What side effects are associated with this type of intervention?

Common treatments for obesity, such as Contrave (naltrexone HCl and bupropion HCl), have several known side effects. Naltrexone can cause nausea, headache, dizziness, and fatigue, while bupropion may lead to insomnia, dry mouth, headache, and increased blood pressure. Other similar medications include lorcaserin, which can cause headache, dizziness, fatigue, nausea, dry mouth, and constipation, and liraglutide, which may result in nausea, vomiting, diarrhea, constipation, and low blood sugar. These side effects should be carefully considered when selecting an obesity treatment.

What prior FDA approvals exist?

Contrave, a combination of naltrexone HCl and bupropion HCl, is approved by the FDA for chronic weight management in obese or overweight adults with at least one weight-related condition. Naltrexone is an opioid antagonist, and bupropion is a norepinephrine-dopamine reuptake inhibitor. Other FDA-approved drugs for obesity treatment include orlistat, which reduces fat absorption, and liraglutide, a GLP-1 receptor agonist that regulates appetite. Phentermine-topiramate is another combination therapy that combines an appetite suppressant with an anticonvulsant. These treatments, like Contrave, are typically used alongside lifestyle modifications such as a low-calorie diet and increased physical activity.

What other types of research exist?

Promising novel alternatives to Contrave for obesity treatment include: <ol> <li>Liraglutide: A GLP-1 receptor agonist that has shown efficacy in weight management.</li> <li></li> </ol> Lorcaserin: A serotonin 2C receptor agonist that helps reduce appetite. 3. Topiramate: An anticonvulsant that has been used off-label for weight loss. 4. Metformin: Commonly used for diabetes, it has shown weight loss benefits in some patients. 5. Olanzapine/Samidorphan: A combination that may help manage weight gain associated with antipsychotic use.

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Contrave for Post-Bariatric Surgery Weight Management (COR-WR Trial)

Phase 4

Waitlist Available

Led By Aristithes G Doumouras, 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 baseline to 12 months

Awards & highlights

Approved for 10 Other Conditions

Drug Has Already Been Approved

Pivotal Trial

All Individual Drugs Already Approved

Summary

This trial is testing Contrave, a weight management pill, in adults who had bariatric surgery but are struggling with weight loss or regaining weight. The pill helps reduce hunger and increase feelings of fullness. Contrave, a combination of bupropion and naltrexone, was approved for chronic weight management in obese adults and has shown effectiveness in reducing food intake. The study will compare the effects of Contrave combined with usual care to usual care alone.

Who is the study for?

This trial is for adults who've had bariatric surgery but didn't lose enough weight or regained a lot after the surgery. They must have a BMI of ≥30 or ≥27 with related health issues like diabetes. Participants should not have eating disorders, severe organ impairments, recent heart attacks or strokes, be pregnant, use certain medications including MAOIs and opioids, or have uncontrolled mental health conditions.

What is being tested?

The study tests if Contrave (a weight loss medication) helps people who've had bariatric surgery but are struggling with weight loss. It compares the effectiveness of Contrave plus diet and behavior counseling to a placebo (no active drug) combined with the same counseling.

What are the potential side effects?

Contrave can cause side effects such as seizures in those predisposed to them; it may also lead to headaches, digestive upset, dry mouth, insomnia, increased blood pressure and heart rate. People might experience mood changes like depression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in absolute weight (Kg)

Proportion of participants achieving 5 percent total weight loss

Secondary study objectives

Average number of days participants took investigational product (Contrave or placebo)

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

Change in blood pressure

+15 more

Other study objectives

Incidences of adverse events (AE)

Incidences of serious adverse events (SAE)

Number of participants discontinuing investigational product due to AE/SAEs

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity, such as the combination of naltrexone and bupropion (found in Contrave), work by targeting the brain's reward and appetite regulation systems. Naltrexone is an opioid antagonist that blocks opioid receptors, reducing the pleasure associated with eating. Bupropion is a norepinephrine-dopamine reuptake inhibitor that stimulates the hypothalamus to decrease appetite and increase energy expenditure. Together, these drugs help reduce food cravings and promote weight loss. Understanding these mechanisms is crucial for obesity patients as it highlights the importance of addressing both the psychological and physiological aspects of weight management, leading to more effective and sustainable treatment outcomes.

Understanding the Mechanism of Action and Clinical Implications of Anti-Obesity Drugs Recently Approved in Korea.