Efficacy evaluation
Obesity, TNF-α, Fibrosis, TG, steatosis
OBESITY, LIVER, LIVER FIBROSIS, FIBROSIS, INSULIN RESISTANCE, STEATOSIS
Efficacy evaluations were performed in subjects who completed the trial. The exploratory efficacy outcomes were changes from baseline in liver biochemical tests (ALT, AST, ALP, and GGT), LFC as examined by MRI-PDFF, FibroScan values with two parameters (LSM and CAP using transient elastography) for evaluation of liver fibrosis and steatosis, FAST score, AST to platelet ratio index (APRI), Fibrosis 4 (Fib 4), inflammatory cytokines (TNF-α, IL-6, IL-10, and IL-22) and other potential noninvasive serum biomarkers (IP-10, CK-18), lipid panel tests [total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)], serum insulin, glucose, and calculate Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Obesity parameters [body weight, body-mass index (BMI), waist circumference, abdominal circumference]. All the MRI-PDFF and LSM were measured in the study subjects at baseline and after the end of the treatment at day 29 (D29) in the placebo, ZSP1601 50 mg QD, ZSP1601 50 mg BID, and ZSP1601 100 mg QD groups. Liver biochemical tests (serum ALT, AST, ALP, and GGT), and other laboratory tests were examined at baseline, during treatment at day 7, day 14, day 22, upon completion of the 28-day treatment (D29), and 14 days after treatment with ZSP1601 (D43) in the placebo, ZSP1601 50 mg QD, ZSP1601 50 mg BID, and ZSP1601 100 mg BID groups.