Could a statin tame fatty liver disease? new trial seeks answers

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 \< 1.0 x 109/L, c) Platelets \< 100 109/L, d) Hemoglobin \< 10 g/dl, e) Albumin \< 3.5 g, f) Prolonged international normalized ratio (INR), g) Any elevation of bilirubin above normal (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction), h) Serum creatinine \> 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.