Evaluating Contrave for Weight Maintenance in Adults With BMI >= 27 Kg/m2, After 6 Month Behaviour Modification Program.

NCT04589130 | Unknown Phase 4

• 1 other identifier: COR Weight Maintenance Study
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 3

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. Presently we do not have any evidence for the use of Contrave for weight maintenance. The purpose of this study is to demonstrate that in participants who have ≥ 5% weight loss following the completion of a behaviour modification program with meal replacements, Contrave combined with usual care (dietary and behaviour counselling) will significantly improve maintenance of weight loss and promote further weight loss, compared to placebo with usual care.

Conditions

Obesity

Keywords

weight loss maintenance

Outcome Measures

Primary Outcomes (3)

• Mean Percentage Change in Body Weight

  To determine the weight loss maintenance and any further weight loss effect of Contrave with usual care compared to placebo with usual care, in a post behaviour modification program population.

  Week 0 to Week 28

• Percentage of participants who maintained their weight

  To determine the weight loss maintenance effect of Contrave with usual care compared to placebo with usual care, in post behaviour modification program population (Participants who had a weight regain less than or equal to 3% of weight from Week 0 - 28 will be regarded as maintainers).

  Week 0 to Week 28

• Percentage of participants who lost more than of equal to 5% of body weight

  To determine any further weight loss effect of Contrave with usual care compared to placebo with usual care, in a post behaviour modification program population.

  Week 0 to Week 28

Secondary Outcomes (21)

• Mean Percentage Change in Body Weight from baseline to week 52

  Week 0 to Week 52

• Percentage of participants who maintained their weight

  Week 0 to Week 52

• Percentage of participants who lost more than or equal to 5% of body weight

  Week 0 to Week 52

• Percentage of participants who lost more than or equal to 10% of body weight

  Week 0 to Week 28 and Week 52

• Percentage of participants with weight regain (≥ 5% from baseline)

  Week 0 to Week 28 and Week 52

Other Outcomes (3)

• Incidences of adverse events (AE)

  Week 0 to Week 52

• Incidences of serious adverse events (SAE)

  Week 0 to Week 52

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

  Week 0 to Week 52

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). Participants randomized to the control arm for the first 6 months will crossover and be administered 4 Contrave tablets a day during the second 6 months (2 tablets taken twice a day). All participants will be in the treatment group (Contrave) during the second 6 month phase of the study.

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 (2 tablets, taken twice a day) during the first 6 months of the study. These participants will crossover to treatment with Contrave for the second 6 months of the study.

Also known as: Inactive

Placebo

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years of age
• Body Mass Index (BMI) of ≥ 27 Kg/m2 and the presence of at least one weight related co-morbidity
• Completed 6 month BCoE behaviour modification program with meal replacements and achieved ≥ 5% weight loss since start of program
• Able and willing to provide signed informed consent

You may not qualify if:

• Previous surgical treatment for obesity (excluding liposuction if performed more than one year before trial entry)
• 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
• Lifetime history of a suicide attempt or history of any suicidal behavior within the past month before entry into the trial
• 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
• Simultaneous or planned use of other weight loss medication (e.g. Saxenda / Orlistat)
• Uncontrolled hypertension, severe hepatic impairment, end-stage renal 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)
• 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
• A 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 (3)

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

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

• Tony Chetty, MD

  The Research Institute at St Joseph's Hamilton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking during first 6 month phase (treatment or placebo control). All participants receive treatment (Contrave) during second 6 months.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Pathology and Molecular Medicine

Model Details: Parallel - 2 arms during first 6 month phase (treatment and placebo control) Crossover - placebo control group crosses over to treatment arm during second 6 months of the study

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 19, 2020
• Study Start: February 1, 2021
• Primary Completion: December 31, 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 (3)