The Food and Drug Administration has approved Mounjaro, the diabetes drug made by Eli Lilly, to reduce the risk of major cardiovascular events in people with type 2 diabetes who are at high cardiovascular risk. The company announced the approval on August 28.
The approved indication covers three specific outcomes: non-fatal heart attack, non-fatal stroke, and cardiovascular death. For people managing type 2 diabetes, those outcomes represent the most serious consequences of the disease. Heart disease is already the leading cause of death among that population.
"For people with type 2 diabetes, heart disease is the leading cause of death, and Mounjaro … now gives them a proven way to lower that risk, adding to the strong foundation it has already built in A1C and weight," said Kenneth Custer, PhD, executive vice president and president of Lilly Cardiometabolic Health, in a press statement.
The FDA based its decision on results from a trial called SURPASS-CVOT, which Healthline described as the first cardiovascular outcomes trial to compare two GLP-1 medications directly against each other rather than against a placebo. The trial included more than 13,000 participants in 30 countries and had a median follow-up of four years, making it the largest and longest tirzepatide study conducted to date.
Mounjaro was compared against Trulicity, a GLP-1 drug with an already-established cardiovascular benefit. Major cardiovascular events occurred in 12.2% of participants taking Mounjaro compared with 13.1% of those taking Trulicity. That translated to an 8% lower relative risk of major cardiovascular events for Mounjaro.
Doctors not involved in the trial weighed in on the findings. Mir Ali, MD, medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, California, said the results pointed to benefits that go beyond what Mounjaro was already known for. "My first reaction is that this is encouraging news because it suggests Mounjaro may offer important health benefits beyond its established role in managing type 2 diabetes and supporting weight loss," he told Healthline.
He added: "As we learn more about these medications, we are seeing that their effects may extend beyond blood sugar control and weight management."
Randy Gould, DO, a cardiologist with Manhattan Cardiology in New York City, explained how the drug works at a mechanical level. "Mounjaro is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist. It lowers blood sugar by increasing metabolic processing and reducing fat accumulation in the liver," he said.
Beyond blood sugar, Mounjaro is associated with reductions in blood pressure, improvements in cholesterol, weight loss, and reduced inflammation, all of which can affect cardiovascular risk over time.
