Single and Multiple Ascending Dose Study of AMG 133 in Participants With Obesity

What Was Tested

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

It had five arms (groups): Part A: maridebart cafraglutide (experimental), Part A: Placebo (placebo comparator), Part B: maridebart cafraglutide (experimental), Part B: Placebo (placebo comparator) and Part C: maridebart cafraglutide (experimental).

The registry classes the interventions as biological and drug.

Who Took Part

Enrollment: 110 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: Participant has provided informed consent before initiation of any study-specific activities/procedures. Age ≥ 18 years to ≤ 65 years, at the time of signing the informed consent. Body mass index between ≥ 30.0 kg/m\^2 and ≤ 40.0 kg/m\^2. Have a stable body weight (\< 5 kg self-reported change during the previous 8 weeks) before screening. Females must be of nonreproductive potential.

The full record lists 12 inclusion and 47 exclusion criteria; among the exclusions: screening calcitonin ≥ 50 ng/l; participants with a history of confirmed chronic pancreatitis or idiopathic acute pancreatitis; participants with a history of gall bladder disease (ie, cholelithiasis or cholecystitis) not treated with cholecystectomy.

How the Study Was Run

Design: randomized, sequential and quadruple-blind.

The participants were allocated by chance, so the MariTide (Maridebart Cafraglutide) group and the comparison group should start out alike.

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, care provider, investigator and outcomes assessor.

It started in 2020-08-07 with completion listed for 2022-11-18.

It ran at 3 sites in United States (3).

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days).

It also tracked 7 secondary outcomes, for example Part A: Maximum Observed Concentration (Cmax) of AMG 133, Part B: Cmax of AMG 133, Part A: Time of Maximum Observed Concentration (Tmax) of AMG 133, Part B: Tmax of AMG 133, Part A: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of AMG 133 and Part B: AUC From Day 0 to 28 (AUC0-28) of AMG 133.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of MariTide (Maridebart Cafraglutide) in 110 people.

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.