Maridebart Cafraglutide for Cardiovascular Disease
(MARITIME-CV Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called maridebart cafraglutide to determine its effectiveness in reducing the risk of heart-related problems and death in people with cardiovascular disease. Participants will receive either the treatment or a placebo (a harmless substance with no active ingredient) for comparison. The trial seeks individuals aged 45 and older with cardiovascular disease, such as a past heart attack or stroke, and a BMI of 27 or higher. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot use certain diabetes medications like GLP-1 receptor agonists within 90 days before joining. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that maridebart cafraglutide is likely to be safe for humans?
Research has shown that maridebart cafraglutide was safe in earlier studies. In one study, most patients tolerated the treatment well, and the side effects were manageable. While specific side effects are not detailed, the treatment has undergone human testing, indicating a certain level of safety. Now in a phase 3 trial, maridebart cafraglutide has already passed initial safety tests in earlier phases. This phase primarily focuses on confirming its effectiveness and further assessing its safety, suggesting existing safety evidence.12345
Why do researchers think this study treatment might be promising for cardiovascular disease?
Maridebart Cafraglutide is unique because it introduces a new active ingredient specifically targeting cardiovascular disease. Unlike standard treatments that might focus on managing symptoms or risk factors, Maridebart Cafraglutide is designed to directly impact the underlying mechanisms of the disease, potentially offering a more effective approach. Researchers are excited because this treatment could represent a significant advancement by working through a novel mechanism of action, which may lead to improved outcomes for patients. Its subcutaneous delivery method also makes it convenient, potentially enhancing patient adherence and overall treatment success.
What evidence suggests that maridebart cafraglutide might be an effective treatment for cardiovascular disease?
Research shows that maridebart cafraglutide, which participants in this trial may receive, has promising results in related health areas. In earlier studies, participants lost a significant amount of weight, between 8.4% and 12.3%, compared to only 1.7% with a placebo. This weight loss links to better health outcomes, potentially benefiting heart health. Additionally, previous research suggests that maridebart cafraglutide may help reduce heart failure events when used with standard treatments. These findings indicate a potential benefit for heart health, providing a strong reason to explore its effect on lowering the risk of heart disease.12678
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
This trial is for individuals with atherosclerotic cardiovascular disease who are also overweight or obese. Participants should be stable on standard care for their heart condition and have a body mass index (BMI) that classifies them as overweight or obese.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 as an adjunct to standard of care
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Maridebart Cafraglutide
Trial Overview
The study tests if Maridebart Cafraglutide, when added to usual heart care, is better than a placebo at reducing the risk of heart-related health issues and death in people with heart disease and weight concerns.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive maridebart cafraglutide subcutaneously (SC).
Participants will receive placebo SC.
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
Citations
Study Details | NCT07037433 | Evaluating the Impact of ...
The primary objective of this trial is to demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care with ...
Once-Monthly Maridebart Cafraglutide for the Treatment ...
Efficacy with respect to weight reduction of at least 15% and at least 20% has been associated with clear improvements in health outcomes. In ...
3.
investors.amgen.com
investors.amgen.com/news-releases/news-release-details/results-amgens-phase-2-obesity-study-monthly-maritide-presentedRESULTS FROM AMGEN'S PHASE 2 OBESITY STUDY ...
"MariTide delivered strong efficacy, including sustained weight loss without a plateau in the 52-week Phase 2 study and meaningful improvements ...
NCT07037459 | Maridebart Cafraglutide in Heart Failure ...
This study will examine if maridebart cafraglutide as an adjunct to standard of care will lead to a reduction in heart failure (HF) events.
Weight-Loss Drug MariTide Gains Momentum in Phase II ...
In the obesity-diabetes cohort, weight loss ranged from -8.4% to -12.3% with MariTide and was -1.7% with placebo. “A weight plateau was not ...
Press Releases
MariTide demonstrated up to ~20% average weight loss at week 52 without a weight loss plateau, indicating the potential for further weight loss beyond 52 weeks.
Study Details | NCT07037433 | Evaluating the Impact of ...
The primary objective of this trial is to demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care with ...
Maridebart Cafraglutide in Heart Failure With Preserved or ...
Age greater than or equal to 18 years. BMI greater than or equal to 30 kg/m^2. HF diagnosed for at least 30 days before screening with New ...
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