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)

June 10, 2026 updated by: Amgen

A Phase 3, Open-label Trial to Evaluate the Efficacy, Safety and Tolerability of Switching From the Glucagon-like Peptide-1 Receptor Agonists to Maridebart Cafraglutide in Adult Participants With Obesity or Overweight

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Puerto Rico
      • Ponce, Puerto Rico, 00717
        • Recruiting
        • Puerto Rico Medical Research Inc.
  • United States
    • Alabama
      • Pelham, Alabama, United States, 35124
        • Recruiting
        • Cahaba Research, Inc.
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Recruiting
        • Arizona Clinical Trials
      • Sun City, Arizona, United States, 85351
        • Recruiting
        • Epic Medical Research - Sun City
    • California
      • Palm Springs, California, United States, 92262
        • Recruiting
        • Desert Oasis Healthcare Medical Group
      • Rialto, California, United States, 92377
        • Recruiting
        • Inland Empire Liver Foundation
      • Rolling Hills Estates, California, United States, 90274
        • Recruiting
        • Peninsula Research Associates
      • San Diego, California, United States, 92120
        • Recruiting
        • Apex Clinical Research
      • Santa Ana, California, United States, 92701
        • Recruiting
        • Southern California Clinical Research
    • Florida
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • AGA Clinical Trials
      • Margate, Florida, United States, 33063
        • Recruiting
        • South Florida Clinical Research
      • Miami, Florida, United States, 33165
        • Recruiting
        • New Horizon Research Center
      • Miami, Florida, United States, 33173
        • Recruiting
        • Research Institute of South Florida
      • Orlando, Florida, United States, 32801
        • Recruiting
        • Clinical Neuroscience Solutions
      • Orlando, Florida, United States, 32825
        • Recruiting
        • Florida Institute for Clinical Research
      • Port Orange, Florida, United States, 32127
        • Recruiting
        • Progressive Medical Research
      • The Villages, Florida, United States, 32162
        • Recruiting
        • Charter Research - The Villages
    • Georgia
      • Johns Creek, Georgia, United States, 30024
        • Recruiting
        • NSC Research
      • Union City, Georgia, United States, 30291
        • Recruiting
        • Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
      • Woodstock, Georgia, United States, 30189
        • Recruiting
        • North Georgia Clinical Research
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Recruiting
        • Solaris Clinical Research
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Recruiting
        • Endeavor Health
    • Michigan
      • Troy, Michigan, United States, 48098
        • Recruiting
        • Arcturus Healthcare, Public Limited Company, Troy Internal Medicine Research Division
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157
        • Recruiting
        • SKY Integrative Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Recruiting
        • Excel Clinical Research
    • New York
      • Rochester, New York, United States, 14609
        • Recruiting
        • Rochester Clinical Research
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • Centricity Research Morehead City Specialty
      • Raleigh, North Carolina, United States, 27609
        • Recruiting
        • Accellacare of Raleigh
      • Wilmington, North Carolina, United States, 28401
        • Recruiting
        • Accellacare Research of Wilmington
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Recruiting
        • Lynn Health Science Institute
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Recruiting
        • Altoona Center For Clinical Research
    • Texas
      • DeSoto, Texas, United States, 75115
        • Recruiting
        • Epic Medical Research - DeSoto
      • Edinburg, Texas, United States, 78539
        • Recruiting
        • South Texas Research Institute
      • Houston, Texas, United States, 77043
        • Recruiting
        • Biopharma Informatic, LLC
      • Houston, Texas, United States, 77089
        • Recruiting
        • Research Physicians Network, LLC
      • McKinney, Texas, United States, 75071
        • Recruiting
        • Texas Institute of Cardiology
      • North Richland Hills, Texas, United States, 76180
        • Recruiting
        • North Hills Medical Research
      • San Antonio, Texas, United States, 78230
        • Recruiting
        • VIP Trials
      • Tomball, Texas, United States, 77375
        • Recruiting
        • Northwest Houston Heart Center
    • Washington
      • Redmond, Washington, United States, 98052
        • Recruiting
        • Eastside Research Associates Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MariTide Arm 1
Participants will receive maridebart cafraglutide dosing schedule 1 during the treatment period.
Drug: Maridebart Cafraglutide
Maridebart cafraglutide will be administered via subcutaneous (SC) injection.
Other Names:
  • AMG 133
Experimental: MariTide Arm 2
Participants will receive maridebart cafraglutide dosing schedule 2 during the treatment period.
Drug: Maridebart Cafraglutide
Maridebart cafraglutide will be administered via subcutaneous (SC) injection.
Other Names:
  • AMG 133

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in Body Weight at Week 68
Time Frame: Week 68
Week 68

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Change in Body Weight Prior to the Start of Weekly GLP-1RA at Week 68
Time Frame: Week 68
Week 68
Percentage of Participants Maintaining ≥ 80% of the Body Weight Reduction Achieved with Prior Weekly GLP-1RA Treatment at Week 68
Time Frame: Week 68
Week 68
Percent Maintenance of the Body Weight Reduction Achieved with Prior Weekly GLP-1RA Treatment at Week 68
Time Frame: Week 68
Week 68
Plasma Concentration of Maridebart Cafraglutide at Week 68
Time Frame: Week 68
Week 68
Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events
Time Frame: Up to 84 weeks
Up to 84 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2026

Primary Completion (Estimated)

January 3, 2028

Study Completion (Estimated)

February 28, 2028

Study Registration Dates

First Submitted

May 4, 2026

First Submitted That Met QC Criteria

May 4, 2026

First Posted (Actual)

May 8, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20250036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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