Randomised clinical trial: Design of the SYNERGY‐NASH phase 2b trial to evaluate tirzepatide as a treatment for metabolic dysfunction‐associated steatohepatitis and modification of screening strategy to reduce screen failures
Raj Vuppalanchi,
Rohit Loomba,
Arun J. Sanyal
et al.
Abstract:SummaryBackgroundThe use of histological inclusion criteria for clinical trials of at‐risk metabolic dysfunction‐associated steatohepatitis (MASH) is often associated with high screen failure rates.AimsTo describe the design of a trial investigating tirzepatide treatment of MASH and to examine the effect of new inclusion criteria incorporating the use of the FibroScan‐AST (FAST) score on the proportion of patients meeting histological criteria.MethodsSYNERGY‐NASH is a Phase 2b, multicentre, randomised, double‐… Show more
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