Study assessments
NAFLD, itch, sleep disturbance, (PGIS).Predose, liver damage, fibrosis, NASH, lobular inflammation, steatosis, steatohepatitis
LIVER DAMAGE, FIBROSIS, BLOOD, STEATOSIS, STEATOHEPATITIS
Safety assessments were performed to assess the occurrence of AEs, serious AEs (SAEs), AEs leading to study discontinuation or dose reduction, AEs of special interest (AESIs), changes in vital signs, and changes in laboratory data. AEs, SAEs, and vital signs were assessed at screening; baseline; weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, and 48; and post-treatment follow-up at week 52.To assess treatment-induced changes, paired liver biopsies (baseline and EOT) were reviewed by a central pathologist (blinded to visits and treatment) to score fibrosis staging and grading of steatohepatitis features (steatosis, lobular inflammation, and hepatocyte ballooning). Real-time readings of liver biopsies were also performed at baseline to assess eligibility for entry into the study and after treatment completion. See Supplemental Information, The NAFLD activity score (NAS) was calculated according to the NASH CRN criteria,MRI-PDFF was performed optionally in a subset of patients to quantify HFF at screening. All MRI scans were performed locally and sent to the central MRI laboratory for evaluation. Anthropometric assessments included height and body weight.Blood samples and fasting blood samples were collected to assess liver biochemistry, which included ALT, aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), and lipid panels (ie, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, free glycerol, and free fatty acids).A number of noninvasive tests were performed to assess liver damage and function. See Supplemental Information, Patient-reported outcomes included the visual analog scale (VAS) for itch, VAS for sleep disturbance due to itch, Patient Global Impression of change (PGIC; end of study [EOS] only), and Patient Global Impression of severity (PGIS).Predose and postdose PK plasma samples were collected at specified time intervals over the study duration (weeks 4, 8, 12, 24, and 48). See Supplemental Information, 