Study to Evaluate the Efficacy and Safety of Combination Therapy of K-877-ER and CSG452 in Participants With Noncirrhotic Nonalcoholic Steatohepatitis (NASH) With Liver Fibrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 77
- 主要终点
- Improvement in disease activity and no worsening of liver fibrosis (Yes/No)
研究概览
简要总结
A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and comply with study procedures and give written informed consent
- •Age ≥18 years
- •NAS ≥4 with a score of at least 1 in each component of the NAS (steatosis, lobular inflammation, and ballooning) at Visit 2 liver biopsy, or a historical liver biopsy performed within 24 weeks of randomization
- •Fibrosis stage of 1 or greater and below 4 on NASH CRN (Clinical Research Network) fibrosis staging system at Visit 2 liver biopsy, or a historical liver biopsy performed within 24 weeks of randomization
- •Meet all inclusion criteria outlined in clinical study protocol
排除标准
- •Participation in another clinical trial involving an investigational agent within 30 days prior to signing the Informed Consent Form (ICF) for this study
- •Ongoing or recent consumption of Greater than moderate amounts of alcohol as defined in clinical study protocol
- •Evidence of other forms of chronic liver disease as defined in clinical study protocol
- •Does not meet any other exclusion criteria outlined in clinical study protocol
研究组 & 干预措施
K-877-ER
K-877-ER and CSG452 Placebo QD
干预措施: Placebo (Drug)
CSG452
CSG452 and K-877-ER Placebo QD
干预措施: Placebo (Drug)
Placebo
干预措施: Placebo (Drug)
K-001
K-877-ER and CSG452 Once daily (QD)
干预措施: CSG452 (Drug)
K-001
K-877-ER and CSG452 Once daily (QD)
干预措施: K-877-ER (Drug)
K-877-ER
K-877-ER and CSG452 Placebo QD
干预措施: K-877-ER (Drug)
CSG452
CSG452 and K-877-ER Placebo QD
干预措施: CSG452 (Drug)
结局指标
主要结局
Improvement in disease activity and no worsening of liver fibrosis (Yes/No)
时间窗: Baseline to Week 48
The improvement in disease activity is defined as decrease in NAFLD Activity Score (NAS) ≥2 points. The worsening of fibrosis is defined as any numerical increase in the stage.
次要结局
- Number of Participants With Treatment-Related Adverse Events (AE)(52 Weeks)