A Phase 2a, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Enyo Pharma
- 入组人数
- 120
- 试验地点
- 42
- 主要终点
- Analysis of Absolute Change From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
研究概览
简要总结
The purpose of this study is to assess the effects of EYP001a (Vonafexor) with respect to safety, tolerability, pharmacokinetics and on markers of liver inflammation in patients with NASH
详细描述
This is a 2-part, randomized, double-blind, multicenter, placebo-controlled study to evaluate the safety and efficacy of Vonafexor in patients with NASH who likely have stage F2 to F3 fibrosis at approximately 50 global clinical sites. Overall, approximately 114 eligible patients will be enrolled: 24 patients in Part A (Safety Run-in Cohort), followed by 90 patients in Part B.
In Part A, 24 patients will be randomized on Day 1 to 1 of 4 parallel treatment groups: 100 mg Vonafexor twice daily (BID), 200 mg Vonafexor once daily (QD), 400 mg Vonafexor QD, or placebo BID. In Part B, 90 patients will be randomized on Day 1 to 1 of 3 parallel treatment groups: 100 mg Vonafexor QD, 200 mg Vonafexor QD, or placebo QD.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Suspected diagnosis of NASH, evidenced by elevated alanine aminotransferase (ALT), liver stiffness compatible with F2 or F3 fibrosis and Liver Fat Content (LFC) ≥10% as measured by MRI
- •Women of childbearing potential and male patients with female partners must agree to use a dual method of contraception
排除标准
- •Evidence of worsening liver injury
- •Previous diagnosis of other forms of non-NASH liver disease
- •Use of Vitamin E, glitazones, glucagon-like Peptide-1 receptor agonists, ursodeoxycholic acid, or obeticholic acid within 90 days prior to screening
- •History of cirrhosis or liver decompensation
- •Known history of alcohol abuse or daily heavy alcohol consumption
- •Pregnant or breastfeeding women
- •Type 1 diabetes mellitus and uncontrolled type 2 diabetes mellitus
- •Patients with contraindications to MRI imaging
研究组 & 干预措施
Vonafexor 100 mg BID
Oral dose twice daily for 12 weeks (84 days)
干预措施: Vonafexor (Drug)
Vonafexor 200 mg QD
Oral dose once daily for 12 weeks (84 days)
干预措施: Vonafexor (Drug)
Vonafexor 400 mg QD
Oral dose once daily for 12 weeks (84 days)
干预措施: Vonafexor (Drug)
Placebo
Oral dose twice daily for 12 weeks (84 days)
干预措施: Placebo (Other)
Vonafexor 100 mg QD
Oral dose once daily for 12 weeks (84 days)
干预措施: Vonafexor (Drug)
结局指标
主要结局
Analysis of Absolute Change From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
时间窗: 12 weeks
The liver fat percentage was assessed by MRI-PDFF, which is an established method that enables the quantification of fat content in the liver; the value of liver fat is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level.
次要结局
- Analysis of Change From Baseline in Body Weight(12 weeks)
- Analysis of Change From Baseline in Glomerular Filtration rate_Part B(12 weeks)
- Analysis of Change From Baseline in Corrected T1 (CT1)(12 weeks)
- Analysis of Percent Change (Relative) From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)(12 weeks)
- Analysis of Change From Baseline in Gamma Glutamyltranspeptidase (GT)(12 weeks)
- Analysis of Change From Baseline in Waist Circumference(12 weeks)
- Analysis of Change From Baseline in Glomerular Filtration rate_Part A(12 weeks)
- Analysis of Change From Baseline in Alanine Aminotransferase (ALT)(12 weeks)
- Analysis of Change From Baseline in Waist to Hip ratio_Part B(12 weeks)