A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2)

Amgen K.K.0 个研究点目标入组 999 人开始时间: 2025年3月17日最近更新: 2025年4月28日

试验速览

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•Age >= 18 years.
•Body mass index >= 27 kg/m^
•History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
•Diagnosis of T2DM.

•Type 1 diabetes mellitus.
•Self-reported change in body weight > 5 kg within 90 days before screening.
•Proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment.
•Obesity induced by other endocrinologic disorders.
•Family (first-degree relative[s]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type
•History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.
•History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
•Lifetime history of suicide attempt.

1. Percent Change from Baseline in Body Weight at Week 72 [Time Frame: Baseline and Week 72]

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