A Study to Evaluate the Efficacy, Safety & Tolerability of Maridebart Cafraglutide in Adults With T2DM

Amgen K.K.0 个研究点目标入组 350 人开始时间: 2024年11月7日最近更新: 2025年6月10日

试验速览

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•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

•Type 1 diabetes
•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.
•Uncontrolled and potentially unstable diabetic retinopathy or maculopathy
•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
•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.
•Use of medications that affect glucose control or body weight or history of bariatric surgery or procedures.

1.Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) [Time Frame: Baseline to Week 24]

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