Obesity or OverweightPhase 3NCT07575399
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 study testing Maridebart Cafraglutide in people with Obesity or Overweight, run by Amgen at 54 sites in 2 countries.
Trial summary
Efficacy, safety and tolerability of switching from GLP-1RA to maridebart cafraglutide in adults with obesity or overweight. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Obesity or Overweight
- What is being tested?
- Maridebart Cafraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 54 sitesin 2 countries
- Study dates
- 11 May 2026to 28 Feb 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
54 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
54 sites in 2 countries
United States53 sites, 52 recruiting
- Recruiting
Pinnacle Clinical Research Georgetown
Austin, Texas, 78757
- Recruiting
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
- Recruiting
Heritage Valley Multispecialty Group Inc
Beaver, Pennsylvania, 15009
- Recruiting
East Coast Institute for Research
Canton, Georgia, 30114
- Recruiting
Arizona Clinical Trials
Chandler, Arizona, 85224
- Recruiting
Epic Medical Research - Oklahoma
Chickasha, Oklahoma, 73018
- Recruiting
Peninsula Research Associates
Chula Vista, California, 91911
- Recruiting
Epic Medical Research - DeSoto
DeSoto, Texas, 75115
- Recruiting
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
- Terminated
South Texas Research Institute
Edinburg, Texas, 78539
- Recruiting
University of Florida Department of Medicine
Gainesville, Florida, 32610
- Recruiting
Aga Clinical Trials
Hialeah, Florida, 33012
- Recruiting
Biopharma Informatic, LLC
Houston, Texas, 77043
- Recruiting
Research Physicians Network, LLC
Houston, Texas, 77089
- Recruiting
Nsc Research
Johns Creek, Georgia, 30024
- Recruiting
Mel A. Ona, M.D., Incorporated
Kapolei, Hawaii, 96707
- Recruiting
Excel Clinical Research
Las Vegas, Nevada, 89109
- Recruiting
South Florida Clinical Research
Margate, Florida, 33063
- Recruiting
Texas Institute of Cardiology
McKinney, Texas, 75071
- Recruiting
Solaris Clinical Research
Meridian, Idaho, 83646
- Recruiting
New Horizon Research Center
Miami, Florida, 33165
- Recruiting
Research Institute of South Florida
Miami, Florida, 33173
- Recruiting
Montana Medical Research
Missoula, Montana, 59808
- Recruiting
Centricity Research Morehead City Specialty
Morehead City, North Carolina, 28557
- Recruiting
Adult Medicine of Lake County
Mt. Dora, Florida, 32757
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
- Recruiting
North Hills Medical Research
North Richland Hills, Texas, 76180
- Recruiting
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
- Recruiting
Clinical Neuroscience Solutions
Orlando, Florida, 32801
- Recruiting
Florida Institute for Clinical Research
Orlando, Florida, 32825
- Recruiting
Desert Oasis Healthcare Medical Group
Palm Springs, California, 92262
- Recruiting
Cahaba Research, Inc.
Pelham, Alabama, 35124
- Recruiting
Progressive Medical Research
Port Orange, Florida, 32127
- Recruiting
Accellacare of Raleigh
Raleigh, North Carolina, 27609
- Recruiting
Eastside Research Associates Health Research
Redmond, Washington, 98052
- Recruiting
Inland Empire Liver Foundation
Rialto, California, 92377
- Recruiting
Sky Integrative Medical Center
Ridgeland, Mississippi, 39157
- Recruiting
Rochester Clinical Research
Rochester, New York, 14609
- Recruiting
American Research Corporation
San Antonio, Texas, 78215
- Recruiting
Gastroenterology Clinic of San Antonio PA
San Antonio, Texas, 78229
- Recruiting
VIP Trials
San Antonio, Texas, 78230
- Recruiting
Apex Clinical Research
San Diego, California, 92120
- Recruiting
Southern California Clinical Research
Santa Ana, California, 92701
- Recruiting
Endeavor Health
Skokie, Illinois, 60077
- Recruiting
Central Illinois Diabetes and Clinical Research, a Division of Prairie Education and Research Cooper
Springfield, Illinois, 62704
- Recruiting
Epic Medical Research - Sun City
Sun City, Arizona, 85351
- Recruiting
Clinical Research Institute of Arizona LLC
Sun City West, Arizona, 85375
- Recruiting
Charter Research - The Villages
The Villages, Florida, 32162
- Recruiting
Northwest Houston Heart Center
Tomball, Texas, 77375
- Recruiting
Arcturus Healthcare, Public Limited Company, Troy Internal Medicine Research Division
Troy, Michigan, 48098
- Recruiting
Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
Union City, Georgia, 30291
- Recruiting
Accellacare Research of Wilmington
Wilmington, North Carolina, 28401
- Recruiting
North Georgia Clinical Research
Woodstock, Georgia, 30189
Puerto Rico1 site, 1 recruiting
- Recruiting
Puerto Rico Medical Research Inc.
Ponce, 00717
About this study
Official title: 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.
- Conditions
- Obesity or Overweight
- Being tested
- Maridebart Cafraglutide
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maridebart CafraglutideDrug
Also called AMG 133
Maridebart cafraglutide will be administered via subcutaneous (SC) injection.
| Study group | Role | What they receive |
|---|---|---|
| MariTide Arm 1 | Experimental | Participants will receive maridebart cafraglutide dosing schedule 1 during the treatment period. Receives: Drug: Maridebart Cafraglutide |
| MariTide Arm 2 | Experimental | Participants will receive maridebart cafraglutide dosing schedule 2 during the treatment period. Receives: Drug: Maridebart Cafraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline in Body Weight at Week 68
Measured: Week 68
Secondary outcomes (5)
Percent Change in Body Weight Prior to the Start of Weekly GLP-1RA at Week 68
Measured: Week 68
Percentage of Participants Maintaining ≥ 80% of the Body Weight Reduction Achieved with Prior Weekly GLP-1RA Treatment at Week 68
Measured: Week 68
Percent Maintenance of the Body Weight Reduction Achieved with Prior Weekly GLP-1RA Treatment at Week 68
Measured: Week 68
Plasma Concentration of Maridebart Cafraglutide at Week 68
Measured: Week 68
Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events
Measured: Up to 84 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start11 May 2026
- Primary completion3 Jan 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity or OverweightStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575399
- Sponsor's protocol ID
- 20250036
- Status last verified
- Oct 2026
- First submitted
- 4 May 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.