New drug aramchol aims to reverse fatty liver damage in phase 3 trial

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

Key Inclusion Criteria: 1. Male or female age 18 to 75 years 2. Histological confirmation of NASH on a diagnostic liver biopsy by central reading of the slides (biopsy obtained within 6 months prior to randomization or during the screening period) 3. Total NAS Score 4 or more with at least 1 in each component of the NAS Score (steatosis ≥1 AND inflammation ≥1 AND ballooning ≥1) 4. Fibrosis Stage must be 2 or 3 (Open-Label Part may include up to 30 subjects with fibrosis stage 1) 5. Body mass index (BMI) between 25kg/m2 and 40 kg/m2 (Open Label part: BMI \<40 kg/m2) 6. AST\>20 IU/L 7. Type 2 diabetes mellitus or prediabetes (Open Label Part only: Type 2 diabetes or prediabetes is not an inclusion criteria) 8. For subjects with type 2 diabetes, glycemia must be controlled 9. Females of childbearing potential must practice a highly effective method of contraception throughout the study period and for 1 month after treatment discontinuation. 10. Able to understand the nature of the study and to provide signature of the written informed consent. Key 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