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A Study of HRS-4729 Injection and HRS9531 Injection in Participants With Metabolic Dysfunction-Associated Steatohepatitis

RecruitingPhase 2Ages 18 Years - 75 YearsAllFujian Shengdi Pharmaceutical Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Able and willing to provide a written informed consent 2. Participants must have histologic diagnosis of MASH by liver biopsy 3. Have liver fat content โ‰ฅ8% 4. Participants must have a body mass index (BMI) โ‰ฅ24 kilograms per square meter (kg/mยฒ) and โ‰ค40 kg/mยฒ with stable body weight for at least 3 months Exclusion Criteria: 1. Model for End-Stage Liver Disease (MELD) score \> 12, or Child-Pugh (CTP) score \> 6 2. Known or suspected history of excessive alcohol consumption or alcohol dependence within 12 months prior to screening 3. History of liver cirrhosis and/or liver decompensation, including but not limited to ascites, hepatic encephalopathy, esophageal or gastric variceal bleeding, etc. 4. 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, ฮฑ1-antitrypsin deficiency, Wilson's disease, etc.), occupational toxic liver disease, known or suspected hepatocellular carcinoma (HCC), etc. 5. History of or planned organ transplantation (e.g., liver transplant) or bone marrow transplantation during the study period 6. 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 7. Known or suspected hypersensitivity to GLP-1 and/or GIP and/or GCG receptor agonists and/or their excipient
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What it tests

  • HRS-4729 Injection
  • HRS9531 Injection
  • HRS-4729 Injection Placebo
  • HRS9531 Injection Placebo
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Where

2 sites
Beijing Tsinghua Changgung Hospital
Beijing, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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