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

Primary Purpose

Non-Alcoholic Steatohepatitis

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HEC96719
Placebo
Sponsored by
Sunshine Lake Pharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Alcoholic Steatohepatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University People's HospitalRecruiting
  • NanFang Hospital of Southern Medical UniversityRecruiting
  • Affiliated Hospitol of Guangdong Medical UniversityRecruiting
  • Union Hospital, TongJi Medical College, HuaZhong University of Science and TechnologyRecruiting
  • Hunan Provincial People's HospitalRecruiting
  • The First Hospital of Jilin UniversityRecruiting
  • The First Affiliated Hospitol of Xi'an Jiaotong UniversityRecruiting
  • The First Affiliated Hospital, Zhejiang University School of MedicineRecruiting
  • The First Affiliated Hospitol of Wenzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

HEC96719 0.25 mg

HEC96719 0.35 mg

HEC96719 0.5 mg

HEC96719 0.25 mg bid

Placebo

Arm Description

Oral dose once daily for 12 weeks

Oral dose once daily for 12 weeks

Oral dose once daily for 12 weeks

Oral dose twice daily for 12 weeks

Oral dose once or twice daily for 12 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 25, 2022
Last Updated
April 10, 2023
Sponsor
Sunshine Lake Pharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05397379
Brief Title
A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of HEC96719 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunshine Lake Pharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Steatohepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HEC96719 0.25 mg
Arm Type
Experimental
Arm Description
Oral dose once daily for 12 weeks
Arm Title
HEC96719 0.35 mg
Arm Type
Experimental
Arm Description
Oral dose once daily for 12 weeks
Arm Title
HEC96719 0.5 mg
Arm Type
Experimental
Arm Description
Oral dose once daily for 12 weeks
Arm Title
HEC96719 0.25 mg bid
Arm Type
Experimental
Arm Description
Oral dose twice daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral dose once or twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
HEC96719
Intervention Description
Oral tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Comparator
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
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
Time Frame
Baseline and Week 12
Title
Plasma concentration of HEC96719 - AUC
Description
Area under the curve
Time Frame
4 weeks
Title
Plasma concentration of HEC96719 - Cmax
Description
Maximum observed concentration
Time Frame
4 weeks
Title
Plasma concentration of HEC96719 - Tmax
Description
Time to reach maximum measured plasma concentration
Time Frame
4 weeks
Title
Plasma concentration of HEC96719 - t1/2
Description
Determination of half-life
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 uncontrolled diabetes mellitus presence of cirrhosis patients with contraindications to MRI imaging
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinlin Hou, Doctor
Phone
61641941
Ext
020
Email
jlhousmu@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinlin Hou, Doctor
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huiying Rao
Facility Name
NanFang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinlin Hou, doctor
Facility Name
Affiliated Hospitol of Guangdong Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Zhou
Facility Name
Union Hospital, TongJi Medical College, HuaZhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongliang Yang
Facility Name
Hunan Provincial People's Hospital
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zheng Zhang
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huifan Ji
Facility Name
The First Affiliated Hospitol of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingren Zhao
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunqin Qiu
Facility Name
The First Affiliated Hospitol of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongping Chen

12. IPD Sharing Statement

Learn more about this trial

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

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