A randomized, double-blind, placebo-controlled Phase II study，to evaluate the efficacy and safety of TQA2225/AP025 in Patients With Non-Alcoholic Steatohepatitis (NASH)
Must be willing to participate in the study and provide written informed consent.
Male or female aged 18 ≤ age < 75 at the time of signing the informed consent.
Must have had prior liver biopsy within 180 days of randomization with fibrosis stage 1 to 3 and a NAS of ≥4 with at least a score of 1 in each of the lobular inflammation and ballooning degeneration.
Confirmation of ≥10% liver fat content on Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF).
Documented causes of chronic liver disease other than NASH
Type 1 diabetes or uncontrolled Type 2 diabetes defined as:Hemoglobin A1c ≥9% at screening，Fasting blood glucose≥13.9mmol/l
Uncontrolled hypertension at Screening (values ≥160/100 mm Hg)
History or presence of cirrhosis
Parallel
TQA2225/AP025 or TQA2225/AP025 Placebo 25mg
DrugTo evaluate the efficacy and safety of TQA2225/AP025 (25mg) in patients with Non-Alcoholic Steatohepatitis (NASH)
TQA2225/AP025 or TQA2225/AP025 Placebo 50mg
DrugTo evaluate the efficacy and safety of TQA2225/AP025 (50mg) in patients with Non-Alcoholic Steatohepatitis (NASH)
To determine the effect of 25 or 50mg TQA2225 vs matching placebo on liver biopsy (NASH CRN score) at Week 48 compared with Baseline
1. Proportion with resolution of NASH (ballooning 0, inflammation 0,1) associated with at least 2-point reduction in NAFLD Activity Score (NAS) without worsening of fibrosis stage OR 2. Proportion with at least a 1-point improvement in fibrosis stage with no worsening of NAS
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number and percentage of adverse events and serious adverse events
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