A Trial to Compare the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous Presentations

What Was Tested

This registered phase 1 trial tested MariTide (Maridebart Cafraglutide).

It had two arms (groups): Maridebart Cafraglutide SC Presentation 1 (experimental) and Maridebart Cafraglutide SC Presentation 2 (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 349 actual participants took part.

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, of any race, between 18 and 60 years of age, inclusive. Body mass index between 25.0 and \<40.0 kg/m\^2. Have a stable body weight (\<5 kg self-reported change) within 3 months before screening, as assessed by the investigator (or designee) based on participant self-report.

The full record lists 3 inclusion and 15 exclusion criteria; among the exclusions: history or evidence of endocrine disorder (eg, cushing's syndrome) that can cause obesity; malignancy, except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ, within the last 5 years; personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got MariTide (Maridebart Cafraglutide) and who got the comparison, which limits bias.

The MariTide (Maridebart Cafraglutide) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label MariTide (Maridebart Cafraglutide) study: the participants and staff both knew the treatment.

It started in 2025-12-15 with completion listed for 2026-07-02.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Infinity (AUCinf) of AMG 133 (time frame: Up to Day 120). AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of AMG 133 (time frame: Up to Day 120). Maximum Observed Plasma Concentration (Cmax) of AMG 133 (time frame: Up to Day 120).

It also tracked 3 secondary outcomes, for example Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs), Number of Participants who Experienced Serious AEs (SAEs) and Number of Participants with Positive Anti-AMG 133 Antibodies.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of MariTide (Maridebart Cafraglutide) in 349 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the MariTide (Maridebart Cafraglutide) compound page, all human trials.