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

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Metabolic Dysfunction-Associated Steatohepatitis (MASH)

In brief

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.

Key facts

Study ID

NCT07660848

Run by

Fujian Shengdi Pharmaceutical Co., Ltd.

People needed

160

Starts

2026-07-01

Expected to finish

2028-07-01

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Beijing Tsinghua Changgung Hospital — Beijing, Beijing Municipality, China
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China

Full record on ClinicalTrials.gov

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