KCT0005256招募中未知
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2a Study to Explore the Safety and Efficacy of ALS-L1023 in Patients With Non-alcoholic Steatohepatitis (NASH)
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- AngioLab
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •Men or women ages 19 and over, under 75 years of age
- •Patients diagnosed with NAFLD on abdominal ultrasonography and MRI
- •Patients show presence of hepatic fat fraction as defined by = 8% on MRI-PDFF and liver stiffness as defined by = 2.5 kPa on MRE at Screening
排除标准
- •1. Any subject with current, significant alcohol consumption or a history of significant alcohol consumption for a period of more than 3 consecutive months any time within 2 year prior to screening will be excluded
- •2. Any subject with current liver disease or history of liver disease
- •- acute and chronic viral hepatitis
- •- liver cancer
- •- autoimmune liver disease
- •- alcoholic liver disease
- •3. Type 1 diabetes or uncontrolled diabetes mellitus as defined by a HbA1c = 9.0% at Screening
- •4. Pregnant or lactating women
研究者
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