Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity

What Was Tested

This registered phase 3 trial tested MariTide (Maridebart Cafraglutide).

This is a phase 3, global, multicenter, 2-part trial with a double-blind period and an open-label extension (OLE).

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

The registry lists 5056 planned participants were the target.

It was open to people of any sex aged from 18 years up to 99 years.

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

Examples of who could join: Age ≥ 18 years at the time of informed consent. BMI ≥ 30.0 kg/m\^2 at randomization. HF diagnosed for at least 30 days with New York Heart Association (NYHA) Class II-IV at the time of informed consent. Managed with HF standard of care therapies.

The full record lists 5 inclusion and 22 exclusion criteria; among the exclusions: hospitalized with acute decompensated hf at the time of or during the screening period; type 1 diabetes mellitus, or any type of diabetes with the exception of t2dm or history of gestational diabetes; for participants with a prior diagnosis of t2dm (including those diagnosed during screening):.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this MariTide (Maridebart Cafraglutide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Neither the participants nor the staff measuring them knew who was on MariTide (Maridebart Cafraglutide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

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

It ran at 657 sites in United States (121), China (52), Czechia (39), Germany (31), Hungary (27) and Poland (25).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 33 secondary outcomes, for example Change from Baseline in the KCCQ Total Symptom Score (TSS) for Participants with Baseline KCCQ-CSS Score ≤ 80, Total Number of HF Events Including First and Recurrent HF Events, Time to First Event of a Composite Nephropathy Endpoint, Change in eGFR Slope (Total), Change in eGFR Slope (Chronic) and Time to Onset of Type 2 Diabetes Mellitus (T2DM) in Participants with Prediabetes.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of MariTide (Maridebart Cafraglutide) in 5056 people.

With 5056 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, all human trials.