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NCT Number: NCT07660848

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Tsinghua Changgung Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

HRS-4729 Injection

Drug

HRS-4729 Injection; high dose, low dose

HRS9531 injection

Drug

HRS9531 Injection; high dose, low dose

HRS-4729 Injection Placebo

Drug

HRS-4729 Injection Placebo

HRS9531 injection Placebo

Drug

HRS9531 Injection Placebo

Primary outcomes

  1. Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)

    Time frame: Baseline, Week 32

    MRI-PDFF is an established method that enables quantification of fat content in the liver. The value of whole liver fat as assessed by MRI-PDFF is expressed in percentage (%).

Secondary outcomes

  1. Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)

    Time frame: Baseline, Week 52

  2. Percentage of Participants With Absence of MASH With no Worsening of Fibrosis on Liver Histology

    Time frame: Baseline, Week 52

  3. Percentage of Participants With ≥ 1 Point Decrease in Fibrosis Stage With No Worsening of MASH on Liver Histology

    Time frame: Baseline, Week 52

  4. Percentage of Participants With ≥ 1 Point Decrease in Fibrosis Stage on Liver Histology

    Time frame: Baseline, Week 52

  5. Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Baseline, Week 56

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Master Protocol Clinical Trial to Investigate the Efficacy and Safety of HRS-4729 Injection and HRS9531 Injection in Adult Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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