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.

Surpassing expectations? The tirzepatide data so far
Trial name/ID Trial details Data (5mg dose)* Timing
Surpass-1 vs placebo in uncontrolled T2DM A1c -1.75%; weight loss 6.3kg Hit Dec 2020
Surpass-2 vs Ozempic + metformin in T2DM A1c -2.01%; weight loss 7.6kg Hit Mar 2021
Surpass-3 vs Tresiba in T2DM A1c -1.85%; weight loss 7.0kg Hit Feb 2021
Surpass-4 vs insulin glargine in pts with T2DM & increased CV risk A1c -2.11%; weight loss 6.4kg Hit May 2021
Surpass-5 vs placebo in T2D inadequately controlled with insulin glargine +/- metformin A1c -2.11%; weight loss 5.4kg  Hit Feb 2021
Surpass-6 vs Humalog in T2DM inadequately controlled with insulin glargine +/- metformin - Completes Aug 2022
Surpass-CVOT vs Trulicity on major CV events in T2DM pts - Completes Oct 2024
*Treatment-regimen estimand. Source: Lilly releases.

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