A Randomized, Double-blind, Placebo-controlled Phase 2b Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)

Guangdong Raynovent Biotech Co., Ltd1 site in 1 country180 target enrollmentJune 3, 2023

ConditionsNonalcoholic Steatohepatitis (NASH)

InterventionsZSP1601 Placebo

DrugsZSP1601 Placebo

Overview

Phase: Phase 2
Intervention: ZSP1601
Conditions: Nonalcoholic Steatohepatitis (NASH)
Sponsor: Guangdong Raynovent Biotech Co., Ltd
Enrollment: 180
Locations: 1
Primary Endpoint: 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
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 3, 2023

End Date

December 16, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Guangdong Raynovent Biotech Co., Ltd

Responsible Party

Sponsor

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.

Arms & Interventions

ZSP1601 50mg BID

Intervention: ZSP1601

ZSP1601 100 mg BID

Intervention: ZSP1601

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: 48 weeks

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 Outcomes

Percent of patients with steatohepatitis resolution and improvement of fibrosis by at least 1 stage(48 weeks)
Percent of patients with steatohepatitis resolution and no worsening of fibrosis(48 weeks)
Change from baseline in liver chemistry（ALT,AST,GGT）(48 weeks)
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(48 weeks)
Change from baseline in liver fat content (LFC) as measured by MRI-PDFF(48 weeks)
Percent of patients with steatohepatitis improvement and improvement of fibrosis by at least 1 stage(48 weeks)
Percent of patients with steatohepatitis improvement and no worsening of fibrosis(48 weeks)