This is a phase 2, randomized, double-blind, placebo controlled study in adults with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of ASC41 in adults with NASH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
2mg of ASC41 orally once daily for 52 weeks
4mg of ASC41 orally once daily for 52 weeks
Matching placebo orally once daily for 52 weeks.
Percent of ASC41 subjects compared to placebo with histological reduction in NAS ≥2 points that results from reduction of inflammation or ballooning and no worsening fibrosis assessed by histopathological reading of liver biopsy at Week 52
Time frame: Baseline to Week 52
Safety and tolerability of ASC41 evaluated by incidence of treatment emergent adverse events (TEAEs) in ASC41 treated subjects compared to placebo
Time frame: Baseline to Week 52
Change in hepatic fat fraction based on MRI-PDFF measurements in ASC41 treated subjects compared to placebo.
Time frame: Baseline to Week 12 and Week 52
Resolution of NASH on overall histopathological reading of liver biopsy specimen taken at Week 52 compared to baseline in ASC41 treated subjects compared to placebo treated subjects
Time frame: Baseline to Week 52
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