Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 5 years prior to screening
Clinical or histological evidence of cirrhosis
Evidence of other forms of chronic liver disease:
Serum alanine aminotransferase (ALT) greater than 300 U/L
Fasting plasma glucose of 126 mg/dL or greater
Serum creatinine of 2.0 mg/dL or greater
Use of drugs historically associated with NAFLD for more than 2 consecutive weeks in the 2 years prior to screening
Use of antidiabetic drugs in the 3 months prior to liver biopsy or the 3 months prior to randomization
Use of antiNASH drugs (thiazolidinediones,vitamin E, metformin, UDCA, SAM-e, betaine, milk thistle, gemfibrozil, anti-TNF therapies, probiotics) in the 3 months prior to liver biopsy or the 3 months prior to randomization
Use of a non-stable dose of statins or fibrates in the 3 months prior to biopsy or the 3 months prior to randomization
Known intolerance to thiazolidinediones or vitamin E
Vitamin E supplementation of greater than 100 IU/day
Inability to safely obtain a liver biopsy
History of diabetes mellitus
History of total parenteral nutrition in the year prior to screening
History of bariatric surgery (jejunoileal bypass or gastric weight loss surgery) or currently undergoing evaluation for bariatric surgery
History of biliary diversion
Known positivity for antibody to Human Immunodeficiency Virus
Known heart failure of New York Heart Association class 2, 3, or 4
Active, serious medical disease with likely life-expectancy less than 5 years
Active substance abuse, such as alcohol or inhaled or injection drugs, in the year prior to screening
Women of childbearing potential: positive pregnancy test during screening or at randomization or unwillingness to use an effective form of birth control during the trial
Women: Breast feeding
Any other condition which, in the opinion of the investigator would impede compliance or hinder completion of the study
Failure to give informed consent
