NCT05118360撤回2 期
A Seamless Phase 2a/2b, Double-Blind, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41, a Thyroid Hormone Receptor β Agonist, in Adults With Nonalcoholic Steatohepatitis (NASH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Percent of ASC41 subjects compared to placebo with histological reduction in NAS ≥2 points that results from reduction of inflammation or ballooning and no worsening fibrosis assessed by histopathological reading of liver biopsy at Week 52
研究概览
简要总结
This is a phase 2, randomized, double-blind, placebo controlled study in adults with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of ASC41 in adults with NASH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Presence of ≥ 8% liver fat content on screening MRI-PDFF.
- •Histologic evidence of NASH upon central read of a liver biopsy obtained no more than 6 months before Day 1 defined by NASH activity score (NAS) greater than or equal to 4 with at least 1 point each in inflammation and ballooning.
- •Diabetes Mellitus well controlled based on laboratory test HbA1c ≤ 9.5%.
排除标准
- •Evidence of advanced liver disease such as cirrhosis (stage 4 fibrosis) or decompensated liver disease (e.g. ascites, esophageal varices) or liver cancer.
- •Evidence of other causes of chronic liver disease.
- •Weight change ≥ 5% after qualifying liver biopsy or MRI-PDFF performed.
- •Any contraindications to a MRI scan.
- •Treatment with vitamin E (unless stable dose of < 400 IU/d), thiazolidinediones (TZD), or glucagon-like peptide-1 receptor agonists (GLP-1 RA), unless subject is on a stable dose for 6 months prior to qualifying liver biopsy.
- •Known history of alcohol or other substance abuse within the last year or at any time during the study.
- •Use of any investigational drug within 6 months of MRI-PDFF and/or liver biopsy.
- •Known positivity for antibody to Human Immunodeficiency Virus (HIV).
研究组 & 干预措施
Part 1-ASC41 2mg
Experimental
ASC41 2mg for 52 weeks.
干预措施: ASC41 2 mg (Drug)
Part1-placebo
Placebo Comparator
Matching placebo for 52 weeks.
干预措施: Placebo (Drug)
Part 2-ASC41 4mg
Experimental
ASC41 4 mg for 52 weeks.
干预措施: ASC41 4 mg (Drug)
Part2-placebo
Placebo Comparator
Matching placebo for 52 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent of ASC41 subjects compared to placebo with histological reduction in NAS ≥2 points that results from reduction of inflammation or ballooning and no worsening fibrosis assessed by histopathological reading of liver biopsy at Week 52
时间窗: Baseline to Week 52
次要结局
- Change in hepatic fat fraction based on MRI-PDFF measurements in ASC41 treated subjects compared to placebo.(Baseline to Week 12 and Week 52)
- Resolution of NASH on overall histopathological reading of liver biopsy specimen taken at Week 52 compared to baseline in ASC41 treated subjects compared to placebo treated subjects(Baseline to Week 52)
- Safety and tolerability of ASC41 evaluated by incidence of treatment emergent adverse events (TEAEs) in ASC41 treated subjects compared to placebo(Baseline to Week 52)
研究者
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