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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
HRS-4729 Injection; high dose, low dose
HRS9531 Injection; high dose, low dose
HRS-4729 Injection Placebo
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
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 (%).
Time frame: Baseline, Week 32
Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
Time frame: Baseline, Week 52
Percentage of Participants With Absence of MASH With no Worsening of Fibrosis on Liver Histology
Time frame: Baseline, Week 52
Percentage of Participants With ≥ 1 Point Decrease in Fibrosis Stage With No Worsening of MASH on Liver Histology
Time frame: Baseline, Week 52
Percentage of Participants With ≥ 1 Point Decrease in Fibrosis Stage on Liver Histology
Time frame: Baseline, Week 52
Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline, Week 56
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HRS9531 Injection Placebo