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

Inclusion Criteria:

1. An informed consent document must be signed and dated by the subject
2. Male or female, 18 to 65 years of age
3. Body mass index (BMI)≥18.0 and≤35.0 kg/m2, and Weight≥40 kg;
4. Presumed NASH based on clinical characteristics or prior liver biopsy
5. MRI PDFF liver fat content ≥ 10 %

Exclusion Criteria:

previous diagnosis of other forms of chronic liver disease

Laboratory Screening Results:

1. AST > 5 x ULN
2. ALP > 3 x ULN
3. Total bilirubin > 1.5 x ULN
4. Albumin < 3.2 g/dL
5. INR > 1.3
6. Platelet count < 100,000 /mm3
7. creatinine clearance <60 ml/min (based on Cockroft Gault method)
8. previous exposure to OCA
9. uncontrolled diabetes mellitus
10. presence of cirrhosis
11. patients with contraindications to MRI imaging