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Clinical Trials in China / NCT05692492
Active, not recruiting Phase 2

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

NCT05692492 · tracked via the Priya Life Science China tracker
Sponsor
Guangdong Raynovent Biotech Co., Ltd
Phase
Phase 2
Started
2023-06-03
Last updated
2025-03-19

Condition(s) studied

Nonalcoholic Steatohepatitis (NASH)

Investigational drug(s) / intervention(s)

ZSP1601ZSP1601Placebo

ZSP1601: 50mg BID

ZSP1601: 100mg BID

Placebo: Placebo

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. 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 2. Subjects having given her/his written informed consent 3. Good compliance with the protocol and agree to have liver biopsy performed 4. Subjects (including their partners) agreed to use effective contraception throughout the study period and up to 24 weeks after discontinuation Exclusion Criteria: 1. History of cirrhosis or liver biopsy suggestive of cirrhosis 2. Metabolic surgery or new technology treatment for weight loss within 5 years prior to randomization or planned during the study period 3. Type 1 diabetes 4. HIV infection 5. 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 6. Previous malignancy within 5 years 7. Treatment with hepatoprotective drugs 8. Excessive alcohol consumption for 12 or more consecutive weeks within 1 year prior to screening 9. Pregnant and lactating women or those with a positive serum pregnancy test.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
NanFang Hospital Guangzhou China

More Guangdong Raynovent Biotech Co., Ltd trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05692492 on ClinicalTrials.gov ↗ ← All trials in China