HRS-4729 and HRS9531 injections in adults with MASH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 trial evaluates the safety and effectiveness of two investigational injections, HRS-4729 and HRS9531, in adults with MASH. Participants are randomized to receive each active drug or a placebo, with outcomes assessed after one year of treatment. Eligible participants have a liver biopsy-confirmed MASH, liver fat ≥8%, and BMI between 24 and 40 kg/m² with stable weight. Key exclusions include advanced liver disease, recent alcohol misuse, cirrhosis, and other liver conditions. The study is sponsored by Fujian Shengdi Pharmaceutical Co., Ltd., with sites in Beijing and Zhengzhou.

Why it matters

Who can join: the full rules

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 ≥8%
4. 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

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, α1-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

Where it's running

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

Study contacts

• Study coordinator: Mengshan Ni
• Email: mengshan.ni.mn1@hengrui.com
• Phone: +86-0518-81220121

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.