Lilly’s tirzepatide heads to the regulators

Lilly will submit its dual GIP/GLP-1 agonist tirzepatide to regulators by the end of 2021 after the project scored today in its fifth pivotal trial, Surpass-4. The study, in type 2 diabetes patients with increased cardiovascular risk, found tirzepatide was superior to insulin glargine on HbA1c and weight loss. More importantly, it helped demonstrate tirzepatide’s cardiovascular safety, a requirement for type 2 diabetes drugs. A meta-analysis of the Surpass programme found a 19% relative risk reduction in major cardiovascular events with tirzepatide versus pooled comparator data; Surpass-4 accounted for the majority of these events. The go-to dose of tirzepatide will be 5mg, Lilly’s chief scientific officer, Daniel Skovronsky, said during the group’s first-quarter call, with the option to dose higher. If approved, tirzepatide will become the latest weapon in Lilly’s battle with Novo Nordisk in diabetes; the Danish group ditched a glucagon/GLP-1 co-agonist and a glucagon, GLP-1 and GIP tri-agonist last year, citing toxicity concerns. Lilly has its own tri-agonist, “triple G”, which it has said could be even better than tirzepatide. Phase 1 data with this project, as well as results from Surpass-1, 2, 3 and 5, will feature at next month’s ADA meeting.