Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Conditions
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.
Interventions
HRS-4729 Injection; high dose, low dose
HRS9531 Injection; high dose, low dose
HRS-4729 Injection Placebo
HRS9531 Injection Placebo
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) | 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
CONTACTMengshan Ni
Outcome results
None listed