Statins for the Treatment of NASH

Inclusion Criteria:

• Definite NASH on a liver biopsy obtained ≤ 90 days prior to randomization with aNAFLD activity score (NAS) of ≥ 4 with at least 1 in each component of the NASaccording 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 bearingpotential.

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 RNApositive.

• Receiving an elemental diet or parenteral nutrition

• Chronic pancreatitis or pancreatic insufficiency

• Any history of complications of cirrhosis (i.e. ascites, hepatic encephalopathy, orportal hypertensive bleeding), even if absent or optimized with medical managementat time of screening

• Concurrent conditions: a) Inflammatory bowel disease, b) Unstable angina, myocardialinfarction, transient ischemic events, or stroke within 24 weeks of screening, c)Ongoing infectious, immune mediated disease within previously 1 years, d) Anymalignant disease (other than basal cell carcinoma of the skin) within previous 5years, e) Prior solid organ transplant, f) Any other concurrent condition which, inthe opinion of the investigator, could impact adversely on the subject participatingor the interpretation of the study data.

• Concurrent medications including: a) Anti-NASH therapy(s) initiated after the liverbiopsy diagnosing NASH. Anti-NASH therapies include S-adenosyl methionine (SAMe),milk thistle, and vitamin E at dose of ≥ 400 IU/day; b) Antidiabetic mediation whichmay 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 < 10g/dl, e) Albumin < 3.5 g, f) Prolonged international normalized ratio (INR), g) Anyelevation of bilirubin above normal (unless Gilbert's syndrome or extrahepaticsource as denoted by increased indirect bilirubin fraction), h) Serum creatinine > 1.5 mg/dl, i) Creatinine clearance ≤ 50 ml/minute calculated by Crockroft-Gault orcreatinine > 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) forthe 48-week duration of the trial and for 1 month after the first administration ofthe drug.

• Participation in an investigational drug study within past 3 months.