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In August 2026, the U.S. FDA approved tirzepatide (Mounjaro) to reduce the risk of major adverse cardiovascular events among adults with type 2 diabetes who are at high risk for such events. Tirzepatide activates both glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide receptors. It is now the fourth GLP-1 agonist with a cardiovascular risk-reduction indication, joining dulaglutide, semaglutide, and liraglutide.
The approval was based on an industry-funded, randomized, double-blind trial comparing tirzepatide with dulaglutide among 13,000 patients with type 2 diabetes and established atherosclerotic cardiovascular disease (mean age, 64; BMI, 33 kg/m2; hemoglobin A1c, 8.4%; diabetes duration, 15 yea…