A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Statins in Adult Patients With Non-Alcoholic Steatohepatitis (NASH)

Mayo Clinic2 个研究点分布在 1 个国家目标入组 70 人2023年1月25日

适应症NASH - Nonalcoholic Steatohepatitis

干预措施Atorvastatin Placebo

概览

阶段: 2 期
干预措施: Atorvastatin
疾病 / 适应症: NASH - Nonalcoholic Steatohepatitis
发起方: Mayo Clinic
入组人数: 70
试验地点: 2
主要终点: Change in NASH as measured by improvement in NAS score Improvement in NAS score (≥ 2 points) with no worsening in fibrosis stage (≥1 point) OR improvement in fibrosis with no worsening of NASH (change in the NAS score of ≤ 0 points).
状态: 进行中（未招募）
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The purpose of this research study is to determine whether the study drug, atorvastatin (Lipitor®), is safe and effective in improving the features of NASH.

注册库

clinicaltrials.gov

开始日期

2023年1月25日

结束日期

2026年12月1日

最后更新

3个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Mayo Clinic

责任方

Principal Investigator

主要研究者

Manal F. Abdelmalek

Principal Investigator

Mayo Clinic

入排标准

入选标准

•Definite NASH on a liver biopsy obtained ≤ 90 days prior to randomization with a NAFLD activity score (NAS) of ≥ 4 with at least 1 in each component of the NAS according to NASH CRN grading52
•Fibrosis stage ≥ 2 as assessed by liver biopsy
•Not currently on statin therapy
•Provision of written informed consent
•Agree to use of effective contraceptive measures if female of child bearing potential.

排除标准

•The presence of any of the following will exclude a subject from study enrollment: Any chronic liver disease other than NASH (i.e., drug-induced, viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, hemochromatosis, A1AT deficiency, Wilsons disease)
•Cirrhosis, as assessed clinically or histologically
•Presence of vascular liver disease
•BMI ≤ 25 kg/m2
•Excessive alcohol use (\> 20 g/day) within the past 2 years
•AST or ALT \> 250 U/L.
•Type 1 diabetes mellitus
•Bariatric surgery in the past 5 years.
•Weight gain of \> 5% in past 6 months or \> 10% change in past 12 months.
•Inadequate venous access

研究组 & 干预措施

Group 1: Atorvastatin Treatment

Subjects who have a histology-proved NASH with fibrosis stage 2 or higher will receive atorvastatin for 96 weeks

干预措施: Atorvastatin

Group 2: Placebo

Subjects who have a histology-proved NASH with fibrosis stage 2 or higher will receive a placebo for 96 weeks

干预措施: Placebo

结局指标

主要结局

Change in NASH as measured by improvement in NAS score Improvement in NAS score (≥ 2 points) with no worsening in fibrosis stage (≥1 point) OR improvement in fibrosis with no worsening of NASH (change in the NAS score of ≤ 0 points).

时间窗: Baseline, 96 weeks

One overall score of NASH improvement will be derived from improvement in NAS score OR no worsening in fibrosis.

次要结局

NASH resolution as measured by (diagnosis by pathologist) (from definite- to not- NASH).....(Baseline, 96 weeks)
Change in fibrosis stage as measured by change in stage(Baseline, 96 weeks)
Change in each component of NASH histologic features as measured by presence or ab presence or absence of features or their severity.(Baseline, 96 weeks)
Change in serum aminotransferase (ALT) and aspartate aminotransferase (AST) levels as measured by plasma concentrations(Baseline, 96 weeks)
Change in makers of hepatic fibrosis markers as measured by (FIB-4,51 liver stiffness by Fibroscan®)(Baseline, 96 weeks)
Change in capture attention parameter (CAP) score (with Fibroscan®)(Baseline, 96 weeks)
Serum creatine phosphokinase (CPK) as measured by serum concentration(Baseline, 96 weeks)
Change in serum lipids as measured by serum concentration(Baseline, 96 weeks)