Amended analysis plan
NASH
Because of unexpected histological findings in a concurrent phase 2 study of seladelpar in patients with NASH, dosing in ENHANCE was interrupted on November 25, 2019, and the study was terminated prematurely on December 20, 2019. The biopsy tissues and full clinical profile of each patient in the NASH trial were reviewed by an independent committee of pathologists and hepatologists who concluded that the histological features of concern were also observed in baseline biopsies and were unrelated to seladelpar treatment.