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).
Parallel
HSK31679
Drugtablet
Placebo
DrugMatching tablet
Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52.
Resolution of steatohepatitis is defined as total absence of ballooning (score=0) and absent or mild inflammation (score 0 to 1). Worsening of fibrosis is defined as progression of fibrosis by ≥1 stage.
Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52.
Worsening of steatohepatitis is defined as increase in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation, or steatosis.
Time to First Occurrence of Disease Progression
Final analysis of the time to first occurrence of disease progression will be measured by a composite of protocol-specified clinical events
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