non alcoholic fatty liver disease
Liver disease clinical trials span a spectrum from non-alcoholic steatohepatitis (MASH/NASH) β€” where the FDA approved resmetirom in 2024 in a landmark first β€” to alcoholic hepatitis, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), autoimmune hepatitis, and hepatocellular carcinoma. MASH has become one of the most active areas in all of clinical medicine, driven by its rising global prevalence, progression to cirrhosis, and the now-validated principle that histological improvement is achievable.
Active MASH trials investigate THR-Ξ² agonists (resmetirom, MGL-3196), GLP-1/FGF21 combinations, FXR agonists, Pan-PPAR agonists (lanifibranor), and multi-target approaches combining metabolic and anti-fibrotic mechanisms. Hepatocellular carcinoma trials test atezolizumab plus bevacizumab combinations, lenvatinib plus pembrolizumab, and novel VEGF bispecifics. Liver fibrosis biomarkers (FIB-4, MRE-determined liver stiffness) are standard enrollment and response tools.
MASH trials typically require biopsy-confirmed NASH with fibrosis stage F1–F3 and NAS ≥4; end-stage liver disease (Child-Pugh C) is often an exclusion criterion.