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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Shengdi Pharmaceutical Co., Ltd.

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

Treatment groups

160 Participants
are divided into 4 treatment groups