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

Sponsor
Sunshine Lake Pharma Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05397379
Collaborator
(none)
78
Enrollment
9
Locations
5
Arms
13.5
Anticipated Duration (Months)
8.7
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Nov 15, 2021
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [12 weeks]

Secondary Outcome Measures

  1. 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]

  2. Plasma concentration of HEC96719 - AUC [4 weeks]

    Area under the curve

  3. Plasma concentration of HEC96719 - Cmax [4 weeks]

    Maximum observed concentration

  4. Plasma concentration of HEC96719 - Tmax [4 weeks]

    Time to reach maximum measured plasma concentration

  5. Plasma concentration of HEC96719 - t1/2 [4 weeks]

    Determination of half-life

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University People's Hospital Beijing Beijing 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
5 Hunan Provincial People's Hospital Changsha Hunan China
6 The First Hospital of Jilin University Changchun Jilin China
7 The First Affiliated Hospitol of Xi'an Jiaotong University Xi'an Shanxi China
8 The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang China
9 The First Affiliated Hospitol of Wenzhou Medical University Wenzhou Zhejiang China

Sponsors and Collaborators

  • Sunshine Lake Pharma Co., Ltd.

Investigators

  • Study Chair: Jinlin Hou, Doctor, Nanfang Hospital of Southern Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sunshine Lake Pharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05397379
Other Study ID Numbers:
  • HEC96719-NASH-201
First Posted:
May 31, 2022
Last Update Posted:
May 31, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of May 31, 2022