A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight

What Was Tested

The trial (phase 2) is built around MariTide (Maridebart Cafraglutide).

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

Participants will receive maridebart cafraglutide as a subcutaneous (SC) injection every 4 weeks (Q4W) for 52 weeks.

Participants will receive placebo as a SC injection Q4W for 52 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 180 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. Body Mass index (BMI) ≥ 27 kg/m\^2 to ≤ 40 kg/m\^2 at screening. For participants with type 2 diabetes mellitus (T2DM) at screening:. Treated with diet and exercise alone and/or a stable treatment with metformin, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, or combination. Liver Controlled Attenuation Parameter (CAPTM) ≥ 300 dB/meter via FibroScan® assessment.

The full record lists 9 inclusion and 13 exclusion criteria; among the exclusions: recent or planned surgical/device-based obesity treatment (\<1 year); history of malignancy within the past 5 years (exceptions apply); type 1 diabetes or non-type 2 diabetes mellitus (t2dm); unstable/severe hypoglycemia.

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 2026-03-05 with completion listed for 2027-08-25.

It ran at 23 sites in United States (23).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) at Week 52 (time frame: Baseline and Week 52). Percent Change from Baseline in Body Weight at Week 52 (time frame: Baseline and Week 52).

It also tracked 23 secondary outcomes, for example Percent Change from Baseline in Visceral Adipose Tissue (VAT) Volume by MRI at Week 52, Change from Baseline in LFC by MRI at Week 52, Percent Change from Baseline in LFC by MRI at Week 24, Change from Baseline in LFC by MRI at Week 24, Percent Change from Baseline in Thigh Muscle Volume by MRI at Week 24 and Week 52 and Percent Change from Baseline in Thigh Muscle Fat Fraction by MRI at Week 24 and Week 52.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of MariTide (Maridebart Cafraglutide) in 180 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.