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)

Amgen

Status and phase: Enrolling; Phase 3

Conditions: Obesity or Overweight

Treatments: Drug: Maridebart Cafraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07575399

20250036

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

MariTide Arm 1

Experimental group

Description:

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

Treatment:

Drug: Maridebart Cafraglutide

MariTide Arm 2

Experimental group

Description:

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

Treatment:

Drug: Maridebart Cafraglutide