Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus

What Was Tested

In this phase 2 trial, researchers set out to test MariTide (Maridebart Cafraglutide).

It had four arms (groups): Cohort A: Maridebart Cafraglutide (experimental), Cohort A: Placebo (placebo comparator), Cohort B: Maridebart Cafraglutide (experimental) and Cohort B: Placebo (placebo comparator).

The registry classes the interventions as biological and drug.

Who Took Part

Enrollment: 592 actual participants took part.

It was open to people of any sex aged from 18 years up to 99 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age ≥18 years at the time of signing informed consent. BMI ≥30 kg/m\^2, or ≥27 kg/m\^2 and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease. History of at least one unsuccessful dietary effort to lose body weight.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: change in body weight greater than 5 kg within 3 months prior to screening; obesity induced by other endocrinologic disorders; history of pancreatitis.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got MariTide (Maridebart Cafraglutide) and who got the comparison, which limits bias.

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

Neither the participants nor the staff measuring them knew who was on MariTide (Maridebart Cafraglutide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2023-01-18 with completion listed for 2024-10-08.

It ran at 78 sites in United States (29), Japan (9), Australia (6), Poland (6), Canada (5) and Hungary (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent Change From Baseline to Week 52 in Body Weight (time frame: Baseline and Week 52).

It also tracked 26 secondary outcomes, for example Change from Baseline to Week 52 in Hemoglobin A1c (HbA1c), Change from Baseline to Week 52 in Fasting Serum Insulin, Change from Baseline to Week 52 in Fasting Plasma Glucose, Change from Baseline to Week 52 in Homeostasis Model Assessment for Insulin Resistance (HOMA2-IR), Change from Baseline to Week 52 in Homeostasis Model Assessment for Steady State Beta Cell Function (HOMA2-%B) and Maximum Observed Plasma Concentration (Cmax) of maridebart cafraglutide.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of MariTide (Maridebart Cafraglutide) in 592 people.

With 592 participants it is a large trial for this field.

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.