A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of HEC96719 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis

Inclusion Criteria: * An informed consent document must be signed and dated by the subject * Male or female, 18 to 65 years of age * Body mass index (BMI)≥18.0 and≤35.0 kg/m2, and Weight≥40 kg; * Presumed NASH based on clinical characteristics or prior liver biopsy * MRI PDFF liver fat content ≥ 10 % Exclusion Criteria: * previous diagnosis of other forms of chronic liver disease * Laboratory Screening Results: * AST \> 5 x ULN * ALP \> 3 x ULN * Total bilirubin \> 1.5 x ULN * Albumin \< 3.2 g/dL * INR \> 1.3 * Platelet count \< 100,000 /mm3 * creatinine clearance \<60 ml/min (based on Cockroft Gault method) * previous exposure to OCA * uncontrolled diabetes mellitus * presence of cirrhosis * patients with contraindications to MRI imaging