NCT07866066
Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes
Recruiting · Phase 3 · Amgen · registry updated 2026-11-05
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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
- 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.