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Histological endpoints Histological endpoints to assess response to a therapeutic intervention can be broadly divided into those meeting a numerical reduction in one of two accepted scoring systems: NAFLD Activity Score (NAS) or Steatosis Activity and Fibrosis (SAF) score or the resolution of NASH as determined by a qualified hepatopathologist.[35], [36] When change in the NAS is used as a primary outcome, it is recommended that 2 point improvement in total score be achieved with contribution from multiple parameters of the NAS, alongside no worsening of fibrosis.37 For trials evaluating resolution of NASH, this is defined as a complete resolution of hepatocyte ballooning, with inflammation scores of 0 or 1, in addition to no worsening of fibrosis, though there is no specific requirement regarding change in steatosis

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