The Effect of AMG 133 on Gastric Emptying

What Was Tested

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

It had two arms (groups): AMG 133 (experimental) and Placebo (placebo comparator).

Participants will receive AMG 133 subcutaneously (SC) and acetaminophen orally.

Participants will receive placebo SC and acetaminophen orally.

The registry classes the interventions as drug.

Who Took Part

57 actual participants took part.

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

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

Examples of who could join: Male or female participants between 18 and 65 years of age. Body mass index between ≥ 27 to \< 40 kg/m\^2.

The full record lists 2 inclusion and 20 exclusion criteria; among the exclusions: history or evidence of endocrine disorder; personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2; uncontrolled thyroid disease.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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.

As a double-blind MariTide (Maridebart Cafraglutide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2025-04-17 with completion listed for 2025-11-26.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Maximum Observed Plasma Concentration (Cmax) for Acetaminophen (time frame: Days 1, 3, 8, 17, 31, 59, 64, and 86). Time to Cmax (Tmax) for Acetaminophen (time frame: Days 1, 3, 8, 17, 31, 59, 64, and 86). Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) for Acetaminophen (time frame: Days 1, 3, 8, 17, 31, 59, 64, and 86).

It also tracked 7 secondary outcomes, for example Cmax for AMG 133, AUClast for AMG 133, AUCinf for AMG 133, Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs), Number of Participants Who Experience Serious Adverse Events (SAEs) and Change from Baseline in Food Intake and Appetite.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of MariTide (Maridebart Cafraglutide) in 57 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.