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)

NCT07575399 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: 20250036
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Obesity or Overweight

Outcome Measures

Primary Outcomes (1)

• Percent Change from Baseline in Body Weight at Week 68

  Week 68

Secondary Outcomes (5)

• Percent Change in Body Weight Prior to the Start of Weekly GLP-1RA at Week 68

  Week 68

• Percentage of Participants Maintaining ≥ 80% of the Body Weight Reduction Achieved with Prior Weekly GLP-1RA Treatment at Week 68

  Week 68

• Percent Maintenance of the Body Weight Reduction Achieved with Prior Weekly GLP-1RA Treatment at Week 68

  Week 68

• Plasma Concentration of Maridebart Cafraglutide at Week 68

  Week 68

• Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events

  Up to 84 weeks

Study Arms (2)

MariTide Arm 1

EXPERIMENTAL

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

Drug: Maridebart Cafraglutide

MariTide Arm 2

EXPERIMENTAL

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

Drug: Maridebart Cafraglutide

Interventions

Maridebart Cafraglutide DRUG

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

Also known as: AMG 133

MariTide Arm 1; MariTide Arm 2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): May 25, 2026
• Primary Completion (Estimated): January 3, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this trial will be considered beginning 18 months after the trial has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this trial.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/trials in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.