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

NCT07660848 | Not Yet Recruiting Phase 2

• 1 other identifier: HRS-4729-201
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Outcome Measures

Primary Outcomes (1)

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

  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 (%).

  Baseline, Week 32

Secondary Outcomes (5)

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

  Baseline, Week 52

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

  Baseline, Week 52

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

  Baseline, Week 52

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

  Baseline, Week 52

• Treatment-Emergent Adverse Events (TEAEs)

  Baseline, Week 56

Study Arms (4)

Treatment group A: HRS-4729 Injection

EXPERIMENTAL

Drug: HRS-4729 Injection

Treatment group B: HRS9531 Injection

EXPERIMENTAL

Drug: HRS9531 Injection

Treatment group C: HRS-4729 Injection Placebo

PLACEBO COMPARATOR

Drug: HRS-4729 Injection Placebo

Treatment group D: HRS9531 Injection Placebo

PLACEBO COMPARATOR

Drug: HRS9531 Injection Placebo

Interventions

HRS-4729 Injection DRUG

HRS-4729 Injection; high dose, low dose

Treatment group A: HRS-4729 Injection

HRS9531 Injection DRUG

HRS9531 Injection; high dose, low dose

Treatment group B: HRS9531 Injection

HRS-4729 Injection Placebo DRUG

HRS-4729 Injection Placebo

Treatment group C: HRS-4729 Injection Placebo

HRS9531 Injection Placebo DRUG

HRS9531 Injection Placebo

Treatment group D: HRS9531 Injection Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Central Study Contacts

Mengshan Ni

CONTACT

+86-0518-81220121; mengshan.ni.mn1@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

CN (2)