A Study to Evaluate the Effect of Maridebart Cafraglutide on Insulin Sensitivity and β-cell Function in Participants With Type 2 Diabetes Mellitus

What Was Tested

The trial (phase 1) is built around MariTide (Maridebart Cafraglutide).

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

56 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Informed consent before initiation of any study-specific activities/procedures. Male or female participants aged ≥ 18 and ≤ 70 years at the time of signing informed consent. Body mass index ≥ 23.0 kg/m\^2 (Asian participants only) or ≥ 25 and ≤ 45 kg/m\^2 at screening. Diagnosis of T2DM at least 6 months before screening based on the WHO classification.

The full record lists 5 inclusion and 27 exclusion criteria; among the exclusions: type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma, or any other type of diabetes mellitus (except t2dm or history of gestational diabetes); history of proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy that requires acute treatment; history of malignancy within the last 5 years before screening (except nonmelanoma skin cancers, cervical carcinoma in situ, or breast ductal carcinoma in situ).

How the Study Was Run

The set-up was 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.

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 2025-08-05 with completion listed for 2026-11-15.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change from Baseline in M-value from Hyperinsulinemic-euglycemic Clamp at Week 25 (time frame: Baseline and Week 25).

It also tracked 38 secondary outcomes, for example Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events, Plasma Concentration of Maridebart Cafraglutide at Week 25, Number of Participants with Anti-maridebart Cafraglutide Antibody Formation, Change from Baseline in Total Insulin Secretion at Week 25, Change from Baseline in First Phase Incremental ISR from Hyperglycemic Clamp (ISR0-8min) at Week 25 and Change from Baseline in Second Phase Insulin Secretion at Week 25.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of MariTide (Maridebart Cafraglutide) in 56 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.