CTIS2022-502647-35-00招募中1 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 - MK-6024-013
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 316
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •Histologic confirmation of NASH based on liver biopsy. Histologic criteria for study entry include: •Nonalcoholic fatty liver disease (NAFLD) Activity Score =4 with a score =1 point in each component (steatosis, ballooning, and lobular inflammation), AND •NASH Clinical Research Network (CRN) fibrosis score indicative of Stage 2 or 3., No history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM controlled by diet or stable doses of antihyperglycemic agents (AHAs), Participants in South Korea are eligible between the ages of 19 to 80 years of age (inclusive)
排除标准
- •History of liver disease other than NASH, History or evidence of cirrhosis, History of pancreatitis, History of Type 1 Diabetes Mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatectomy, History of bariatric surgery =5 years before study participation, Has significant systemic or major illnesses, including recent events (=6 months before study entry) of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack
研究者
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