NCT03976401已完成2 期
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects 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
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Main: Absolute Change From Baseline in Hepatic Fat Fraction Assessed by MRI-PDFF at Week 12.
研究概览
简要总结
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study administered for 16 weeks in subjects with biopsy proven F1 - F4 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
- •Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.
- •Main Study only: Body mass index (BMI) > 25 kg/m^2 (unless the patient has biopsy-proven NASH documented within the last 2 years).
- •Main Study only: Must have confirmation of ≥ 10% liver fat content on magnetic resonance imaging- proton density fat fraction (MRI-PDFF) at screening.
- •Main Study only: Biopsy-proven NASH. Must have had a liver biopsy within 180 days of randomization with fibrosis stage 1 to 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:
- •Steatosis (scored 0 to 3),
- •Ballooning degeneration (scored 0 to 2), and
- •Lobular inflammation (scored 0 to 3)
- •Cohort C only: FibroScan® measurement > 13.1 kPa.
- •Cohort C only: Cirrhosis due to NASH. Liver biopsy consistent with F4 fibrosis according to the NAS system, confirmed by the central or local reader.
排除标准
- •Weight gain or loss > 5% in the 3 months prior to randomization or > 10% in the 6 months prior to screening.
- •Type 1 and insulin-dependent Type 2 diabetes.
- •Poorly controlled hypertension (blood pressure > 160/100).
研究组 & 干预措施
EFX Dose 1
Experimental
Main Study
干预措施: EFX (Drug)
EFX Dose 2
Experimental
Main Study
干预措施: EFX (Drug)
EFX Dose 3
Experimental
Main Study
干预措施: EFX (Drug)
Placebo
Placebo Comparator
Main Study
干预措施: Placebo (Drug)
EFX Dose (Cohort C)
Experimental
干预措施: EFX (Drug)
Placebo (Cohort C)
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Main: Absolute Change From Baseline in Hepatic Fat Fraction Assessed by MRI-PDFF at Week 12.
时间窗: 12 weeks
Main study. ANCOVA multiple imputation with treatment group and F1 fibrosis score (F1 vs F2-3) as factors and baseline hepatic fat fraction measured by MRI-PDFF as a covariate.
次要结局
- Main: Absolute Change From Baseline in Hepatic Fat Fraction Assessed by MRI-PDFF at Week 22-24.(22-24 weeks)
- Main: Responder Based on NAFLD Activity Score System (NAS): Subjects Who Had a Decrease of ≥2 Points in NAS With at Least a 1-point Reduction in Either Lobular Inflammation or Hepatocellular Ballooning and With no Concurrent Worsening of Fibrosis Stage.(22-24 weeks)
- Main: Responder: Subjects Who Achieved a Clinically Meaningful Relative Reduction of at Least 30% in Liver Fat Content as Measured by MRI-PDFF at Week 12.(12 weeks)
- Cohort C: Change From Baseline in Liver Stiffness as Evaluated by FibroScan at Week 16(16 weeks)
- Main: Percent Change From Baseline in Hepatic Fat Fraction Measured by MRI-PDFF at Week 12.(12 weeks)
- Cohort C: Change From Baseline in Non-invasive Biomarkers Including Liver Fibrosis by ELF Test Score at Week 12 and 16.(12 and 16 weeks)
- Main: Percent Change From Baseline in Hepatic Fat Fraction Measured by MRI-PDFF at Week 22-24.(22-24 weeks)
- Main: Change From Baseline in ALT at Week 12, 16, and 20.(12, 16, and 20 weeks)
- Cohort C: Change From Baseline in Non-invasive Biomarkers Including Pro-C3 at Week 12, 16, and 20.(12, 16, and 20 weeks)
研究者
研究点 (1)
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