← Trials/Trial dossier/NCT07660848

Not yet recruitingPhase 2

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)

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

NCT IDNCT07660848
Org study IDHRS-4729-201

Timeline

Milestones

Study first posted2026-06-22actual
Last update posted2026-06-22actual
Study start2026-07estimated (month precision)
Primary completion2028-03estimated (month precision)
Study completion2028-07estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosis

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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
Safety / tolerability / PK
1

MASH / liver

5 endpoints
Primary/protocol endpoint

Percent 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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Time frame:Baseline, Week 52

threshold achievement, improvement

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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 endpoint
Secondary/protocol endpoint

Treatment-Emergent Adverse Events (TEAEs)

Time frame:Baseline, Week 56

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.