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)

August 26, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida Department of Medicine
      • 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
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Recruiting
        • Pennington Biomedical Research Center
    • 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
    • Montana
      • Missoula, Montana, United States, 59808
        • Recruiting
        • Montana Medical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Recruiting
        • Excel Clinical Research
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School Of Medicine At Mount Sinai
      • 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
      • Chickasha, Oklahoma, United States, 73018
        • Recruiting
        • Epic Medical Research - 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percent Change from Baseline in Body Weight at Week 68
Time Frame: Week 68
Week 68

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 11, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 3, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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