Clinical Trials/NCT05397379

NCT05397379

Completed

Phase 2

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

Sunshine Lake Pharma Co., Ltd.9 sites in 1 country68 target enrollmentNovember 15, 2021

ConditionsNon-Alcoholic Steatohepatitis

InterventionsHEC96719 Placebo

DrugsHEC96719 Placebo

Overview

Phase: Phase 2
Intervention: HEC96719
Conditions: Non-Alcoholic Steatohepatitis
Sponsor: Sunshine Lake Pharma Co., Ltd.
Enrollment: 68
Locations: 9
Primary Endpoint: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 15, 2021

End Date

September 5, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sunshine Lake Pharma Co., Ltd.

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

HEC96719 0.25 mg bid

Oral dose twice daily for 12 weeks

Intervention: HEC96719

HEC96719 0.25 mg

Oral dose once daily for 12 weeks

Intervention: HEC96719

HEC96719 0.35 mg

Oral dose once daily for 12 weeks

Intervention: HEC96719

HEC96719 0.5 mg

Oral dose once daily for 12 weeks

Intervention: HEC96719

Placebo

Oral dose once or twice daily for 12 weeks

Intervention: Placebo

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time Frame: 12 weeks

Secondary Outcomes

Mean Change From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 12(Baseline and Week 12)
Plasma concentration of HEC96719 - t1/2(4 weeks)
Plasma concentration of HEC96719 - Tmax(4 weeks)
Plasma concentration of HEC96719 - AUC(4 weeks)
Plasma concentration of HEC96719 - Cmax(4 weeks)