Evaluation of Maridebart Cafraglutide in Adult Participants Without 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

3853 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. History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: type 1 or typ2 diabetes mellitus; obesity induced by other endocrinologic disorders; self-reported change in body weight \> 5 kg within 90 days before screening.

How the Study Was Run

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

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 2025-03-12 with completion listed for 2027-01-21.

It ran at 243 sites in United States (74), Germany (30), South Korea (19), United Kingdom (15), Canada (12) and Poland (12).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent Change From Baseline in Body Weight at Week 72 (time frame: Baseline and Week 72).

It also tracked 20 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 Glucose at Week 72, Change From Baseline in Body Weight at Week 72 and Change From Baseline in Body Mass Index (BMI) at Week 72.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of MariTide (Maridebart Cafraglutide) in 3853 people.

With 3853 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.