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

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.

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 diseaseSubjects having given her/his written informed consentGood compliance with the protocol and agree to have liver biopsy performedSubjects (including their partners) agreed to use effective contraception throughout the study period and up to 24 weeks after discontinuationExclusion Criteria:History of cirrhosis or liver biopsy suggestive of cirrhosisMetabolic surgery or new technology treatment for weight loss within 5 years prior to randomization or planned during the study periodType 1 diabetesHIV infectionPatients 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 investigatorPrevious malignancy within 5 yearsTreatment with hepatoprotective drugsExcessive alcohol consumption for 12 or more consecutive weeks within 1 year prior to screeningPregnant and lactating women or those with a positive serum pregnancy test.