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

Phase 2

Completed

• Conditions: Non-Alcoholic Steatohepatitis
• Interventions: Drug: HEC96719; Drug: Placebo

• Registration Number: NCT05397379
• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-15
• Status Verified: 2022-05
• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-05-25
• Study First Posted: 2022-05-31
• Primary Completion: 2023-09-05
• Study Completion: 2023-09-05
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HEC96719 0.25 mg	HEC96719	Oral dose once daily for 12 weeks
Placebo	Placebo	Oral dose once or twice daily for 12 weeks
HEC96719 0.5 mg	HEC96719	Oral dose once daily for 12 weeks
HEC96719 0.35 mg	HEC96719	Oral dose once daily for 12 weeks
HEC96719 0.25 mg bid	HEC96719	Oral dose twice daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	12 weeks

Secondary Outcome Measures

Name	Time	Method
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	Determination of half-life
Plasma concentration of HEC96719 - Tmax	4 weeks	Time to reach maximum measured plasma concentration
Plasma concentration of HEC96719 - AUC	4 weeks	Area under the curve
Plasma concentration of HEC96719 - Cmax	4 weeks	Maximum observed concentration

Trial Locations

Locations (9)

Hunan Provincial People's Hospital; 🇨🇳 Changsha, Hunan, China

NanFang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

Union Hospital, TongJi Medical College, HuaZhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

Affiliated Hospitol of Guangdong Medical University; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospitol of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shanxi, China

The First Affiliated Hospitol of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

The First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

The First Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China