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Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)

Plain-language guide to NCT07575399: phase 3 randomized trial of MariTide (Maridebart Cafraglutide), 300 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07575399
Phase
phase 3
Status
recruiting participants
Start
2026-05-11
Completion (planned or actual)
2028-01-03
Participants
300 (estimated)
Design
randomized, double-blind, treatment
Conditions studied
Obesity or Overweight
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 3 trial, researchers set out to test MariTide (Maridebart Cafraglutide).

It had two arms (groups): MariTide Arm 1 (experimental) and MariTide Arm 2 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 300 planned participants were the target.

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: Body Mass Index (BMI) ≥ 25 at screening. Stable body weight. Stable gastrointestinal (GI) tolerability. Contraception for females. Willingness to follow trial procedures for the duration of the trial.

The full record lists 7 inclusion and 6 exclusion criteria; among the exclusions: obesity induced by other endocrine disorders (ex: cushing's syndrome); previous or planned surgical, endoscopic or device-based treatment for obesity; history of malignancy.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

The MariTide (Maridebart Cafraglutide) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received MariTide (Maridebart Cafraglutide).

Those kept unaware of assignments: participant and investigator.

It started in 2026-05-11 with completion listed for 2028-01-03.

It ran at 54 sites in United States (53) and Puerto Rico (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent Change from Baseline in Body Weight at Week 68 (time frame: Week 68).

It also tracked 5 secondary outcomes, for example Percent Change in Body Weight Prior to the Start of Weekly GLP-1RA at Week 68, Plasma Concentration of Maridebart Cafraglutide at Week 68 and Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of MariTide (Maridebart Cafraglutide) in 300 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the MariTide (Maridebart Cafraglutide) compound page, all human trials.

Our Notes on the Compound

MariTide (Maridebart Cafraglutide): Amgen's once-monthly antibody-peptide conjugate that blocks GIP receptors and activates GLP-1 receptors, in phase 3 obesity trials. News and evidence page only.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.