Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

What Was Tested

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

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

1105 actual participants took part.

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. Body mass index ≥ 27 kg/m\^2. History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise. Diagnosis of T2DM.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: type 1 diabetes mellitus; self-reported change in body weight \> 5 kg within 90 days before screening; proliferative diabetic retinopathy or diabetic macular edema or non-proliferative diabetic retinopathy that requires acute treatment.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The 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.

Blinding on both sides kept the participants and researchers unaware of who received MariTide (Maridebart Cafraglutide).

Those kept unaware of assignments: participant and investigator.

It started in 2025-03-17 with completion listed for 2027-01-21.

It ran at 187 sites in United States (59), Germany (20), Canada (19), Poland (12), South Korea (12) and Czechia (11).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent Change from Baseline in Body Weight at Week 72 (time frame: Baseline and Week 72).

It also tracked 28 secondary outcomes, for example Change from Baseline in Waist Circumference at Week 72, Change from Baseline in Systolic Blood Pressure (SBP) at Week 72, Percent Change from Baseline in Fasting Triglycerides at Week 72, Change from Baseline in Fasting Plasma Glucose at Week 72, Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72 and Change from Baseline in Body Weight at Week 72.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of MariTide (Maridebart Cafraglutide) in 1105 people.

With 1105 participants it is a large trial for this field.

Its status is active not 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.