Comparing the Extent to Which Two Maridebart Cafraglutide Drug Products Are Made Available in the Body After a Single Subcutaneous Dose

What Was Tested

In this phase 1 trial, researchers set out to test MariTide (Maridebart Cafraglutide).

It had two arms (groups): Maridebart Cafraglutide (Test) (experimental) and Maridebart Cafraglutide (Reference) (active comparator).

Participants will receive maridebart cafraglutide (test formulation) via subcutaneous (SC) injection.

Participants will receive maridebart cafraglutide (reference formulation) via SC injection.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 340 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Male or female participants, of any race, between 18 and 60 years of age (inclusive). Females must not be pregnant or lactating. Body mass index of ≥ 25.0 to \< 40.0 kilograms per square meter (kg/m\^2). Have a stable body weight within 3 months before screening.

The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: history or evidence of endocrine disorder that can cause obesity; malignancy, except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ treated with curative intent, within the last 5 years; personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

Everyone knew when MariTide (Maridebart Cafraglutide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2026-10-12 with completion listed for 2027-03-23.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Maridebart Cafraglutide (time frame: Up to Day 120). Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration of Maridebart Cafraglutide (time frame: Up to Day 120). Maximum Observed Concentration (Cmax) of Maridebart Cafraglutide (time frame: Up to Day 120).

It also tracked 2 secondary outcomes, for example Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events and Number of Participants With Anti-Maridebart Cafraglutide Antibodies.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of MariTide (Maridebart Cafraglutide) in 340 people.

Its status is not yet 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.