NCT07660848招募中2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Master Protocol Clinical Trial to Investigate the Efficacy and Safety of HRS-4729 Injection and HRS9531 Injection in Adult Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of HRS-4729 injection and HRS9531 injection in adult participants with metabolic dysfunction-associated steatohepatitis after 52 weeks of treatment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide a written informed consent
- •Participants must have histologic diagnosis of MASH by liver biopsy
- •Have liver fat content ≥8%
- •Participants must have a body mass index (BMI) ≥24 kilograms per square meter (kg/m²) and ≤40 kg/m² with stable body weight for at least 3 months
排除标准
- •Model for End-Stage Liver Disease (MELD) score > 12, or Child-Pugh (CTP) score > 6
- •Known or suspected history of excessive alcohol consumption or alcohol dependence within 12 months prior to screening
- •History of liver cirrhosis and/or liver decompensation, including but not limited to ascites, hepatic encephalopathy, esophageal or gastric variceal bleeding, etc.
- •Previous or current liver disease due to other causes, including but not limited to: alcoholic steatohepatitis (ASH), drug-induced liver injury (DILI), viral hepatitis, autoimmune hepatitis (AIH), primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), hereditary hepatobiliary diseases (e.g., hemochromatosis, α1-antitrypsin deficiency, Wilson's disease, etc.), occupational toxic liver disease, known or suspected hepatocellular carcinoma (HCC), etc.
- •History of or planned organ transplantation (e.g., liver transplant) or bone marrow transplantation during the study period
- •Use of GLP-1 receptor agonists (including multi-target drugs or compound preparations containing GLP-1 receptor agonists) within 3 months prior to screening, or previous discontinuation of GLP-1 receptor agonists due to safety/tolerance reasons
- •Known or suspected hypersensitivity to GLP-1 and/or GIP and/or GCG receptor agonists and/or their excipient
研究者
研究点 (2)
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