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News
The FDA has approved Eli Lilly's Mounjaro (tirzepatide) to reduce the risk of heart attack, stroke, and cardiovascular death in adults with type 2 diabetes at high cardiovascular risk. It's the first dual GIP/GLP-1 receptor agonist to earn this indication, based on the landmark SURPASS-CVOT trial. Mounjaro showed an 8% lower rate of major adverse cardiovascular events compared to dulaglutide (Trulicity).
The FDA has officially approved Eli Lilly's Mounjaro (tirzepatide) to reduce the risk of major adverse cardiovascular events — including heart attack, stroke, and cardiovascular death — in adults with type 2 diabetes (T2D) who are at high cardiovascular risk. This makes tirzepatide the first dual GIP and GLP-1 receptor agonist to receive this indication, adding a meaningful new label to an already widely used drug.
The approval is grounded in results from the SURPASS-CVOT trial, a 5-year, randomized, double-blind Phase 3 study involving 13,299 participants across 30 countries. Tirzepatide was compared head-to-head against dulaglutide (Trulicity), a GLP-1 agonist with established cardiovascular benefits. The drug demonstrated noninferiority — and an 8% lower rate of MACE-3 events — though superiority over dulaglutide was not established. Safety was consistent with tirzepatide's known profile, with mostly mild-to-moderate GI side effects occurring primarily during dose escalation.
By the Numbers:
Why it matters: This approval expands Mounjaro's clinical utility beyond glucose control, giving clinicians a single agent that addresses both metabolic and cardiovascular risk in T2D patients — a population where heart disease remains a leading cause of death.
