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# FDA OKs Lilly's Mounjaro to Reduce CV Risk in Adults with Diabetes
- URL: https://www.fdaweb.com/fda-oks-lillys-mounjaro-to-reduce-cv-risk-in-adults-with-diabetes/
- Published: 2026-08-28T12:00:00.000Z
- Updated: 2026-09-14T12:05:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161702

FDA has approved Eli Lilly’s Mounjaro (tirzepatide) for lowering the risk of major adverse cardiovascular (CV) events (MACE), including CV death, non-fatal heart attack, or non-fatal stroke in adults with Type 2 diabetes who are at high risk for such events. The dual GIP and GLP-1 hormone receptor agonist is currently approved as an adjunct to diet and exercise to improve blood sugar in adults and children 10 years of age and older with Type 2 diabetes.

Approval was based on data from SURPASS-CVOT, “the first cardiovascular outcomes trial comparing two incretin medicines head-to-head rather than against a placebo, and the largest and longest tirzepatide study to date, enrolling more than 13,000 participants across 30 countries over more than four and a half years,” the [company says](https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-mounjaro-tirzepatide-reduce-cardiovascular?ref=fdaweb.com).

In the trial, Mounjaro demonstrated non-inferiority to Lilly’s Trulicity (dulaglutide), a GLP-1 treatment with established cardiovascular benefit, with an 8% lower rate of cardiovascular death, heart attack or stroke (MACE-3), it says.