Maridebart Cafraglutide for Obesity
(MARITIME-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether maridebart cafraglutide can help people lose weight more effectively than a placebo (a substance with no active medication). It tests different doses to determine which is most effective. Suitable participants are adults with a body mass index (BMI) of 27 or higher, who have not succeeded with diet and exercise, and have type 2 diabetes (a condition where the body cannot use insulin properly). As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for weight loss.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that maridebart cafraglutide has been tested in people with obesity and type 2 diabetes. In these studies, participants lost a significant amount of weight. For instance, some trials reported an average weight loss of up to 20% in those without type 2 diabetes.
The studies also examined how well participants tolerated the treatment. Although detailed safety information for each dose is not provided here, the treatment's progression to a late-stage trial suggests it has been deemed safe enough to reach this point.
Earlier trials likely found it generally well-tolerated with manageable side effects. If the FDA approves the treatment for another condition, it further supports its safety in humans. However, joining a trial requires discussing potential risks with the study team to determine if it's suitable.12345Why do researchers think this study treatment might be promising for obesity?
Unlike the standard treatments for obesity, which often include lifestyle changes and medications like orlistat, liraglutide, or phentermine, Maridebart Cafraglutide offers a unique approach. Researchers are excited about this treatment because it uses a new active ingredient, potentially providing a different mechanism of action that targets obesity more effectively. Additionally, Maridebart Cafraglutide is administered subcutaneously, which might improve patient compliance compared to oral medications. With high, medium, and low dose options being explored, this treatment could offer tailored solutions to meet individual patient needs.
What evidence suggests that maridebart cafraglutide could be an effective treatment for obesity?
Research has shown that maridebart cafraglutide can aid weight loss in people with obesity. In earlier studies, participants taking this treatment lost up to 20% of their body weight. Those with type 2 diabetes experienced nearly 17% weight loss. Another study reported an average weight loss of 12.3% for individuals with both obesity and diabetes. These findings suggest that maridebart cafraglutide could be highly effective for weight loss. Participants in this trial will receive a high, medium, or low dose of maridebart cafraglutide, or a placebo, to further evaluate its effectiveness.12367
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
Adults with Type 2 Diabetes Mellitus (T2DM) who are overweight or have obesity can join this trial. They should be at least 18 years old, have a BMI of 27 kg/m^2 or higher, and have tried losing weight unsuccessfully through diet and exercise.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive maridebart cafraglutide or placebo subcutaneously for 72 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Maridebart Cafraglutide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London