A Trial to Assess the Effect of Kidney Impairment on How AMG 133 is Absorbed, Broken Down, and Eliminated by the Body

What Was Tested

The trial (phase 1) is built around MariTide (Maridebart Cafraglutide).

It had five arms (groups): Group 1: Normal renal function (experimental), Group 2: Mild renal impairment (experimental), Group 3: Moderate renal impairment (experimental), Group 4: Severe renal impairment and kidney failure not receiving hemodialysis (experimental) and Group 5: Kidney failure receiving hemodialysis (experimental).

The registry classes the interventions as drug.

Who Took Part

44 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: Male or female, of any race, between 18 and 75 years of age, inclusive. Body mass index \> 22.0 kg/m2. Eligible participants classified based on eGFR at screening and established need for renal replacement therapy as applicable. Participants with renal impairment may have medical findings consistent with their renal dysfunction.

The full record lists 5 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; history of hypersensitivity, intolerance, or allergy to amg 133 or its ingredients or to related/similar compounds.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

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 2025-03-11 with completion listed for 2025-11-21.

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

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Maximum Observed Concentration (Cmax) of AMG 133 (time frame: Up to Day 120). Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of AMG 133 (time frame: Up to Day 120). AUC From Time 0 Extrapolated to Infinity (AUCinf) 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 Antibody Formation.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of MariTide (Maridebart Cafraglutide) in 44 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.