Efficacy and Safety of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity Disease

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

Enrollment: 279 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. For both BMI categories, at least 1 of the weight-related comorbidities must be hypertension, dyslipidemia, or T2DM according to the definitions below:. Hypertension: treated, or with SBP ≥ 140 mmHg, or DBP ≥ 90 mmHg at screening. In the opinion of the investigator, well-motivated and willing to:.

The full record lists 10 inclusion and 9 exclusion criteria; among the exclusions: obesity induced by other endocrinological disorders or monogenetic or syndromic forms of obesity; self-reported change in body weight \> 5 kg within 90 days before screening; previous or planned (during the study) surgical, endoscopic, or device-based treatment for obesity.

How the Study Was Run

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

The participants were allocated by chance, so the MariTide (Maridebart Cafraglutide) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2025-06-13 with completion listed for 2027-04-27.

It ran at 30 sites in Japan (30).

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 30 secondary outcomes, for example Change From Baseline in Waist Circumference at Week 72, Change From Baseline in Body Weight at Week 72, Percent Change From Baseline in Body Weight in Participants Without Type 2 Diabetes Mellitus (T2DM) at Week 72, Percent Change From Baseline in Body Weight in Participants With T2DM at Week 72, Change From Baseline in Body Mass Index (BMI) at Week 72 and Change From Baseline in Visceral Fat Area (VFA) at Week 72.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of MariTide (Maridebart Cafraglutide) in 279 people.

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.