MASH (metabolic dysfunction-associated steatohepatitis) presents unique challenges in clinical trial design because liver biopsy is costly, invasive, and slow to reflect change. To address this, non-invasive tests (NITs) are increasingly integrated into MASH drug development to support proof-of-mechanism, inform dose selection, and enable early efficacy assessment, with the potential to accelerate regulatory decision-making.
Drawing on a comparative analysis of 14 interventional studies, our poster (presented at the 2026 SOLAR Conference (Steatosis, Obesity, and Liver Disease Advances in Clinical Research)) shows that NITs offer a multimodal strategy for detecting early pharmacodynamic activity and characterizing dose-response in MASH. The findings support combining imaging, serum biomarkers, and composite indices to strengthen interpretation of pharmacodynamic effects and early efficacy signals, reducing reliance on biopsy without compromising decision quality.
Read our poster for a comprehensive overview of NIT performance across therapeutic classes, endpoint strategies, and practical guidance for integrating non-invasive assessment into MASH development programs for sponsors and trial teams.
