Outcomes and potential surrogate markers for future clinical trials of non‐alcoholic steatohepatitis cirrhosis

Non-alcoholic steatohepatitis has emerged as a major public health problem, and the burden of non-alcoholic cirrhosis is projected to increase by 64%-156% 2030. The threat aggravated fact that are currently no approved drugs for treatment steatohepatitis. In this paper, we review main challenges drug development in patients with cirrhosis, describe opportunities brought advances understanding clinical pathophysiological nuances cirrhosis. design therapeutic regimens will vary according specific substage (compensated vs decompensated), mechanistic basis therapy, targeted either at improving aetiology-specific pathways and/or more general aetiology-agnostic processes. probabilistic expectations whole range potential outcomes, rooted different drivers each substage, be essential order choose adequate estimands strategies trials individual Finally, provide summary pitfalls uncertainties discuss biomarkers use practice these patients.