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

What Was Tested

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

It had three arms (groups): one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

120 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. Male or female participants, between 18 and 65 years of age (inclusive) at the time of Screening. Body mass index ≥ 27 kg/m\^2 at the time of Screening.

The full record lists 5 inclusion and 25 exclusion criteria; among the exclusions: history or evidence of endocrine disorder (such as cushing's syndrome) that can cause obesity; malignancy except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ within the last 5 years; personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.

How the Study Was Run

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

Because people in this MariTide (Maridebart Cafraglutide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2024-08-20 with completion listed for 2024-12-27.

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

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Maximum Concentration (Cmax) of AMG 133 (time frame: Up to Day 99). Area Under the Plasma Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 133 (time frame: Day 29). Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of AMG 133 (time frame: Day 29).

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

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of MariTide (Maridebart Cafraglutide) in 120 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.