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A Randomized, Double-blind, Placebo-controlled Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)

Primary Purpose

Nonalcoholic Steatohepatitis (NASH)

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
ZSP1601
ZSP1601
Placebo
Sponsored by
Guangdong Raynovent Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Steatohepatitis (NASH)

Eligibility Criteria

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

Inclusion Criteria: NASH histological diagnosis on a liver biopsy performed ≤ 24 weeks before randomization, and NAS≥4 (at least 1 point each in inflammation and ballooning), and fibrosis score F2 or F3, and no other chronic liver disease Subjects having given her/his written informed consent Good compliance with the protocol and agree to have liver biopsy performed Subjects (including their partners) agreed to use effective contraception throughout the study period and up to 24 weeks after discontinuation Exclusion Criteria: History of cirrhosis or liver biopsy suggestive of cirrhosis Metabolic surgery or new technology treatment for weight loss within 5 years prior to randomization or planned during the study period Type 1 diabetes HIV infection Patients with severe or uncontrollable underlying diseases, unsuitable for treatment with ZSP1601, unable to complete study follow-up, or likely to affect the evaluation of trial results judged by investigator Previous malignancy within 5 years Treatment with hepatoprotective drugs Excessive alcohol consumption for 12 or more consecutive weeks within 1 year prior to screening Pregnant and lactating women or those with a positive serum pregnancy test.

Sites / Locations

  • NanFang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ZSP1601 50mg BID

ZSP1601 100 mg BID

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percent of patients with improvement of steatohepatitis and no worsening of liver fibrosis or improvement in liver fibrosis greater than or equal to one stage and no worsening of the steatohepatitis
Percent of patients with improvement of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis on NASH-CRN Fibrosis Score or improvement in liver fibrosis greater than or equal to one stage and no worsening of the steatohepatitis

Secondary Outcome Measures

Percent of patients with resolution of steatohepatitis and no worsening of fibrosis or improvement of fibrosis by at least 1 stage and no worsening of steatohepatitis
Percent of patients with steatohepatitis improvement and improvement of fibrosis by at least 1 stage
Percent of patients with steatohepatitis resolution and improvement of fibrosis by at least 1 stage
Percent of patients with steatohepatitis resolution and no worsening of fibrosis
Percent of patients with steatohepatitis improvement and no worsening of fibrosis
Change from baseline in liver fat content (LFC) as measured by MRI-PDFF
Change from baseline in liver chemistry(ALT,AST,GGT)

Full Information

First Posted
December 25, 2022
Last Updated
June 6, 2023
Sponsor
Guangdong Raynovent Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05692492
Brief Title
A Randomized, Double-blind, Placebo-controlled Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)
Official Title
A Randomized, Double-blind, Placebo-controlled Phase 2b Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2023 (Actual)
Primary Completion Date
June 16, 2026 (Anticipated)
Study Completion Date
December 16, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Raynovent Biotech 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
The purpose of this research is to evaluate the efficacy and the safety of two doses of ZSP1601 for 48 weeks versus placebo in adult NASH patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis (NASH)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ZSP1601 50mg BID
Arm Type
Experimental
Arm Title
ZSP1601 100 mg BID
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ZSP1601
Intervention Description
50mg BID
Intervention Type
Drug
Intervention Name(s)
ZSP1601
Intervention Description
100mg BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Percent of patients with improvement of steatohepatitis and no worsening of liver fibrosis or improvement in liver fibrosis greater than or equal to one stage and no worsening of the steatohepatitis
Description
Percent of patients with improvement of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis on NASH-CRN Fibrosis Score or improvement in liver fibrosis greater than or equal to one stage and no worsening of the steatohepatitis
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Percent of patients with resolution of steatohepatitis and no worsening of fibrosis or improvement of fibrosis by at least 1 stage and no worsening of steatohepatitis
Time Frame
48 weeks
Title
Percent of patients with steatohepatitis improvement and improvement of fibrosis by at least 1 stage
Time Frame
48 weeks
Title
Percent of patients with steatohepatitis resolution and improvement of fibrosis by at least 1 stage
Time Frame
48 weeks
Title
Percent of patients with steatohepatitis resolution and no worsening of fibrosis
Time Frame
48 weeks
Title
Percent of patients with steatohepatitis improvement and no worsening of fibrosis
Time Frame
48 weeks
Title
Change from baseline in liver fat content (LFC) as measured by MRI-PDFF
Time Frame
48 weeks
Title
Change from baseline in liver chemistry(ALT,AST,GGT)
Time Frame
48 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: NASH histological diagnosis on a liver biopsy performed ≤ 24 weeks before randomization, and NAS≥4 (at least 1 point each in inflammation and ballooning), and fibrosis score F2 or F3, and no other chronic liver disease Subjects having given her/his written informed consent Good compliance with the protocol and agree to have liver biopsy performed Subjects (including their partners) agreed to use effective contraception throughout the study period and up to 24 weeks after discontinuation Exclusion Criteria: History of cirrhosis or liver biopsy suggestive of cirrhosis Metabolic surgery or new technology treatment for weight loss within 5 years prior to randomization or planned during the study period Type 1 diabetes HIV infection Patients with severe or uncontrollable underlying diseases, unsuitable for treatment with ZSP1601, unable to complete study follow-up, or likely to affect the evaluation of trial results judged by investigator Previous malignancy within 5 years Treatment with hepatoprotective drugs Excessive alcohol consumption for 12 or more consecutive weeks within 1 year prior to screening Pregnant and lactating women or those with a positive serum pregnancy test.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinlin Hou
Phone
02061641888
Email
jlhousmu@163.com
Facility Information:
Facility Name
NanFang Hospital
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinlin Hou
Phone
020-61641888
Email
jlhousmu@163.com

12. IPD Sharing Statement

Learn more about this trial

A Randomized, Double-blind, Placebo-controlled Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)

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