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)
Purpose
Efficacy, safety and tolerability of switching from GLP-1RA to maridebart cafraglutide in adults with obesity or overweight.
Condition
- Obesity or Overweight
Eligibility
- Eligible Ages
- Between 18 Years and 99 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental MariTide Arm 1 |
Participants will receive maridebart cafraglutide dosing schedule 1 during the treatment period. |
|
|
Experimental MariTide Arm 2 |
Participants will receive maridebart cafraglutide dosing schedule 2 during the treatment period. |
|
Recruiting Locations
Cahaba Research, Inc.
Pelham, Alabama 35124
Pelham, Alabama 35124
Arizona Clinical Trials
Chandler, Arizona 85224
Chandler, Arizona 85224
Epic Medical Research - Sun City
Sun City, Arizona 85351
Sun City, Arizona 85351
Desert Oasis Healthcare Medical Group
Palm Springs, California 92262
Palm Springs, California 92262
Inland Empire Liver Foundation
Rialto, California 92377
Rialto, California 92377
Peninsula Research Associates
Rolling Hills Estates, California 90274
Rolling Hills Estates, California 90274
Apex Clinical Research
San Diego, California 92120
San Diego, California 92120
Southern California Clinical Research
Santa Ana, California 92701
Santa Ana, California 92701
Aga Clinical Trials
Hialeah, Florida 33012
Hialeah, Florida 33012
South Florida Clinical Research
Margate, Florida 33063
Margate, Florida 33063
New Horizon Research Center
Miami, Florida 33165
Miami, Florida 33165
Research Institute of South Florida
Miami, Florida 33173
Miami, Florida 33173
Clinical Neuroscience Solutions
Orlando, Florida 32801
Orlando, Florida 32801
Florida Institute for Clinical Research
Orlando, Florida 32825
Orlando, Florida 32825
Progressive Medical Research
Port Orange, Florida 32127
Port Orange, Florida 32127
Charter Research - The Villages
The Villages, Florida 32162
The Villages, Florida 32162
Nsc Research
Johns Creek, Georgia 30024
Johns Creek, Georgia 30024
Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
Union City, Georgia 30291
Union City, Georgia 30291
North Georgia Clinical Research
Woodstock, Georgia 30189
Woodstock, Georgia 30189
Solaris Clinical Research
Meridian, Idaho 83646
Meridian, Idaho 83646
Endeavor Health
Skokie, Illinois 60077
Skokie, Illinois 60077
Arcturus Healthcare, Public Limited Company, Troy Internal Medicine Research Division
Troy, Michigan 48098
Troy, Michigan 48098
Sky Integrative Medical Center
Ridgeland, Mississippi 39157
Ridgeland, Mississippi 39157
Excel Clinical Research
Las Vegas, Nevada 89109
Las Vegas, Nevada 89109
Rochester Clinical Research
Rochester, New York 14609
Rochester, New York 14609
Centricity Research Morehead City Specialty
Morehead City, North Carolina 28557
Morehead City, North Carolina 28557
Accellacare of Raleigh
Raleigh, North Carolina 27609
Raleigh, North Carolina 27609
Accellacare Research of Wilmington
Wilmington, North Carolina 28401
Wilmington, North Carolina 28401
Lynn Health Science Institute
Oklahoma City, Oklahoma 73112
Oklahoma City, Oklahoma 73112
Altoona Center for Clinical Research
Duncansville, Pennsylvania 16635
Duncansville, Pennsylvania 16635
Epic Medical Research - DeSoto
DeSoto, Texas 75115
DeSoto, Texas 75115
South Texas Research Institute
Edinburg, Texas 78539
Edinburg, Texas 78539
Biopharma Informatic, LLC
Houston, Texas 77043
Houston, Texas 77043
Research Physicians Network, LLC
Houston, Texas 77089
Houston, Texas 77089
Texas Institute of Cardiology
McKinney, Texas 75071
McKinney, Texas 75071
North Hills Medical Research
North Richland Hills, Texas 76180
North Richland Hills, Texas 76180
VIP Trials
San Antonio, Texas 78230
San Antonio, Texas 78230
Northwest Houston Heart Center
Tomball, Texas 77375
Tomball, Texas 77375
Eastside Research Associates Health Research
Redmond, Washington 98052
Redmond, Washington 98052
Puerto Rico Medical Research Inc.
Ponce, Puerto Rico 00717
Ponce, Puerto Rico 00717
More Details
- Status
- Recruiting
- Sponsor
- Amgen