To Evaluate the Efficacy and Safety of HSK31679 in Chinese Patients With Non-Alcoholic Steatohepatitis (NASH) .

Exclusion Criteria

• •1. History or presence of cirrhosis，hepatic decompensation or impairment defined as presence of any of the following: history of esophageal varices, ascites, or hepatic encephalopathy, or hepatocellular carcinoma.
• •2. Use of high dose vitamin E (\>400 IU/day)，polyunsaturated fatty acid or ursodeoxycholic acid unless stable for ≥6 months prior to an eligible screening liver biopsy. Use of thiazolidinediones, sodium-glucose co-transporter 2 inhibitors or a complex oral anti-diabetic (OAD) regimen (3 or more OADs) unless stable for ≥3 months prior to an eligible screening liver biopsy.
• •3. Use of Glucagon-like peptide 1 \[GLP-1\] agonist therapy (e.g.,liraglutide, semaglutide, dulaglutide and exenatide ) within 6 months prior to an eligible screening liver biopsy.
• •4. Use of drugs that have the potential to affect thyroid hormone production and/or interfere with thyroid function.
• •5. Potent inhibitors of CYP2C8 such as gemfibrozil and trimethoprim are prohibited. An inducer of CYP2C8, rifampicin, is prohibited.
• •6. Use of drugs historically associated with NAFLD/NASH for 2 weeks prior to an eligible screening liver biopsy, which include, but are not limited, to the following: total parenteral nutritionamiodarone, methotrexate, systemic glucocorticoids (if use within 3 months prior to a biopsy is also not permitted), tamoxifen, tetracycline, estrogens at doses greater than those used for hormone replacement or contraception, anabolic steroids , valproic acid, and known hepatotoxins.
• •7. Regular use of drugs historically associated with NAFLD/NASH within 12 months prior to liver biopsy (including historical biopsy), which include, but are not limited, to the following:PPAR agonists (e.g. lanifibranor, Siglitazone sodium) ，FXR agonists (e.g., obecholic acid, HTD1801)，FGF21 analogs (e.g., AP025, efruxifermin , pegozafermin(B1089-1001)) ; DGAT2 inhibitors (e.g., PF 6865571 and ION224),PDE inhibitors (e.g., ZSP1601) and other thyroid hormone receptor B agonists \[e.g.,resmetirom（MGL-3196）、ASC41 and VK2809).
• •8. Lipid-lowering therapy that did not meet the following criteria: fenofibrate, ezetimibe stable for at least 3 months before randomization and remained unchanged during study treatment, and statins stable for at least 4 weeks before randomization and remained unchanged during study treatment.
• •9. Type 1 diabetes or uncontrolled Type 2 diabetes defined as:
• •* Hemoglobin A1c \>9.5% at screening (patients with HbA1c \>9.5% may be rescreened),
• •* Insulin dose adjustment \>20% within 60 days prior to enrollment,
• •* Requirement for glucagon-like peptide analogue (unless on a stable dose ≥ 6 months prior to screening) or History of severe hypoglycemia (symptomatic hypoglycemia requiring outside assistance to regain normal neurologic status).
• •10. Uncontrolled hypertension (either treated or untreated) defined as systolic blood pressure \>160 mmHg or a diastolic blood pressure \>100 mmHg at screening.
• •11. Evidence of other forms of chronic liver disease including the following:biliary bypass, drug induced liver disease, alcoholic liver disease, autoimmune hepatitis, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), hemohemosis, Wilson's disease, α-1 antitrypsin deficiency, bile duct obstruction, primary or metastatic liver cancer, hepatitis B, or present Hepatitis virus (HCV) infection.
• •12. Thyroid diseases: hyperthyroidism and hypothyroidism. Thyroid peroxidase antibodies (TPOAb) or thyroglobulin antibodies (TGAb) that have been determined by the investigators to be clinically significant.
• •13. Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within 6 months prior to screening.
• •14. New York Heart Association class III or IV heart failure, or known left ventricular ejection fraction \<30%.
• •15. Serum ALT or AST \>5 × ULN; Serum ALP≥2× ULN；eGFR\<60 mL/min/1.73m2；INR\>1.5× ULN；platelets \< 80×109/L.
• •16. Participation in an investigational new drug trial in the 90 days prior to randomization.
• •17. Any other condition which, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes.