Hepatology

ALT, AST, ALP, GGT, total/direct bilirubin, albumin, INR from central laboratory. Normalized to ULN for Hy's law screening.

Liver stiffness (kPa, M and XL probe) and CAP measurements from Echosens FibroScan 530/630 devices used in MASH-301 program.

NAS (NAFLD Activity Score) and Kleiner-Brunt fibrosis stage from central pathology read for MASH studies. Includes panel-of-three pathologist consensus where available.

Operationalized Hy's law definition: ALT or AST ≥ 3×ULN with total bilirubin ≥ 2×ULN and no other cause. Trigger for safety review per FDA DILI guidance.

Pro-C3, ELF score, FIB-4, NIS-4 serum biomarkers under exploratory evaluation as non-invasive MASH endpoints.