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Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes
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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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. * Participants who are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema. * Participants who have a diagnosis of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy. * 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. * History of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. * 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.
About the study
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.
What is being tested
- Maridebart cafraglutide (drug)
- Semaglutide (drug)
Sponsor: Amgen · Participants: 1,300 · Started: Oct 16, 2026
Contact the study team
- Amgen Call Center · Phone: 866-572-6436
Official record on ClinicalTrials.gov — NCT07866066
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.