NCT04767529已完成2 期
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Non-Cirrhotic Subjects With Nonalcoholic Steatohepatitis (NASH)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Effect of Efruxifermin (EFX) vs Placebo on Fibrosis Regression in Participants With Metabolic Dysfunction-associated Steatohepatitis (MASH)-Associated Stage 2 or 3 Fibrosis (F2 or F3)
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 in non-cirrhotic subjects with biopsy-proven F2 - F3 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 75 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 - 75 years of age inclusive, based on the date of the screening visit.
- •Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.
- •FibroScan measurement > 8.5 kPa [kilopascal].
- •Biopsy-proven NASH. Must have had a liver biopsy obtained ≤ 180 days prior to randomization with fibrosis stage 2 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).
排除标准
- •Weight loss > 5% in the 3 months prior to screening until randomization or from the time of the diagnostic liver biopsy until randomization, whichever is longer.
- •Presence of cirrhosis on liver biopsy (stage 4 fibrosis).
- •Type 1 or uncontrolled Type 2 diabetes.
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
placebo
Placebo Comparator
double-blind, once-weekly subcutaneous injection
干预措施: Placebo (Drug)
Efruxifermin 28 mg
Experimental
double-blind, once-weekly subcutaneous injection
干预措施: Efruxifermin (Drug)
Efruxifermin 50 mg
Placebo Comparator
double-blind, once-weekly subcutaneous injection
干预措施: Efruxifermin (Drug)
结局指标
主要结局
Effect of Efruxifermin (EFX) vs Placebo on Fibrosis Regression in Participants With Metabolic Dysfunction-associated Steatohepatitis (MASH)-Associated Stage 2 or 3 Fibrosis (F2 or F3)
时间窗: 24 Weeks
Proportions of subjects in EFX vs placebo groups with improvement in liver fibrosis, defined as ≥ 1 stage NASH Clinical Research Network \[CRN\] fibrosis score (score ranges from 0 to 4, increasing with fibrosis severity), and no worsening of steatohepatitis (no increase in NASH Activity Score \[NAS\], which ranges from 0 to 8 and is the sum of scores of steatosis, lobular inflammation, and hepatocyte ballooning), at Week 24
次要结局
- Change From Baseline in C-peptide at Week 24 and Week 96(24 Weeks, 96 Weeks)
- Change From Baseline in Adiponectin at Week 24 and Week 96(24 Weeks, 96 Weeks)
- Proportion of Subjects Who Achieve Improvement in Liver Fibrosis ≥ 1 Stage and no Worsening of Steatohepatitis at Week 96(96 Weeks)
- Proportion of Subjects Who Achieve Resolution of Steatohepatitis and no Worsening of Liver Fibrosis at Week 24 and Week 96(24 and 96 weeks)
- Proportion of Subjects Who Achieve Improvement in Liver Fibrosis ≥ 1 Stage at Week 24 and Week 96(24 and 96 Weeks)
- Change From Baseline in Hepatic Fat Fraction in EFX vs Placebo Groups(24 and 96 Weeks)
- Change From Baseline in Lipoproteins at Week 24 and Week 96(24 and 96 weeks)
- Change From Baseline of Hemoglobin A1c (Glycated Hemoglobin, HbA1c) at Week 24 and Week 96(24 Weeks, 96 Weeks)
- Change From Baseline in Collagen III Neo-Peptide (C3M) at Week 24 and Week 96(24 and 96 Weeks)
- Change From Baseline in NIS4 Score at Week 24 and Week 96(24 and 96 Weeks)
- Change in Body Weight at Week 24 and Week 96(24 and 96 weeks)
- Change From Baseline in Liver Stiffness (kPa) at Week 24 and Week 96(24 and 96 weeks)
- Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Week 24 and Week 96(24 Weeks, 96 Weeks)
- Change From Baseline in Enhanced Liver Fibrosis (ELF) Score at Week 24 and Week 96(24 and 96 Weeks)
- Change From Baseline in N-terminal Type III Collagen Propeptide (Pro-C3) at Week 24 and Week 96(24 and 96 Weeks)
研究者
研究点 (1)
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