NCT07581951尚未招募3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of HSK31679 in Patients With Metabolic Dysfunction Associated Steatohepatitis (MASH)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 400
研究概览
简要总结
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) .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 < F
- •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.
排除标准
- •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.
研究组 & 干预措施
HSK31679 dose
Experimental
HSK31679 tablet, orally, once daily
干预措施: HSK31679 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
研究者
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