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)
Recruiting · NCT07575399 · Interventional (participants receive a specific treatment) · Lead sponsor: Amgen
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Efficacy, safety and tolerability of switching from GLP-1RA to maridebart cafraglutide in adults with obesity or overweight.
Who can take part
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
45 locations listed across 18 US states.
- Cahaba Research, Inc. - Pelham, Alabama, United States
- Arizona Clinical Trials - Chandler, Arizona, United States
- Epic Medical Research - Sun City - Sun City, Arizona, United States
- Desert Oasis Healthcare Medical Group - Palm Springs, California, United States
- Inland Empire Liver Foundation - Rialto, California, United States
- Peninsula Research Associates - Rolling Hills Estates, California, United States
- Apex Clinical Research - San Diego, California, United States
- Southern California Clinical Research - Santa Ana, California, United States
- University of Florida Department of Medicine - Gainesville, Florida, United States
- Aga Clinical Trials - Hialeah, Florida, United States
- South Florida Clinical Research - Margate, Florida, United States
- New Horizon Research Center - Miami, Florida, United States
- Research Institute of South Florida - Miami, Florida, United States
- Clinical Neuroscience Solutions - Orlando, Florida, United States
- Florida Institute for Clinical Research - Orlando, Florida, United States
- Progressive Medical Research - Port Orange, Florida, United States
- Charter Research - The Villages - The Villages, Florida, United States
- Nsc Research - Johns Creek, Georgia, United States
- Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group - Union City, Georgia, United States
- North Georgia Clinical Research - Woodstock, Georgia, United States
- Solaris Clinical Research - Meridian, Idaho, United States
- Endeavor Health - Skokie, Illinois, United States
- Pennington Biomedical Research Center - Baton Rouge, Louisiana, United States
- Arcturus Healthcare, Public Limited Company, Troy Internal Medicine Research Division - Troy, Michigan, United States
- Sky Integrative Medical Center - Ridgeland, Mississippi, United States
- Montana Medical Research - Missoula, Montana, United States
- Excel Clinical Research - Las Vegas, Nevada, United States
- Icahn School of Medicine at Mount Sinai - New York, New York, United States
- Rochester Clinical Research - Rochester, New York, United States
- Centricity Research Morehead City Specialty - Morehead City, North Carolina, United States
- Accellacare of Raleigh - Raleigh, North Carolina, United States
- Accellacare Research of Wilmington - Wilmington, North Carolina, United States
- Epic Medical Research - Oklahoma - Chickasha, Oklahoma, United States
- Lynn Health Science Institute - Oklahoma City, Oklahoma, United States
- Altoona Center for Clinical Research - Duncansville, Pennsylvania, United States
- Epic Medical Research - DeSoto - DeSoto, Texas, United States
- South Texas Research Institute - Edinburg, Texas, United States
- Biopharma Informatic, LLC - Houston, Texas, United States
- Research Physicians Network, LLC - Houston, Texas, United States
- Texas Institute of Cardiology - McKinney, Texas, United States
- North Hills Medical Research - North Richland Hills, Texas, United States
- VIP Trials - San Antonio, Texas, United States
- Northwest Houston Heart Center - Tomball, Texas, United States
- Eastside Research Associates Health Research - Redmond, Washington, United States
- Puerto Rico Medical Research Inc. - Ponce, Puerto Rico