The approval marks an important milestone for tirzepatide, making it the first dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist to receive an FDA label for cardiovascular risk reduction. Mounjaro was previously approved for glycemic management in patients with type 2 diabetes when used alongside lifestyle interventions such as diet and exercise.

Data From Head-to-Head Cardiovascular Outcomes Trial

The FDA decision was supported by findings from the SURPASS-CVOT study, a large international cardiovascular outcomes trial involving 13,299 participants across 30 countries. Conducted over more than 4.5 years, the study was notable for directly comparing two incretin-based therapies rather than evaluating a drug against placebo.

Researchers assessed tirzepatide against dulaglutide (Trulicity), another Lilly diabetes treatment with established cardiovascular benefits. Results showed that patients receiving Mounjaro experienced an 8% lower incidence of the composite endpoint of cardiovascular death, myocardial infarction, or stroke compared with those treated with Trulicity. Although the study demonstrated a reduction in major adverse cardiovascular events, it did not meet criteria to establish statistical superiority over dulaglutide.

The complete findings were published in The New England Journal of Medicine.

Addressing Cardiovascular Risk in Diabetes Care

Experts involved in the study emphasized the importance of cardiovascular prevention as a central component of diabetes management. While glucose control remains a key treatment objective, cardiovascular disease continues to be a leading cause of morbidity and mortality among patients with type 2 diabetes.

According to Lilly, an estimated one-third of U.S. adults living with type 2 diabetes may have cardiovascular disease that has not yet been diagnosed, highlighting the need for earlier risk identification and intervention.

Safety Profile Remains Consistent

The safety findings from SURPASS-CVOT were generally aligned with the established profile of tirzepatide. The most frequently reported adverse events were gastrointestinal, including symptoms typically associated with incretin therapies. These events were largely mild to moderate in severity and were most commonly observed during dose escalation.

Growing Competition in the Cardiometabolic Market

The expanded indication positions Mounjaro more directly against Novo Nordisk’s cardiometabolic portfolio. In recent years, Novo Nordisk has secured cardiovascular-related approvals for several of its GLP-1 therapies, including Wegovy for reducing cardiovascular risk in certain adults with overweight or obesity and established cardiovascular disease, as well as Rybelsus for lowering the risk of major cardiovascular events in people with diabetes.

Commercial Significance for Lilly

Mounjaro continues to be Eli Lilly’s leading product by revenue. The company reported second-quarter sales of approximately $9.9 billion for the therapy, reflecting year-over-year growth of 91%. Strong global demand has contributed to Lilly’s ongoing expansion, prompting the company to raise its full-year revenue guidance to between $85 billion and $87 billion.

With its newly approved cardiovascular indication, Mounjaro further strengthens its position in the increasingly competitive diabetes and cardiovascular disease treatment landscape, offering clinicians another evidence-based option for addressing both glycemic control and cardiovascular risk in high-risk patients with type 2 diabetes.