HSK31679 compared with placebo in adults with metabolic dysfunction-associated steatohepatitis
Tests the drug HSK31679 against placebo in adults with MASH, a fatty liver disease.
Plain-language title generated from the registry record
Registry title: A Phase 3 Study Evaluating the Safety and Efficacy of HSK31679 in Patients With MASH
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 3
Where in China
- Beijing Tsinghua Changgung HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Haisco Pharmaceutical Group Co., Ltd.
- Trial code
- NCT07581951
- Record updated
- 23 September 2026
- Original description
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) .Read full original descriptionShow less
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of HSK31679 in Patients With Metabolic Dysfunction Associated Steatohepatitis (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) .
Inclusion: 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.
Exclusion: 1. History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening; 3.Received medication therapy that may induce MAFLD/MASH for ≥ 2 weeks within 12 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; 2.MELD score ≥12 due to hepatic disease。; 7.Chronic liver diseases other than NASH; 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); 6.HbA1c ≥ 8.0%; 8.Active autoimmune disease. 9.Serum ALT > 250 U/L. 10.Active, serious medical disease with a likely life expectancy < 2 years.