What side effects are associated with this type of intervention?

Common treatments for obesity, such as naltrexone/bupropion (Contrave), liraglutide, orlistat, and phentermine/topiramate, have various side effects. Naltrexone/bupropion can cause nausea, constipation, headache, vomiting, dizziness, insomnia, and dry mouth. Liraglutide may lead to gastrointestinal issues like nausea, vomiting, and diarrhea. Orlistat is known for causing gastrointestinal side effects such as oily stools, flatulence, and frequent bowel movements. Phentermine/topiramate can result in increased heart rate, insomnia, dry mouth, dizziness, and constipation. Patients should discuss these potential side effects with their healthcare provider to determine the most suitable treatment option.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of obesity, including Contrave, which combines naltrexone HCl (an opioid antagonist) and bupropion HCl (a norepinephrine-dopamine reuptake inhibitor). Other FDA-approved drugs for obesity management include orlistat, which works by inhibiting fat absorption, and liraglutide, a GLP-1 receptor agonist that helps regulate appetite. Additionally, phentermine-topiramate extended-release is another combination drug that has been approved for weight management. These treatments are typically used in conjunction with 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>Semaglutide: A GLP-1 receptor agonist that has shown significant weight loss in clinical trials.</li> <li></li> </ol> Tirzepatide: A dual GIP and GLP-1 receptor agonist that has demonstrated superior weight loss compared to other treatments. 3. Setmelanotide: A melanocortin 4 receptor (MC4R) agonist, particularly effective in patients with specific genetic obesity disorders. These medications represent the latest advancements in pharmacotherapy for obesity and may offer effective alternatives to Contrave.

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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

Pivotal Trial

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Drug Has Already Been Approved

Summary

This trial tests if Contrave, a weight-loss pill, helps maintain and further weight loss in obese or overweight adults who have already lost some weight through a diet program. The pill works by reducing hunger and increasing satisfaction with less food. Contrave is a combination of naltrexone and bupropion, developed by Orexigen Therapeutics Inc, and has shown moderate weight loss in previous studies.

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.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 to week 12, week 28 and week 52 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Mean Percentage Change in Body Weight

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

Secondary study objectives

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

Change in HbA1c

Change in blood pressure (both systolic and diastolic)

+18 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

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.

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.

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

The most common treatments for obesity often target the brain's regulatory mechanisms for hunger and satiety. Contrave, which combines Naltrexone HCl and Bupropion HCl, exemplifies this approach. Naltrexone is an opioid antagonist that reduces cravings and the pleasure associated with eating, while Bupropion is a norepinephrine-dopamine reuptake inhibitor that helps control appetite and increase energy expenditure. These mechanisms are crucial for obesity patients as they address both the psychological and physiological aspects of eating behavior, making it easier to adhere to a low-calorie diet and maintain weight loss.

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