Maridebart Cafraglutide for Obesity
(MARITIME-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if maridebart cafraglutide aids weight loss more effectively than a placebo (a fake treatment). Researchers will test different doses of the drug to identify the most effective one for reducing body weight. Suitable participants have a BMI over 30 or a BMI between 27 and 30 with conditions such as high blood pressure or sleep apnea and have unsuccessfully tried to lose weight through diet and exercise. As a Phase 3 trial, this is the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking weight-loss treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether 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 was safe in earlier studies. One study found no unexpected safety issues, indicating it was generally well-tolerated by participants. Another study reported that the treatment's side effects were manageable.
These findings provide some confidence about the drug's safety. However, as this is a Phase 3 trial, maridebart cafraglutide is still being tested for safety and effectiveness in a larger group. More data is being collected to confirm these earlier results. For specific concerns or questions, discussing them with a doctor is advisable.12345Why are researchers excited about this trial's treatment for obesity?
Researchers are excited about Maridebart Cafraglutide for obesity because it offers a novel approach compared to current treatments like lifestyle changes, medications such as orlistat, or GLP-1 receptor agonists like semaglutide. Unlike these options, Maridebart Cafraglutide is a new drug that might work more effectively by impacting specific pathways in the body responsible for weight regulation. It is administered through a subcutaneous injection, which can help ensure consistent dosing. The study investigates different doses, including high, medium, and low, to find the most effective and safest option, potentially offering a tailored approach to treating obesity.
What evidence suggests that maridebart cafraglutide could be an effective treatment for obesity?
Research has shown that maridebart cafraglutide helps people with obesity lose weight. In one study, participants without type 2 diabetes lost an average of up to 20% of their body weight. Another study found that individuals with obesity lost up to 19.9% of their weight, while those with both obesity and type 2 diabetes lost 17%. These findings suggest that maridebart cafraglutide can significantly aid weight loss in people with obesity, regardless of diabetes status.13678
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
This trial is for adults over 18 who are obese or overweight with a BMI of at least 30, or between 27 and 30 if they have related health issues like high blood pressure. Participants should have tried losing weight unsuccessfully before.Inclusion Criteria
Exclusion 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