Recruiting

Phase 3

Maridebart CafraglutideEfficacy, 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)

Sponsor:

Amgen

Code:

NCT07575399

Conditions

Obesity or Overweight

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Maridebart Cafraglutide

Study Details

Brief summary:

Efficacy, safety and tolerability of switching from GLP-1RA to maridebart cafraglutide in adults with obesity or overweight.

Conditions

Obesity or Overweight

Study ID

NCT07575399

Start date

May 11, 2026

Status verified date

Aug, 2026

Completion date

Feb 28, 2028

Anticipated

Primary completion date

Jan 3, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Body Mass Index (BMI) ≥ 25 at screening.
Weight loss of ≥ 10% on weekly GLP-1 RA.
Stable body weight.
Stable dose of GLP-1RA.
Stable gastrointestinal (GI) tolerability.
Contraception for females.
Willingness to follow trial procedures for the duration of the trial.

Exclusion Criteria:

Obesity induced by other endocrine disorders (ex: Cushing's syndrome).
Previous or planned surgical, endoscopic or device-based treatment for obesity.
History of malignancy.
Type 1/Type 2 diabetes mellitus (DM).
Family or personal history of medullary thyroid cancer.
Previous participation in a Maridebart Cafraglutide trial.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MariTide Arm 1

Participants will receive maridebart cafraglutide dosing schedule 1 during the treatment period.

experimental: MariTide Arm 2

Participants will receive maridebart cafraglutide dosing schedule 2 during the treatment period.

Interventions

Maridebart Cafraglutide

Maridebart cafraglutide will be administered via subcutaneous (SC) injection.

Primary outcome measure

Percent Change from Baseline in Body Weight at Week 68 [ Time Frame: Week 68 ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436 medinfo@amgen.com

Locations

Cahaba Research, Inc.

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Pelham, Alabama, United States, 35124

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More Information

Sponsor

Amgen

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by Amgen on 2026-08-27.