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A Study of HRS-4729 Injection and HRS9531 Injection in Participants With Metabolic Dysfunction-Associated Steatohepatitis
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)
Lead sponsor
Asset
HRS9531
Subcutaneous · GLP-1 / GIP dual
Listed sites
2
Recruiting sites
—
Enrollment
160
estimated
Study population
MASH / NAFLD / liver fibrosis
Key I/E criterion
•BMI ≥24
Primary endpoint
•Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Endpoints (6)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
MASH / liver
5 endpointsPercent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
Time frame:Baseline, Week 32
percent change from baseline, improvement
Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
Time frame:Baseline, Week 52
percent change from baseline, improvement
Percentage of Participants With Absence of MASH With no Worsening of Fibrosis on Liver Histology
Time frame:Baseline, Week 52
threshold achievement, improvement
Percentage of Participants With ≥ 1 Point Decrease in Fibrosis Stage With No Worsening of MASH on Liver Histology
Time frame:Baseline, Week 52
threshold achievement, improvement
Percentage of Participants With ≥ 1 Point Decrease in Fibrosis Stage on Liver Histology
Time frame:Baseline, Week 52
threshold achievement, improvement
Safety / tolerability / PK
1 endpointTreatment-Emergent Adverse Events (TEAEs)
Time frame:Baseline, Week 56
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.