NAFLD and NASH biomarker qualification in the LITMUS consortium – Lessons learned

This review distills LITMUS lessons on biomarker qualification to speed NAFLD/NASH drug development. cT1 (LiverMultiScan) was submitted to EMA/FDA for prognostic enrichment and now holds an FDA-accepted Biomarker Qualification Program, the first for a diagnostic enrichment biomarker in NASH trials, positioning cT1 to streamline recruitment and improve trial success.