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) .
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%.
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).