A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of HSK31679 compared to placebo in patients with metabolic dysfunction-associated steatohepatitis (MASH) .
This study has 2 parts.Participants will be assigned to Part 1 based on screening histologic (liver biopsy) criteria or non-invasive test criteria. The purpose of the first part of this study is to find out the effect of HSK31679 on MASH and liver fibrosis. Participants will be assigned to Part 2 based on non-invasive test criteria.The purpose of the second part is to find out how safe HSK31679 is in improving liver function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
886
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
RECRUITINGNumber of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52.
Resolution of steatohepatitis is defined as total absence of ballooning (score=0) and absent or mild inflammation (score 0 to 1). Worsening of fibrosis is defined as progression of fibrosis by ≥1 stage.
Time frame: Week 52
Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52.
Worsening of steatohepatitis is defined as increase in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation, or steatosis.
Time frame: Week 52
Time to First Occurrence of Disease Progression
Final analysis of the time to first occurrence of disease progression will be measured by a composite of protocol-specified clinical events
Time frame: Up to 4.5 years
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