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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: HRS-4729 Injection | Experimental |
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| Treatment group B: HRS9531 Injection | Experimental |
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| Treatment group C: HRS-4729 Injection Placebo | Placebo Comparator |
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| Treatment group D: HRS9531 Injection Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-4729 Injection | Drug | HRS-4729 Injection; high dose, low dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mengshan Ni | Contact | +86-0518-81220121 | mengshan.ni.mn1@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tsinghua Changgung Hospital | Beijing | Beijing Municipality | 102218 | China |
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| HRS9531 Injection |
| Drug |
HRS9531 Injection; high dose, low dose |
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| HRS-4729 Injection Placebo | Drug | HRS-4729 Injection Placebo |
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| HRS9531 Injection Placebo | Drug | HRS9531 Injection Placebo |
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| 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 |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
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