A Study to Evaluate AMG 133 in Participants With Varying Degrees of Hepatic Impairment or Normal Hepatic Function

What Was Tested

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

It had four arms (groups): Group 1, AMG 133: Normal Hepatic Function (No Impairment) (experimental), Group 2, AMG-133: Child-Pugh A (Mild Hepatic Impairment) (experimental), Group 3, AMG-133: Child-Pugh B (Moderate Hepatic Impairment) (experimental) and Group 4, AMG-133: Child-Pugh C (Severe Hepatic Impairment) (experimental).

The registry classes the interventions as drug.

Who Took Part

36 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Adults 18 to 75 years of age, male or female. Body mass index ≥ 22 kg/m\^2 at screening. For participants with normal hepatic function:. Systolic blood pressure (BP) 90-150 mmHg and diastolic BP 50-100 mmHg; pulse 40-110 bpm. Stable body weight (\< 5 kg change) and no recent dietary modifications within 3 months.

The full record lists 11 inclusion and 20 exclusion criteria; among the exclusions: any unstable medical condition (e.g., recent hospitalization or major surgery); history of acute or chronic pancreatitis within 1 year or lipase/amylase \> 2× uln at screening; endocrine disorder that can cause obesity (e.g., cushing's syndrome).

How the Study Was Run

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

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

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 2025-03-14 with completion listed for 2026-02-26.

It ran at 5 sites in United States (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Maximum Observed Plasma Concentration (Cmax) of AMG 133 (time frame: Up to Day 120). Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 133 (time frame: Up to Day 120). AUC from Time Zero to Infinity (AUCinf) of AMG 133 (time frame: Up to Day 120).

It also tracked 3 secondary outcomes, for example Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs), Number of Participants Who Experience Serious Adverse Events (SAEs) and Number of Participants Who Develop Anti-AMG 133 Antibodies.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of MariTide (Maridebart Cafraglutide) in 36 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.