Maridebart cafraglutide compared with semaglutide for type 2 diabetes
Tests maridebart cafraglutide against semaglutide in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes
Key facts
- Where
- Arlington, Miami, Miami Lakes, Pompano Beach, Redmond, San Diego, and Winter Park, United StatesSee the 7 sites
- Phase
- Phase 3
Where in United States
- Virginia Nephrology GroupArlington, United StatesTaking people
- Bioclinical Research AllianceMiami, United StatesTaking people
- Indago Research and Health CenterMiami Lakes, United StatesTaking people
- Clinical Research Center of FloridaPompano Beach, United StatesTaking people
- Eastside Research Associates Health ResearchRedmond, United StatesTaking people
- Acclaim Clinical ResearchSan Diego, United StatesTaking people
- Conquest Research-Winter ParkWinter Park, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amgen
- Trial code
- NCT07866066EU 2025-523772-22-00
- Record updated
- 5 November 2026
- Original description
The main objective of this trial is to evaluate whether maridebart cafraglutide is non-inferior to semaglutide in improving glycemic control in participants with type 2 diabetes (T2D) who are receiving metformin treatment, with or without a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.Read full original descriptionShow less
A Phase 3, Randomized, Open-Label Trial Comparing the Efficacy and Safety of Maridebart Cafraglutide Once Monthly Versus Semaglutide Once Weekly as Add-on Therapy to Metformin With or Without a Sodium-glucose Cotransporter-2 Inhibitor in Participants With Type 2 Diabetes
The main objective of this trial is to evaluate whether maridebart cafraglutide is non-inferior to semaglutide in improving glycemic control in participants with type 2 diabetes (T2D) who are receiving metformin treatment, with or without a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.
Inclusion: HbA1c of ≥ 7.5% (58.0 millimoles per mole (mmol/mol)) and ≤ 10.5% (91.0 mmol/mol) at screening; Treatment of Type 2 diabetes (T2D) with metformin (≥ 1500 milligrams per day (mg/day), or maximum tolerated dose as per investigator judgment) with or without an sodium-glucose cotransporter-2 (SGLT-2) inhibitor on a stable total daily dose for at least 90 days prior to randomization; Body mass index (BMI) ≥ 25 kilograms per meter squared (kg/m\^2) at screening.
Exclusion: Participants who are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema; One or more episode of severe hypoglycemia (Level 3 hypoglycemia) within 180 days before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery; Self-reported change in body weight > 5% within 90 days before screening. Participants must also agree to not initiate an intensive diet or exercise program during the trial with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment; Previous or planned (during the trial) surgical, endoscopic, or device-based treatment for obesity. The following are allowed:; liposuction and/or abdominoplasty that was performed > 1 year before screening; laparoscopic adjustable gastric banding, intragastric balloon, and/or duodenal-jejunal bypass liner or gastric sleeve if removed > 1 year before screening; Type 1 diabetes mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other type of diabetes mellitus except T2D or past history of gestational diabetes; History of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms; Participants who have a diagnosis of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy.