A Phase 3 Study Evaluating the Safety and Efficacy of HSK31679 in Patients With MASH

A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of HSK31679 compared to placebo in patients with metabolic dysfunction-associated steatohepatitis (MASH) .

Key Inclusion Criteria: * 1\. Must be willing to participate in the study and provide written informed consent. * 2.Male and female adults ≥ 18 years of age. * 3.Have at least one cardiometabolic risk factors at screening. * 4.MRI-PDFF fat fraction ≥8%. * 5.Have a liver biopsy performed within 6 months prior to randomization, with histologically confirmed MASH assessed by the central laboratory; NAS score ≥ 4 points with at least 1 point each for inflammation and hepatocellular ballooning; meanwhile, CRN fibrosis stage is F2 ≤ fibrosis \< F4. If no liver biopsy data are available within 6 months prior to randomization, a liver biopsy must be completed during the screening period. * 6.Body weight fluctuation \< 5% for at least 6 weeks before randomization. Key Exclusion Criteria: * 1\. History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening. * 2.MELD score ≥12 due to hepatic disease。 * 3.Received medication therapy that may induce MAFLD/MASH for ≥ 2 weeks within 12 months prior to liver biopsy (including historical biopsy). * 4.Participants who had not been on stable medication with vitamin E (dose\>400 IU/day) or polyunsaturated fatty acids or ursodeoxycholic acid within 6 months prior to liver biopsy (including historical biopsy); or had not been on stable medication with thiazolidinediones (TZD), sodium-glucose cotransporter 2 (SGLT2) inhibitors, or complex oral antidiabetic (OAD) regimens (≥3 OADs) within 3 months prior to liver biopsy (including historical biopsy). * 5.Participants who have undergone bariatric surgery (e.g., gastroplasty, Roux-en-Y gastric bypass, etc.) within 5 years prior to screening or plan to receive such surgery during the study. * 6.HbA1c ≥ 8.0%. * 7.Chronic liver diseases other than NASH. * 8.Active autoimmune disease. 9.Serum ALT \> 250 U/L. 10.Active, serious medical disease with a likely life expectancy \< 2 years.