A Study of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus (T2DM)

Prior treatment

• Myocardial infarction, unstable angina, coronary artery bypass graft surgery or other major cardiovascular surgery, percutaneous coronary intervention, transient ischemic attack, cerebrovascular accident, or decompensated congestive heart failure within 90 days prior to screening, or currently have New York Heart Association Class III or IV heart failure.

Other illness

• Type 1 diabetes
• History of acute or chronic pancreatitis
• Malignancy within 5 years before screening, except for nonmelanoma skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer

Lab values

• Use of any glucose-lowering medication, other than metformin with or without a sodium-glucose cotransporter-2 inhibitor, within 3 months prior to screening
• Estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology equation.
• Use of medications that affect glucose control or body weight or history of bariatric surgery or procedures.

Other

• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy

• Age ≥ 18 years at screening (or ≥ legal age within the country if it is older than 18 years)
• Type 2 diabetes for ≥6 months according to the World Health Organization classification
• HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory
• Treatment of diabetes with diet and exercise alone, or with a stable dose of metformin, with or without a sodium-glucose cotransporter-2 inhibitor, for at least 3 months prior to screening
• Body mass index of 23 to 50 kilograms per square meter