This is a Phase 2, Double-Blind, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults with Nonalcoholic Steatohepatitis (NASH).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
183
ASC41 tablet administered orally once daily.
ASC41 tablets administered orally once daily.
Placebo tablets administered orally once daily.
The affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, China
To evaluate the effect of ASC41 compared with placebo in noncirrhotic subjects with NASH by a histological change.
A histological change in NAFLD (nonalcoholic fatty liver disease) Activity Score (NAS) ≥ 2 points that results from reduction of necroinflammation (inflammation or ballooning) without worsening fibrosis. (The NAFLD Activity Score including steatosis, inflammation and ballooning. The maximum score of steatosis was 3 and the minimum score was 0, the maximum score of inflammation was 3 and the minimum score was 0, and the maximum score of ballooning was 2 and the minimum score was 0. The higher scores mean a worse outcome. )
Time frame: Baseline and Week 52
The incidence, type and severity of AEs/SAEs were assessed by CTCAE v5.0 to assess the safety and tolerability of ASC41 compared to placebo
Time frame: 24 and 52 weeks
Change from baseline in hepatic fat fraction assessed by MRI-PDFF
Time frame: 24 and 52 weeks
To evaluate the effect of ASC41 compared with placebo on serum lipids (cholesterol, HDL-C, LDL-C, triglycerides, Lp(a), VLDL)
Time frame: 12, 24 and 52 weeks
Plasma pharmacokinetics - Peak Plasma Concentration (Cmax)
Measured after administration
Time frame: 1 and 15 Days
Plasma pharmacokinetics - Area under the plasma drug concentration versus time curve( AUC0-t_, AUC0-∞)
Time frame: 1 and 15 Days
Plasma pharmacokinetics - The amount of time that a drug is present at the maximum concentration in serum(Tmax)
Time frame: 1 and 15 Days
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