Status:
COMPLETED
A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of HEC96719 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis
Lead Sponsor:
Sunshine Lake Pharma Co., Ltd.
Conditions:
Non-Alcoholic Steatohepatitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2023
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT05397379
Start Date
November 15 2021
End Date
September 5 2023
Last Update
February 21 2024
Active Locations (9)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China
2
NanFang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510515
3
Affiliated Hospitol of Guangdong Medical University
Guangzhou, Guangdong, China
4
Union Hospital, TongJi Medical College, HuaZhong University of Science and Technology
Wuhan, Hubei, China