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)
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
1 other identifier
interventional
300
2 countries
44
Brief Summary
Efficacy, safety and tolerability of switching from GLP-1RA to maridebart cafraglutide in adults with obesity or overweight.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2026
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2026
CompletedFirst Posted
Study publicly available on registry
May 8, 2026
CompletedStudy Start
First participant enrolled
May 11, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 3, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2028
July 23, 2026
July 1, 2026
1.6 years
May 4, 2026
July 22, 2026
Conditions
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
EXPERIMENTALParticipants will receive maridebart cafraglutide dosing schedule 1 during the treatment period.
MariTide Arm 2
EXPERIMENTALParticipants will receive maridebart cafraglutide dosing schedule 2 during the treatment period.
Interventions
Maridebart cafraglutide will be administered via subcutaneous (SC) injection.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (44)
Cahaba Research, Inc.
Pelham, Alabama, 35124, United States
Arizona Clinical Trials
Chandler, Arizona, 85224, United States
Epic Medical Research - Sun City
Sun City, Arizona, 85351, United States
Desert Oasis Healthcare Medical Group
Palm Springs, California, 92262, United States
Inland Empire Liver Foundation
Rialto, California, 92377, United States
Peninsula Research Associates
Rolling Hills Estates, California, 90274, United States
Apex Clinical Research
San Diego, California, 92120, United States
Southern California Clinical Research
Santa Ana, California, 92701, United States
University of Florida Department of Medicine
Gainesville, Florida, 32610, United States
Aga Clinical Trials
Hialeah, Florida, 33012, United States
South Florida Clinical Research
Margate, Florida, 33063, United States
New Horizon Research Center
Miami, Florida, 33165, United States
Research Institute of South Florida
Miami, Florida, 33173, United States
Clinical Neuroscience Solutions
Orlando, Florida, 32801, United States
Florida Institute for Clinical Research
Orlando, Florida, 32825, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Charter Research - The Villages
The Villages, Florida, 32162, United States
Nsc Research
Johns Creek, Georgia, 30024, United States
Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
Union City, Georgia, 30291, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
Solaris Clinical Research
Meridian, Idaho, 83646, United States
Endeavor Health
Skokie, Illinois, 60077, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
Arcturus Healthcare, Public Limited Company, Troy Internal Medicine Research Division
Troy, Michigan, 48098, United States
Sky Integrative Medical Center
Ridgeland, Mississippi, 39157, United States
Excel Clinical Research
Las Vegas, Nevada, 89109, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
Centricity Research Morehead City Specialty
Morehead City, North Carolina, 28557, United States
Accellacare of Raleigh
Raleigh, North Carolina, 27609, United States
Accellacare Research of Wilmington
Wilmington, North Carolina, 28401, United States
Epic Medical Research - Oklahoma
Chickasha, Oklahoma, 73018, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Epic Medical Research - DeSoto
DeSoto, Texas, 75115, United States
South Texas Research Institute
Edinburg, Texas, 78539, United States
Biopharma Informatic, LLC
Houston, Texas, 77043, United States
Research Physicians Network, LLC
Houston, Texas, 77089, United States
Texas Institute of Cardiology
McKinney, Texas, 75071, United States
North Hills Medical Research
North Richland Hills, Texas, 76180, United States
VIP Trials
San Antonio, Texas, 78230, United States
Northwest Houston Heart Center
Tomball, Texas, 77375, United States
Eastside Research Associates Health Research
Redmond, Washington, 98052, United States
Puerto Rico Medical Research Inc.
Ponce, 00717, Puerto Rico
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Central Study Contacts
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
May 11, 2026
Primary Completion (Estimated)
January 3, 2028
Study Completion (Estimated)
February 28, 2028
Last Updated
July 23, 2026
Record last verified: 2026-07
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.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.