A Study to Evaluate AMG 133 in Chinese Participants With Obesity or Overweight

What Was Tested

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

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 20 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: Provide signed informed consent. Participants must be of Chinese ancestry with biological parents and all 4 grandparents of Chinese ancestry. Male or female participants, between 18 and 65 years of age (inclusive) at the time of Screening. Female participants must be of nonchildbearing potential. Body mass index between 24 and 40 kg/m\^2 (inclusive) at the time of Screening. Have a stable body weight (\<5 kg self-reported change) within 3 months before Screening.

The full record lists 7 inclusion and 24 exclusion criteria; among the exclusions: history or evidence of endocrine disorder (such as cushing's syndrome) that can cause obesity; previous surgical procedure for obesity (excluding liposuction if performed \>1 year before study entry) within past 6 months from check-in; history or current signs or symptoms of cardiovascular disease.

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 2024-04-25 with completion listed for 2024-08-27.

It ran at 1 site in Hong Kong.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide (time frame: Up to approximately 120 days). Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to the Last Quantifiable Concentration (AUClast) of Maridebart Cafraglutide (time frame: Up to approximately 120 days). AUC from Time Zero Extrapolated to Infinity (AUCinf) of Maridebart Cafraglutide (time frame: Up to approximately 120 days).

It also tracked 3 secondary outcomes, for example Number of Participants with Treatment-emergent Adverse Events, Number of Participants with 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 20 people.

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

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.