New indication for tirzepatide use

Eli Lilly has announced that the U.S. regulatory agency FDA has approved an expansion of the use of the drug Mounjaro (tirzepatide).  Previously, the medication was intended only for the treatment of type 2 diabetes; now it is officially approved for the prevention of cardiovascular complications — heart attacks and strokes.  The approval is based on data from the four‑year SURPASS‑CVOT study, which involved 13,000 participants. In the study, the efficacy of tirzepatide was compared with the results of dulaglutide (Trulicity), which already has similar indications for use.

The comparative analysis showed that tirzepatide and dulaglutide demonstrate comparable rates of preventing cardiovascular events (12 % vs. 13 %). At the same time, therapy with tirzepatide is associated with a lower risk of overall mortality (16 % lower).

The superiority of tirzepatide is due to its dual mechanism of action on the receptors of glucose‑dependent insulinotropic polypeptide (GIP) and glucagon‑like peptide‑1 (GLP‑1), which makes it a more effective tool for correcting metabolic disorders compared to drugs of the previous generation. Since its regulatory approval in 2022–2024, the range of applications for the molecule has expanded from type 2 diabetes to the treatment of obesity and apnea.

In a third of people with diabetes, cardiovascular pathologies develop in a latent form. Constantly elevated blood sugar levels damage the vascular system, triggering atherosclerosis, which is often diagnosed too late — after critical events such as a heart attack.

Since 2020, in the USA, the drug Ozempic (semaglutide) from Novo Nordisk has been officially used to reduce cardiovascular risks. According to the results of the Sustain 6 study, the therapy reduced the likelihood of heart attack, stroke, and death from heart disease by 26 % compared to placebo.

The competition between Novo Nordisk and Eli Lilly has extended far beyond the treatment of diabetes and obesity. In 2025, semaglutide received approval for the treatment of chronic kidney disease (CKD) and steatohepatitis (MASH), and is also being tested for its effectiveness in treating alcoholism, heart failure, and other diseases. In turn, Eli Lilly is testing its drug tirzepatide in similar areas, including CKD, inflammatory bowel diseases, and osteoarthritis.