A Trial to Assess Bioavailability of AMG 133 in Participants With Overweight or Obesity

What Was Tested

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

It had three arms (groups): Group 1 (reference): AMG 133 Concentration A (frozen liquid) (experimental), Group 2 (test): AMG 133 Concentration B (liquid) (experimental) and Group 3 (test): AMG 133 Concentration C (liquid) (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 154 actual participants took part.

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

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

Examples of who could join: Provide signed and dated informed consent before any study procedures. Be male or female, 18 to 65 years old, at screening. Body mass index (BMI) between 25 and 40 kg/m² at screening. Stable body weight (less than 5 kg change by self-report) during the 3 months before screening. No major changes in diet or lifestyle (such as new weight-loss or exercise programs) during the past 3 months.

The full record lists 6 inclusion and 42 exclusion criteria; among the exclusions: endocrine disorders that can cause obesity (for example, cushing's syndrome); cancer within 5 years (except treated non-melanoma skin cancer or in-situ cervical/breast lesions); 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 open-label.

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.

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 2024-11-26 with completion listed for 2025-05-22.

It ran at 4 sites in United States (4).

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 (AUC) 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, randomized trial of MariTide (Maridebart Cafraglutide) in 154 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.