Schematic diagram of patients selection, enrollment, and study design.
NAFLD, NASH
A total of 95 NASH patients were screened, of which 37 patients were randomized, and 36 NAFLD patients were enrolled in three cohorts. Each cohort included 12 patients, 9 of whom received ZSP1601 50 mg QD, 50 mg BID, or 100 mg BID, and 3 of whom received matching placebos for 28 days. All the 36 patients completed the clinical trial and were scheduled to receive a 14-day treatment-free follow-up.Baseline demographic, laboratory, and clinical characteristicsAge was expressed as median (interquartile range); Categorical data (sex and ethnicity) were expressed as number (percentage), Other data were expressed as mean (standard deviation). Inflammatory cytokines IL-22 and IL-10 were not detectable at baseline.