AASLD/EASL Endpoints for Clinical Trials: MetALD, ALD, MASLD, and Alpha-1 Antitrypsin Deficiency

Description

As the landscape of liver disease evolves, so too must our tools for evaluating therapeutic efficacy and disease progression.  This cutting-edge session will explore the latest advances and ongoing debates surrounding clinical trial and real-world endpoints for metabolic dysfunction-associated alcohol-related liver disease (MetALD), alcohol-associated liver disease (ALD), metabolic dysfunction-associated steatotic liver disease (MASLD), and alpha-1 antitrypsin deficiency (AATD). For MetALD, we will present the consensus endpoints developed by the AASLD/EASL MetALD Working Groups.  Experts will address the challenges of defining meaningful and harmonized endpoints across overlapping phenotypes, the role of biomarkers and imaging, and regulatory considerations in early- and late-phase trials. Emphasis will be placed on how to tailor endpoints to the unique pathophysiology of each disease while also considering patient-centered outcomes and emerging surrogate markers. This session is essential for clinicians, researchers, and industry stakeholders involved in trial design and drug development for liver diseases.