Eli Lilly (United States)

Liver Fat Changes in Patients With Type 2 Diabetes by Presence of Genetic Hepatic Steatosis: A Post Hoc Analysis of SURPASS ‐3 MRI

ABSTRACT The patatin‐like phospholipase 3 (PNPLA3) I148M genetic variant is highly associated with steatotic liver disease. In the SURPASS‐3 MRI substudy, tirzepatide significantly reduced liver fat content (LFC) versus insulin degludec in insulin‐naïve patients with type 2 diabe...

BE-BOIN: A Dose Optimization Design Accommodating Backfill and Late-Onset Toxicity

The US Food and Drug Administration (FDA) launched Project Optimus and issued guidance to reform dose-finding and selection trials, shifting the paradigm from identifying the maximum tolerated dose (MTD) to determining the optimal biological dose (OBD), which optimizes the risk a...