Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Participants

What Was Tested

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

It had five arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 34 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy male or female participants between 18 and 65 years of age (inclusive) at the time of Screening (Japanese participants must be first-generation Japanese). Body mass index between 18 and 30 kg/m\^2 at the time of Screening. Females of nonchildbearing potential.

The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: history or current signs or symptoms of cardiovascular disease; history of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance; positive hepatitis b or hepatitis c panel and/or positive human immunodeficiency virus test at screening.

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.

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

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

It started in 2021-09-10 with completion listed for 2022-04-08.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Maximum Observed Plasma Concentration (Cmax) of Intact AMG 133. Cmax of Total AMG 133. Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of Intact AMG 133.

It also tracked 2 secondary outcomes, for example Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) and Number of Participants With a Positive Anti-AMG 133 Binding Antibody Result.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of MariTide (Maridebart Cafraglutide) in 34 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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