The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s Mounjaro (tirzepatide) to reduce the risk of major adverse cardiovascular events, including cardiovascular death, heart attack and stroke, in adults with type 2 diabetes who are at high risk of such events.
The approval is based on findings from a cardiovascular outcomes study that compared Mounjaro directly with Lilly’s older diabetes treatment, Trulicity. According to the trial results, Mounjaro showed a lower rate of cardiovascular death, heart attack and stroke than Trulicity.
Approval Supported by Results From SURPASS-CVOT Study
The FDA decision was supported by data from the phase 3 SURPASS-CVOT study, which enrolled approximately 13,000 patients across 30 countries and continued for more than four years.
In the trial, Mounjaro was evaluated against Trulicity, a GLP-1 diabetes medicine that received approval for type 2 diabetes in 2014 and later gained an indication to reduce cardiovascular disease risk in 2020. The study found that Mounjaro resulted in an 8% lower rate of major adverse cardiovascular events than Trulicity.
Lilly said the approval was achieved through the first head-to-head cardiovascular outcomes trial between two incretin medicines rather than through a placebo-controlled study.
Commenting on the trial, Kenneth Custer, Ph.D., Lilly’s head of Cardiometabolic Health, said: “We set a higher bar by testing Mounjaro against a GLP-1 medicine with proven cardiovascular benefit, one that reflects the depth of evidence Lilly continues to build in this field.”
First Label Expansion for Mounjaro
The cardiovascular indication represents the first label expansion for Mounjaro since the FDA initially approved the medicine four years ago.
Lilly said that one in every three people with type 2 diabetes also has undetected cardiovascular disease.
Mounjaro is Lilly’s diabetes drug that targets the GLP-1 protein and is also used for weight loss. In the United States, the obesity version is marketed as Zepbound. In 2024, Zepbound, which contains the same compound, tirzepatide, received an expanded indication for sleep apnea.
Similar Cardiovascular Label Expansion to Ozempic
The approval gives Mounjaro a cardiovascular risk-reduction indication similar to the one Novo Nordisk received for Ozempic in 2020.
The two companies reached these milestones on comparable timelines. Ozempic obtained its cardiovascular indication three years after its initial FDA approval, while Mounjaro secured its expanded indication four years after its original approval.
Novo Nordisk has also received additional FDA approvals related to cardiovascular risk. Wegovy, its obesity treatment, was approved in 2024 to lower cardiovascular risk in adults who are overweight or obese without diabetes. In 2025, the FDA approved Rybelsus to reduce major cardiovascular risks in people with diabetes.
That same year, Ozempic received approval to reduce the risk of kidney disease and cardiovascular death in patients with type 2 diabetes and chronic kidney disease. Wegovy also gained approval for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).
Mounjaro Sales Increased During the Second Quarter
Lilly reported that second-quarter sales of Mounjaro rose 91% to $9.94 billion. The company said strong demand increased sales volumes across global markets.
With the FDA decision, Mounjaro is approved to reduce the risk of major adverse cardiovascular events, including cardiovascular death, heart attack, and stroke, in adults with type 2 diabetes who are at elevated cardiovascular risk.
Eli Lilly’s Mounjaro (tirzepatide) has received U.S. FDA approval to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who are at high risk. The expanded indication covers cardiovascular death, non-fatal heart attack, and non-fatal stroke.
The decision expands the role of the medicine beyond blood-sugar management and adds another cardiovascular benefit to its established effects on A1C and body weight.
Eli Lilly’s Mounjaro and Cardiovascular Risk
Eli Lilly’s Mounjaro is a dual GIP and GLP-1 receptor agonist. The new indication is based on results from the SURPASS-CVOT cardiovascular outcomes trial, which compared tirzepatide with dulaglutide, marketed as Trulicity.
Eli Lilly’s Strong Commercial Performance
The regulatory expansion comes as Mounjaro continues to generate substantial sales. Reuters reported that Mounjaro sales increased 91% year over year to $9.94 billion in the second quarter of 2026, reflecting strong global demand.
The cardiovascular indication could provide another important growth opportunity as physicians and patients consider treatments that address multiple aspects of cardiometabolic health.
Eli Lilly’s Future Cardiometabolic Strategy
Eli Lilly’s broader pipeline includes additional medicines being evaluated for cardiovascular and metabolic outcomes. The company is also studying its oral obesity candidate and next-generation therapies in late-stage cardiovascular and kidney-related research.
These programs indicate that the company is pursuing a wider cardiometabolic strategy rather than focusing solely on blood-glucose reduction or weight management.
Eli Lilly’s Impact on Diabetes Care
The FDA decision could encourage greater attention to cardiovascular risk when selecting therapies for appropriate adults with type 2 diabetes. Heart disease remains a major concern for people living with diabetes, making cardiovascular outcomes an important consideration in treatment development.
For Eli Lilly’s Mounjaro, the expanded indication represents a significant milestone that connects diabetes management with cardiovascular risk reduction.
Eli Lilly’s Expanding Mounjaro Opportunity
Eli Lilly’s Mounjaro has already become a major diabetes product, and the cardiovascular indication could further strengthen its position in the expanding GLP-1 and GIP treatment market.
The approval also reflects a broader industry trend in which metabolic medicines are being studied for benefits beyond glucose control and weight management.
Eli Lilly’s Dual GIP and GLP-1 Approach
Mounjaro contains tirzepatide, which activates both GIP and GLP-1 receptors. This mechanism supports glucose regulation and weight reduction while the latest approval recognizes its ability to lower major cardiovascular event risk in a specific high-risk diabetes population.
Eli Lilly’s Competition in the GLP-1 Market
Eli Lilly’s expanded indication places Mounjaro more directly into competition with cardiovascular indications held by other GLP-1 medicines.
Cardiovascular Benefits Beyond Blood Sugar Control
The latest regulatory decision expands the role of tirzepatide in diabetes management. The medicine can now be used to reduce the risk of major cardiovascular events in adults with type 2 diabetes who are considered at high risk. These events include cardiovascular death, non-fatal heart attack, and non-fatal stroke.
Results From SURPASS-CVOT
The approval was supported by the SURPASS-CVOT Phase 3 trial, which enrolled 13,299 participants across 640 sites in 30 countries. Participants were followed for a median of about four years.
The study compared tirzepatide with dulaglutide, a GLP-1 medicine with established cardiovascular benefits. Tirzepatide demonstrated non-inferiority, with an 8% lower rate of cardiovascular death, heart attack, or stroke compared with dulaglutide.
Implications for Diabetes Treatment
Cardiovascular disease is a major concern for people living with type 2 diabetes. Having evidence from a large cardiovascular outcomes trial could influence how clinicians evaluate treatment options for patients who have elevated cardiovascular risk.
The expanded indication also demonstrates how newer metabolic medicines are increasingly being evaluated for outcomes beyond glucose reduction and weight management.
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