Much Awaited Cardiac Safety Data of Tirzepatide Released

Topline results from the SURPASS-CVOT trial reveal that once-weekly tirzepatide (Mounjaro) has a cardiovascular risk profile comparable to dulaglutide (Trulicity) in adults with type 2 diabetes and established atherosclerotic cardiovascular disease. Among over 13,000 participants, tirzepatide also showed additional benefits, including a 16% reduction in all-cause mortality, improved kidney function, better glycemic control, and greater weight loss over three years.

SURPASS-CVOT is the first head-to-head Phase 3 cardiovascular outcomes trial comparing two incretin therapies in adults with type 2 diabetes and established atherosclerotic cardiovascular disease. It was conducted in 30 countries spread over more than 4 years.The trial evaluated Mounjaro (tirzepatide), a dual GIP/GLP-1 receptor agonist, against Trulicity (dulaglutide), a GLP-1 receptor agonist previously shown to offer cardiovascular benefits in the REWIND study.

Mounjaro met the trial's primary endpoint by demonstrating non-inferiority to Trulicity in reducing major adverse cardiovascular events (MACE-3), including cardiovascular death, myocardial infarction, or stroke. Although not adjusted for multiplicity, Mounjaro also showed additional benefits, including improved A1C levels, greater weight loss, better renal function, and reduced all-cause mortality.

Cardiovascular disease remains the leading cause of death among people living with type 2 diabetes," said Kenneth Custer, Ph.D., executive vice president and president, Lilly Cardiometabolic Health. "The SURPASS-CVOT results show that Mounjaro preserved the cardioprotective benefit of Trulicity, a GLP-1 receptor agonist, while providing additional benefits, including greater kidney protection and a reduced overall risk of death. These findings strengthen the case for Mounjaro as a potential front-line treatment for people with type 2 diabetes and cardiovascular disease."

Complete findings from the SURPASS-CVOT trial will be presented at the European Association for the Study of Diabetes (EASD) annual meeting in September 2025 and subsequently published in a peer-reviewed journal.

Meanwhile, tirzepatide is also being evaluated in another large-scale cardiovascular outcomes trial, SURMOUNT-MMO. This study is assessing whether the drug can reduce the risk of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or heart failure events in individuals with overweight and either established cardiovascular disease or multiple age-related risk factors. Results from SURMOUNT-MMO are expected in 2027.