TBWL)

  Baseline to 12 months

• Proportion of participants losing at least 10 percent baseline weight at 12 months

  Baseline to 12 months

• Percent change in HbA1c level

  Baseline to 12 months

• Change in blood pressure

  Baseline to 12 months

Other Outcomes (3)

• Incidences of adverse events (AE)

  Baseline to 12 months

• Incidences of serious adverse events (SAE)

  Baseline to 12 months

• Number of participants discontinuing investigational product due to AE/SAEs

  Baseline to 12 months

Study Arms (2)

Contrave 8mg/90mg Extended Release Tablet

EXPERIMENTAL

Group treated with Contrave Extended Release Tablets

Drug: Contrave 8Mg-90Mg Extended-Release Tablet

Placebo

PLACEBO COMPARATOR

Group given placebo

Drug: Placebo

Interventions

Contrave 8Mg-90Mg Extended-Release Tablet DRUG

Each Contrave Extended Release Tablet contains 8Mg of naltrexone HCl and 90Mg of bupropion HCl and will be administered orally. Total daily dose is 32Mg / 360Mg. Participants randomized to the treatment arm will be administered 4 Contrave tablets a day for 1 year (2 tablets taken twice a day).

Also known as: naltrexone HCl/bupropion HCl

Contrave 8mg/90mg Extended Release Tablet

Placebo DRUG

Placebo tablets will be administered orally. Participants randomized to the control arm will be administered 4 placebo tablets a day for 1 year (2 tablets, taken twice a day).

Also known as: Inactive

Placebo

Eligibility Criteria

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

You may qualify if:

• \>=18 years of age
• prior primary roux en-y gastric bypass (RYGB) or sleeve gastrectomy (SG) at a surgical Center of Excellence within the Ontario Bariatric Network (OBN)
• inadequate weight loss or significant weight regain based on the OBN criteria13, defined as one of the following:
• \< 10% total body weight (TBW) loss at 6 months or;
• \< 20% TBW loss at 12 months or;
• Weight regain of \> 25% of weight loss.
• body Mass Index (BMI) of ≥ 30 Kg/m2 or ≥ 27 Kg/m2 and the presence of at least one weight related co-morbidity
• able and willing to provide signed informed consent

You may not qualify if:

• pregnancy, planned pregnancy in the next 18 months and or breastfeeding
• does not agree to use highly effective method of birth control if a woman of child bearing potential, for the duration of the study
• revisional bariatric procedure or duodenal switch
• simultaneous or planned use of other weight loss medication (e.g. Saxenda / Orlistat) or meal replacement products (e.g. Optifast)
• uncontrolled hypertension, severe hepatic impairment, end-stage renal disease, end stage cardiac disease
• myocardial infarction or stroke within 6 months prior to consent
• renal impairment defined as eGFR \< 60
• seizure disorder or a history of seizures or following conditions that may predispose subjects to risk of seizure: history of head trauma, arteriovenous malformation, central nervous system tumor or infection, or a metabolic disorder that in opinion of the investigator may contraindicate treatment with Contrave and increase risk of seizure (e.g. hypoglycemia, hyponatremia)
• lifetime history of a suicide attempt or history of any suicidal behavior within the past month before entry into the trial
• history of major depressive disorder or a PHQ-9 (Patient Health Questionnaire-9) score of more than 15 within the last 2 years or history of other severe psychiatric disorders
• use of other bupropion-containing products (including, but not limited to, Wellbutrin, Wellbutrin SR, Wellbutrin XL, and Zyban), because the incidence of seizure is dose dependent
• current or prior diagnosis of bulimia or anorexia nervosa, because of a higher incidence of seizures
• chronic opioid or opiate agonist (eg, methadone) or partial agonists (eg, buprenorphine) use, or acute opiate withdrawal
• excessive use of alcohol or sedatives, addiction to cocaine or stimulants (street drugs), or withdrawal from sedatives
• patients undergoing an abrupt discontinuation of alcohol, benzodiazepines or other sedatives and antiepileptic drugs

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• Bausch Health, Canada Inc.: collaborator

Study Sites (4)

Guelph General Hospital

Guelph, Ontario, N1E 4J4, Canada

Location

St Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 3K7, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

Humber River Hospital

North York, Ontario, M3M 0B2, Canada

Location

MeSH Terms

Conditions

Obesity

Interventions

bupropion hydrochloride, naltrexone hydrochoride drug combination

Condition Hierarchy (Ancestors)

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

Study Officials

• Aristithes G Doumouras, MD

  St Joseph's Healthcare Hamilton / McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Pathology and Molecular Medicine

Model Details: Parallel, randomized, double blind, placebo controlled

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 14, 2020
• Study Start: April 1, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 31, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)