Clinical Trials

Inclusion Criteria: 

• Male or female, age 18 to 75 years old.
• 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).
• 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).
• Fibrosis Stage must be 2 or 3.
• Body mass index (BMI) between 25kg/m^2 and 40 kg/m^2.
• AST> 20 IU/L.
• Type 2 diabetes mellitus or prediabetes.
• For subjects with type 2 diabetes, glycemia must be controlled.
• Females of childbearing potential must practice a highly effective method of contraception throughout the study period and for 1 month after treatment discontinuation.
• Able to understand the nature of the study and to provide signature of the written informed consent.

Exclusion Criteria:

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