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

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Criteria

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