A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

Amgen K.K.0 个研究点目标入组 3,501 人开始时间: 2025年3月12日最近更新: 2025年4月22日

适应症

试验速览

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•Age >= 18 years.
•Body mass index >= 30 kg/m2 or >= 27 kg/m2 to < 30 kg/m2 with at least 1 of the following weight-related comorbidities: hypertension, dyslipidemia, history of obstructive sleep apnea, history of cardiovascular disease, history of metabolic dysfunction-associated steatotic liver disease (MASLD) or Metabolic Dysfunction-Associated Steatohepatitis (MASH).
•History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.

•Type 1 or Typ2 diabetes mellitus.
•Obesity induced by other endocrinologic disorders.
•Self-reported change in body weight > 5 kg within 90 days before screening.
•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]

Change From Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72(Baseline and Week 72)
Percent Change From Baseline in Fasting Lipid Parameters at Week 72(Baseline and Week 72)
Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72(Baseline and Week 72)

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