Endpoints
non-alcoholic fatty liver disease, NAFLD, fatty liver disease, fibrosis, NASH-related
LIVER FIBROSIS, FIBROSIS, NON-ALCOHOLIC FATTY LIVER DISEASE
The primary endpoint was the absolute change in HbAPharmacodynamic endpoints were the changes from baseline in exploratory biomarkers related to liver function and fatty liver disease (plasma levels of cytokeratin 18 and Pro-C3 and enhanced liver fibrosis [ELF] score), glucose metabolism (adiponectin and fasting insulin and C-peptide levels) and target receptor engagement (amino acid and glucagon levels). Exploratory NASH-related scores (Fibrosis-4 [Fib-4] score, aspartate aminotransferase/platelet ratio [APRI] and non-alcoholic fatty liver disease [NAFLD] fibrosis score) were assessed as safety-related endpoints.The attainment of steady state and dose proportionality of survodutide were assessed as pharmacokinetic endpoints.