statins for the treatment of nash

Conditions: NASH - Nonalcoholic Steatohepatitis

Summary: 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.


Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * 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 * hiv antibody positive, hepatitis b surface antigen positive (hbsag), or hcv rna positive. * receiving an elemental diet or parenteral nutrition * chronic pancreatitis or pancreatic insufficiency * any history of complications of cirrhosis (i.e. ascites, hepatic encephalopathy, or portal hypertensive bleeding), even if absent or optimized with medical management at time of screening * concurrent conditions: a) inflammatory bowel disease, b) unstable angina, myocardial infarction, transient ischemic events, or stroke within 24 weeks of screening, c) ongoing infectious, immune mediated disease within previously 1 years, d) any malignant disease (other than basal cell carcinoma of the skin) within previous 5 years, e) prior solid organ transplant, f) any other concurrent condition which, in the opinion of the investigator, could impact adversely on the subject participating or the interpretation of the study data. * concurrent medications including: a) anti-nash therapy(s) initiated after the liver biopsy diagnosing nash. anti-nash therapies include s-adenosyl methionine (same), milk thistle, and vitamin e at dose of ≥ 400 iu/day; b) antidiabetic mediation which may impact nash histology started in the past 12 months including thiazolidinediones (glitazones), dipeptidyl peptidase 4 inhibitors (gliptins) or glucagon-like peptide 1 analogs; c) immune modulatory agents including systemic steroids, methotrexate, anti-tnf-α therapies (infliximab, adalimumab, etanercept) or anti-integrin therapy (namixilab). * self-reported or known marijuana or illicit drug use 30 days before the screening * the following laboratory abnormalities within 90 days of screening: a) hba1c \> 9.0%, b) neutrophil count \ 1.5 mg/dl, i) creatinine clearance ≤ 50 ml/minute calculated by crockroft-gault or creatinine \> 1.5x upper limit of normal * pregnancy or breastfeeding. * women, of childbearing age, who are not willing to practice effective contraception (i.e., barrier, oral contraceptives, or past medical history of hysterectomy) for the 48-week duration of the trial and for 1 month after the first administration of the drug. * participation in an investigational drug study within past 3 months.