Silymarin for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)

Inclusion Criteria: * Male or female 18 years of age or older. * Diagnosed with NASH (refer to Section 5.2) * AST and/or ALT greater than 40 IU/L. * Must agree to adhere to alcohol consumption guideline. * Weight gain//loss of no more than 10% between biopsy and screening or within 30 days of screening if the biopsy is performed during the screening period. * No change in diabetic and/or lipid medications between biopsy and screening or within 30 days of screening if the biopsy is performed during the screening period Exclusion Criteria: * Use of silymarin or other milk thistle preparations for a period of 90 consecutive days or longer between biopsy and initial screening, or within 30 days prior to screening if the biopsy is performed during the screening period. * Use of other antioxidants or non-prescribed complementary alternative medications for a period of 90 consecutive days or longer between biopsy and initial screening, or within 30 days prior to screening if the biopsy is performed during the screening period. * Use of warfarin, metronidazole, or acetaminophen (greater than 2 grams per day) between screening and randomization. * Use of oral steroids for more than 14 days of screening or prior to randomization. * BMI ≥ 35 kg/m2 between screening and randomization. * Poorly-controlled diabetes (HbA1c \> 8 %) between screening and randomization * Diabetes mellitus treated with oral agents other than the secretagogues or metformin between screening and randomization. Sitagliptin is allowed. * For patients using anti-hyperlipidemic agents or accepted anti-diabetic agents, any change of agent or dose between screening and randomization. * Radiologic imaging consistent with cirrhosis or portal hypertension. * Evidence of decompensated liver disease * Platelet count \< 130 x 109 /L at screening. * History of bariatric surgery, or undergoing evaluation for bariatric surgery. * Known allergy/sensitivity to milk thistle or its preparations. * History of immunologically mediated disease * History of thyroid disease poorly controlled on prescribed medications. * History of solid organ or bone marrow transplantation. * Primary hepatic malignancy. * Secondary hepatic malignancy or extrahepatic malignancy. * Serum Creatinine of 176 μmol/L or greater or creatinine clearance (calculated according to Cockcroft-Gault) 60 mL/min or less, or on dialysis, at screening. * Severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study. * Women with ongoing pregnancy or breast feeding, or contemplating pregnancy. * Women of childbearing potential who are not practicing an acceptable form of birth control. * Participation in a research drug trial within 30 days of screening. * Inability or unwillingness to give informed consent or abide by the study protocol.