A Phase II, Double-Blind, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Subjects With Nonalcoholic Steatohepatitis (NASH)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- To evaluate the effect of ASC41 compared with placebo in noncirrhotic subjects with NASH by a histological change.
研究概览
简要总结
This is a Phase 2, Double-Blind, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults with Nonalcoholic Steatohepatitis (NASH).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 80 years old at screening.
- •Presence of ≥ 7.5% steatosis on screening MRI-PDFF read centrally by a radiologist and performed either during the screening period or within 6 months prior to the first visit.
- •HbA1c ≤ 9.5%.
- •Normal or minimally abnormal renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m^2
排除标准
- •Presence or history of cirrhosis or evidence of decompensated liver disease (e.g., ascites, variceal bleeding) or hepatocellular carcinoma.
- •History or presence of other concomitant liver disease as assessed by the investigator or determined by laboratory findings.
- •Uncontrolled Type 2 diabetes mellitus (T2DM) defined as HbA1c of > 9.5% within 60 days prior to enrollment.
- •Change in anti-diabetic therapy within 6 months prior to qualifying liver biopsy.
研究组 & 干预措施
Cohort 1 Low Dose
1 tablet of ASC41 (2 mg) for 52 weeks
干预措施: 2mg of ASC41 (Drug)
Cohort 1 Low Dose
1 tablet of ASC41 (2 mg) for 52 weeks
干预措施: Placebo (Drug)
Cohort 2 High Dose
2 tablet of ASC41 (4 mg) for 52 weeks
干预措施: 4mg of ASC41 (2 tablets of 2 mg ASC41) (Drug)
Placebo tablet
Placebo tablet for 52 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the effect of ASC41 compared with placebo in noncirrhotic subjects with NASH by a histological change.
时间窗: Baseline and Week 52
A histological change in NAFLD (nonalcoholic fatty liver disease) Activity Score (NAS) ≥ 2 points that results from reduction of necroinflammation (inflammation or ballooning) without worsening fibrosis. (The NAFLD Activity Score including steatosis, inflammation and ballooning. The maximum score of steatosis was 3 and the minimum score was 0, the maximum score of inflammation was 3 and the minimum score was 0, and the maximum score of ballooning was 2 and the minimum score was 0. The higher scores mean a worse outcome. ）
次要结局
- The incidence, type and severity of AEs/SAEs were assessed by CTCAE v5.0 to assess the safety and tolerability of ASC41 compared to placebo(24 and 52 weeks)
- Plasma pharmacokinetics - Area under the plasma drug concentration versus time curve( AUC0-t_, AUC0-∞)(1 and 15 Days)
- Plasma pharmacokinetics - The amount of time that a drug is present at the maximum concentration in serum(Tmax)(1 and 15 Days)
- Change from baseline in hepatic fat fraction assessed by MRI-PDFF(24 and 52 weeks)
- To evaluate the effect of ASC41 compared with placebo on serum lipids (cholesterol, HDL-C, LDL-C, triglycerides, Lp(a), VLDL)(12, 24 and 52 weeks)
- Plasma pharmacokinetics - Peak Plasma Concentration (Cmax)(1 and 15 Days)