A Phase II Clinical Trial of Chiglitazar for NASH

Inclusion Criteria: 1. Before any evaluation, an informed consent form voluntarily signed by the patient must be obtained; 2. 18 -75 years old (at the time of screening visit V1), male or female; 3. MRI-PDFF ≥ 8% ; 4. Liver stiffness value ( LSM ) 7.0-11.0kPa ; 5. Triglyceride ( TG ) ≥1.7mmol/L and ≤5.6 mmol/L; 6. HOMA-IR ≥ 2.5 ; 7. Serum Alanine aminotransferease (ALT) ≥ the upper limit of normal during screening. Exclusion Criteria: 1. Type 1 diabetes; 2. Any of the following for type 2 diabetes: * HbA1c ≥ 8.5% during screening * At the time of screening, ≥ 2 oral hypoglycemic drugs combinations * Receiving any of the following medications at screening: Thiazolidinediones (TZD) drugs, fibrates, glucagon-like peptide-1 (GLP-1) receptor agonists, insulin 3. Existing other liver diseases or history of liver diseases 4. History of transient ischemic attack or cerebrovascular accident; 5. History of myocardial infarction, or coronary angioplasty or coronary artery bypass surgery, unstable angina, heart failure (New York Heart Association NYHA grade III / IV ), or ECG signs of left ventricular hypertrophy, or serious arrhythmias ； 6. During screening, blood pressure ≥ 160/100 mmHg ; 7. Previous or planned ( during the study period) bariatric surgery; 8. Liver transplantation history or planned liver transplantation; 9. Liver biopsy show liver cirrhosis or clinically diagnosed as cirrhosis; 10. Weight loss of more than 5% in 6 months before screening; 11. History of edema of lower limbs or whole body; 12. diagnosed as osteoporosis or any other known bone disease; 13. Donated blood or lost blood \>400 ml within 8 weeks before the first medication; 14. With MRI scan contraindications; 15. In the past 5 years, there was a history of malignant tumors of any organ system; 16. Human immunodeficiency virus ( HIV ) test is positive; 17. Heavy drinking of alcohol for more than 3 months in a year; 18. Heavy smoking \>30 per day within 1 year; 19. History of drug abuse in 12 months; 20. Drugs cumulatively for more than 1 month in the previous 3 months before screening, such as obeticholic acid ( OCA ), berberine; 21. Drugs that may cause liver damage for more than 2 weeks within 1 year before screening; 22. Patients received the following medications unless they have received a stable dose for at least 1 month before screening :Beta-blockers, thiazide diuretics, statins, niacin, ezetimibe, thyroid hormone; 23. The calculated eGFR \< 60 mL/(min\*1.73m\^2 ); 24. There is clinical evidence of liver decompensation or severe liver damage; 25. Low density lipoprotein cholesterol (LDL-C) ≥ 3.4 mmol/L during screening ; 26. Platelet \< 100×10\^9 /L ; 27. Patient participating in other clinical trials of drugs or medical devices within 3 months prior to screening ; 28. Pregnant or breastfeeding women.