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Contrave for Weight Maintenance in Obesity (COR-WM Trial)
Phase 4
Waitlist Available
Led By Tony Chetty, MD
Research Sponsored by St. Joseph's Healthcare Hamilton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 to week 12, week 28 and week 52
Awards & highlights
COR-WM Trial Summary
This trial will help to determine if Contrave can help people who have lost weight to keep it off.
Who is the study for?
Adults over 18 with a BMI of 27 or higher who have lost at least 5% body weight through a behavior modification program can join. They must not have severe psychiatric disorders, seizure risks, substance abuse issues, recent heart attacks or strokes, certain organ impairments, or be pregnant/breastfeeding.Check my eligibility
What is being tested?
The trial tests if Contrave helps maintain and promote further weight loss after initial success from diet and exercise changes compared to a placebo. Participants will receive either Contrave or a dummy pill alongside usual care like dietary advice.See study design
What are the potential side effects?
Contrave may cause side effects such as nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth and sometimes seizures in those at risk. It's important for participants to report any discomfort they experience.
COR-WM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 0 to week 12, week 28 and week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 to week 12, week 28 and week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean Percentage Change in Body Weight
Percentage of participants who lost more than of equal to 5% of body weight
Secondary outcome measures
Average number of days participants took investigational product (Contrave or placebo)
Change in HbA1c
Change in blood pressure (both systolic and diastolic)
+18 moreOther outcome measures
Incidences of adverse events (AE)
Incidences of serious adverse events (SAE)
Number of participants discontinuing investigational product due to AE/SAEs
COR-WM Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Contrave 8mg/90mg Extended Release TabletExperimental Treatment1 Intervention
Group treated with Contrave Extended Release Tablets.
Group II: PlaceboPlacebo Group1 Intervention
Group given placebo
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Who is running the clinical trial?
St. Joseph's Healthcare HamiltonLead Sponsor
196 Previous Clinical Trials
25,455 Total Patients Enrolled
3 Trials studying Obesity
196 Patients Enrolled for Obesity
Bausch Health, Canada Inc.UNKNOWN
1 Previous Clinical Trials
18 Total Patients Enrolled
1 Trials studying Obesity
18 Patients Enrolled for Obesity
Tony Chetty, MDPrincipal InvestigatorThe Research Institute at St Joseph's Hamilton
1 Previous Clinical Trials
77 Total Patients Enrolled
1 Trials studying Obesity
77 Patients Enrolled for Obesity
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a diagnosis of major depressive disorder or other serious mental health conditions in the past two years.You have tried to harm yourself in the past or have shown signs of wanting to harm yourself recently.You are currently taking or planning to take other medications for weight loss, like Saxenda or Orlistat.You have a history of seizures or conditions that increase the risk of seizures, such as head trauma, brain tumors, or certain metabolic disorders.You regularly use strong pain medications like opioids or methadone, or are currently experiencing withdrawal symptoms from these medications.You drink too much alcohol or use drugs like cocaine or stimulants too often.You recently stopped drinking alcohol, taking medications like benzodiazepines or sedatives, or antiepileptic drugs suddenly.You are currently taking a medication called thioridazine, which can interact with the study drug bupropion and potentially cause heart rhythm problems.You had a heart attack or stroke less than 6 months ago.You cannot use other medications that contain bupropion (like Wellbutrin, Wellbutrin SR, Wellbutrin XL, and Zyban) because they can increase the risk of seizures.If you have been diagnosed with bulimia or anorexia nervosa, you cannot participate because it may increase the risk of seizures.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Contrave 8mg/90mg Extended Release Tablet
Awards:
This trial has 4 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Washington
Florida
North Dakota
Other
How old are they?
65+
18 - 65
What site did they apply to?
Humber River Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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