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.

Study Overview

• Status: Completed
• Conditions: Non-Alcoholic Steatohepatitis
• Intervention / Treatment: Drug: HEC96719; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking University People's Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital of Southern Medical University
    • Guangzhou, Guangdong, China
      • Affiliated Hospitol of Guangdong Medical University
  • Hubei
    • Wuhan, Hubei, China
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • Hunan Provincial People's Hospital
  • Jilin
    • Changchun, Jilin, China
      • The First Hospital of Jilin University
  • Shanxi
    • Xi'an, Shanxi, China
      • The First Affiliated Hospitol of Xi'an Jiaotong University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The First Affiliated Hospital, Zhejiang University School of Medicine
    • Wenzhou, Zhejiang, China
      • The First Affiliated Hospitol of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HEC96719 0.25 mg; Oral dose once daily for 12 weeks	Drug: HEC96719; Oral tablets
Experimental: HEC96719 0.35 mg; Oral dose once daily for 12 weeks	Drug: HEC96719; Oral tablets
Experimental: HEC96719 0.5 mg; Oral dose once daily for 12 weeks	Drug: HEC96719; Oral tablets
Experimental: HEC96719 0.25 mg bid; Oral dose twice daily for 12 weeks	Drug: HEC96719; Oral tablets
Placebo Comparator: Placebo; Oral dose once or twice daily for 12 weeks	Drug: Placebo; Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 - AUC	Area under the curve	4 weeks
Plasma concentration of HEC96719 - Cmax	Maximum observed concentration	4 weeks
Plasma concentration of HEC96719 - Tmax	Time to reach maximum measured plasma concentration	4 weeks
Plasma concentration of HEC96719 - t1/2	Determination of half-life	4 weeks

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.
• Investigators: Study Chair: Jinlin Hou, Doctor, Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): September 5, 2023
• Study Completion (Actual): September 5, 2023

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: HEC96719-NASH-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No