About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- HRS-4729 Injection
- HRS9531 Injection
- HRS-4729 Injection Placebo
- HRS9531 Injection Placebo