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

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Orally Administered HEC96719 Tablets in Adult Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis

This is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics of HEC96719 in non-cirrhotic NASH patients.

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