JPRN-jRCT2031230187招募中2 期
A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults With Precirrhotic Nonalcoholic Steatohepatitis
Tanaka Yoshiyuki0 个研究点目标入组 30 人开始时间: 2023年6月28日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •1)Histological confirmation of NASH, defined as NAFLD Activity Score (NAS) =>4 with a score =>1 point in each component (steatosis, ballooning, and lobular inflammation) AND NASH clinical research network (CRN) fibrosis score of Stage 2 or 3
- •2)No history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM with an A1C <=9% that is controlled by diet or stable doses of antihyperglycemic agents (AHAs)
- •3)Participants in South Korea are eligible between the ages of 19 to 80 years of age (inclusive)
排除标准
- •1)History of liver disease other than NASH
- •2)History or evidence of cirrhosis
- •3)History of pancreatitis
- •4)History of Type 1 diabetes mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatectomy
- •5)History of a bariatric surgical procedure <=5 years before study entry, or a known clinically significant gastric emptying abnormality
- •6)Major illnesses less than 6 months before starting the study.
研究者
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