Maridebart Cafraglutide for Cardiovascular Disease

(MARITIME-CV Trial)

Recruiting at 489 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Must not be taking: GLP-1 RAs, GIP agonists

Disqualifiers: Recent MI, Type 1 DM, others

Stay on Your Current Meds You can continue your current medications while participating

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 35 months

12800 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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

BMI of ≥ 27 kg/m2 at screening

I am 45 years old or older.

I have had heart disease or stroke, or issues with blood flow in my legs.

Exclusion Criteria

Participants planning pregnancy or unwilling to use contraception during treatment

I don't have hepatitis, liver disease, high liver enzymes, or recent cancer except for certain types.

I have severe heart failure or was hospitalized for it within the last 2 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive maridebart cafraglutide or placebo subcutaneously as an adjunct to standard of care

Up to approximately 35 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

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?

Group I: Maridebart Cafraglutide Experimental Treatment 1 Intervention

Participants will receive maridebart cafraglutide subcutaneously (SC).

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo SC.

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

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

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07037433

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 ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2504214

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-presented

RESULTS 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07037459

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.

5. tctmd.com tctmd.com/news/weight-loss-drug-maritide-gains-momentum-phase-ii-trial

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 ...

6. amgen.com amgen.com/newsroom/press-releases/2024/11/amgen-announces-robust-weight-loss-with-maritide-in-people-living-with-obesity-or-overweight-at-52-weeks-in-a-phase-2-study

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.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07037433

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 ...

8. ucihealth.org ucihealth.org/clinical-trials/CCR-24-187

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 ...