Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity

What Was Tested

The trial (phase 3) is built around MariTide (Maridebart Cafraglutide) for atherosclerosis, cardiovascular disease & high blood pressure.

It had two arms (groups): Maridebart Cafraglutide (experimental) and Placebo (placebo comparator).

Participants will receive maridebart cafraglutide subcutaneously (SC).

Participants will receive placebo SC.

The registry classes the interventions as drug.

Who Took Part

12800 planned participants were the target.

It was open to people of any sex aged from 45 years up to 99 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age ≥ 45 years at screening. BMI of ≥ 27.0 kg/m\^2 at screening. History of Atherosclerotic Cardiovascular Disease (ASCVD) with a documented history of at least one of the following:. Prior MI (presumed atherothrombotic event due to plaque rupture/erosion). Prior ischemic stroke (presumed due to atherosclerosis; may include ischemic stroke with hemorrhagic transformation).

The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: new york heart association (nyha) class iv hf during screening or hospitalization for hf within 60 days before screening or between screening and randomization; history of diabetic ketoacidosis or hyperosmolar state/coma within 12 months before randomization; one or more episodes of severe hypoglycemia within 6 months before randomization and/or history of hypoglycemia unawareness.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The atherosclerosis, cardiovascular disease & high blood pressure participants were allocated by chance, so the MariTide (Maridebart Cafraglutide) group and the comparison group should start out alike.

The MariTide (Maridebart Cafraglutide) group and the comparison group ran side by side rather than switching.

As a double-blind MariTide (Maridebart Cafraglutide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2025-07-25 with completion listed for 2028-06-30.

It ran at 783 sites in United States (140), Czechia (41), China (40), Germany (39), Poland (39) and Brazil (37).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 48 secondary outcomes, for example Time to First MI, Time to First Ischemic Stroke, Time to First Coronary Revascularization, Time to First HF Event, Time to First Unstable Angina Requiring Hospitalization and Total Major Ischemic Events (Time to First and Recurrent MI or Ischemic Stroke).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of MariTide (Maridebart Cafraglutide) in 12800 people with atherosclerosis, cardiovascular disease & high blood pressure.

With 12800 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the MariTide (Maridebart Cafraglutide) compound page, Atherosclerosis, cardiovascular disease & high blood pressure research.