A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR)

Exclusion Criteria

• •1. Histologically documented liver cirrhosis (fibrosis stage 4)
• •2. Inability or unwillingness to undergo a liver biopsy
• •3. Abnormal synthetic liver function
• •4. ALT or AST \>5× upper limit of normal (ULN)
• •5. Platelet count \< 150,000mm3
• •6. Alkaline phosphatase ≥2× ULN
• •7. Known or suspected hepatocellular carcinoma (HCC)
• •8. Model for End-Stage Liver Disease (MELD) score \> 12
• •9. Prior history or presence of decompensated liver disease
• •10. Other (acute or chronic) coexisting liver disease based on medical history and/or centralized review of liver histology)
• •11. Known alcohol and/or any other drug abuse or dependence in the last five years
• •12. Weight loss of more than 5% within 3 months prior to screening
• •13. History of bariatric surgery within 5 years of liver biopsy or planned surgery for weight reduction
• •14. Treatment with drugs that may cause NAFLD within 12 months prior to liver biopsy
• •15. Treatment with some anti-diabetic medications; Unless started prior to biopsy (timeframe depending on drug) and stable
• •16. Current or planned treatment with immunosuppressive drugs
• •17. Evidence of any other unstable or untreated clinically significant disease
• •18. Uncontrolled hypertension
• •19. Any other condition that in the opinion of the Investigator warrants exclusion from the study