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
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in serum concentrations of ALT and AST
研究概览
简要总结
The main objective of this study is to evaluate safety and efficacy of ALS-L1023 in patients with Non-alcoholic steatohepatitis
详细描述
Besides the main objectives, there are other objectives as follows:
- To evaluate efficacy of ALS-L1023 for liver fibrosis and steatosis by noninvasive imaging biomarker MRI-PDFF and MRE
- To determine optimized dose of ALS-L1023 in NASH disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •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
- •Chronic liver disease (including hemochromatosis, liver cancer, autoimmune liver disease, viral hepatitis A, B, alcoholic liver disease
- •Uncontrolled diabetes mellitus as defined by a HbA1c ≥ 9.0％ at Screening
- •Patients who are allergic or hypersensitive to the drug or its constituents
- •Pregnant or lactating women
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo oral tablet (Drug)
ALS-L1023 1,200mg
ALS-L1023 600mg twice a day
干预措施: ALS-L1023 1,200mg (Drug)
ALS-L1023 1,800mg
ALS-L1023 900mg twice a day
干预措施: ALS-L1023 1,800mg (Drug)
结局指标
主要结局
Changes in serum concentrations of ALT and AST
时间窗: baseline, 24weeks
ALT and AST concentrations in serum are measured
Change in liver fat percentage measured by MRI-PDFF
时间窗: baseline, 24 weeks
Liver fat is measured by MRI-PDFF
Change in liver fibrosis measured by MRE
时间窗: baseline, 24 weeks
Liver fibrosis is measured by Magnetic Resonance Enterography
Change in visceral fat area measured by MRI
时间窗: baseline, 24weeks
Visceral fat area is measured by MRI
次要结局
- Change in serum concentration of CK-18(baseline, 24weeks)
- Changes in serum concentrations of ALT and AST(baseline, 8weeks, 16weeks)
- Change in serum concentration of Adiponection(baseline, 24weeks)
- Change in serum concentration of Leptin(baseline, 24weeks)
- Changes in serum concentrations of TG and TC(baseline, 8weeks, 16weeks, 24weeks)
- Change in serum concentration of Pro-C3(baseline, 24weeks)
- Change in insulin sensitivity determined by HOMA-IR(baseline, 24weeks)
- Change of NAFLD fibrosis score(NFS)(baseline, 8weeks, 16weeks, 24weeks)
- Change in serum concentration of Ghrelin(baseline, 24weeks)