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Not yet recruiting NCT07660848

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

Phase II Interventional Metabolic Dysfunction-Associated Steatohepatitis (MASH)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HRS-4729 Injection, HRS9531 Injection, HRS-4729 Injection Placebo, HRS9531 Injection Placebo.
Who it may be relevant to
Registry conditions: Metabolic Dysfunction-Associated Steatohepatitis (MASH). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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)

Overview

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.

Interventions

  • Drug HRS-4729 Injection
    HRS-4729 Injection; high dose, low dose
  • Drug HRS9531 Injection
    HRS9531 Injection; high dose, low dose
  • Drug HRS-4729 Injection Placebo
    HRS-4729 Injection Placebo
  • Drug HRS9531 Injection Placebo
    HRS9531 Injection Placebo

Primary outcome measures

  • Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) [Time frame: Baseline, Week 32]
Secondary outcome measures (5)
  • Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) [Time frame: Baseline, Week 52]
  • Percentage of Participants With Absence of MASH With no Worsening of Fibrosis on Liver Histology [Time frame: Baseline, Week 52]
  • Percentage of Participants With ≥ 1 Point Decrease in Fibrosis Stage With No Worsening of MASH on Liver Histology [Time frame: Baseline, Week 52]
  • Percentage of Participants With ≥ 1 Point Decrease in Fibrosis Stage on Liver Histology [Time frame: Baseline, Week 52]
  • Treatment-Emergent Adverse Events (TEAEs) [Time frame: Baseline, Week 56]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • Beijing Tsinghua Changgung Hospital — Beijing
  • The First Affiliated Hospital of Zhengzhou University — Zhengzhou

Identifiers

NCT: NCT07660848 · HRS-4729-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗