FDA Approves Mounjaro for Cardiovascular Risk Reduction in Type 2 Diabetes

• The FDA has approved Mounjaro to help reduce the risk of major cardiovascular events in people with type 2 diabetes who are at high risk.
• A major clinical trial found that Mounjaro performed as well as Trulicity for reducing the risk of heart attack, stroke, and cardiovascular death.
• People taking Mounjaro had an 8% lower relative risk of major cardiovascular events compared with those taking Trulicity.

On August 28, Eli Lilly, the manufacturer of Mounjaro (tirzepatide), announced that the Food and Drug Administration (FDA) approved the GLP-1 medication to help reduce cardiovascular risk in people with type 2 diabetes who are at high risk of cardiovascular events. 

The recent approval is for the reduction of major adverse cardiovascular events (MACE), which include: 

• non-fatal heart attack
• non-fatal stroke
• cardiovascular death

“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,” Kenneth Custer, PhD, executive vice president and president, Lilly Cardiometabolic Health, said in a press statement. 

Mounjaro may help reduce cardiovascular risk

The FDA approval was based on results from SURPASS-CVOT, the first cardiovascular outcomes trial to compare two GLP-1 medications head-to-head rather than against a placebo. 

SURPASS-CVOT was also the largest and longest tirzepatide study to date. It included more than 13,000 participants across 30 countries over a median follow-up of 4 years. 

Mounjaro was found to be noninferior to Trulicity (dulaglutide), a GLP-1 medication with an established cardiovascular benefit.

Major cardiovascular events occurred in 12.2% of participants taking Mounjaro compared with 13.1% of those taking Trulicity.

This represented an 8% lower relative risk of major cardiovascular events with Mounjaro compared with Trulicity.

“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,” Mir Ali, MD, medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, CA, who was not involved in the trial, told Healthline.  

“As we learn more about these medications, we are seeing that their effects may extend beyond blood sugar control and weight management,” he said. 

Mounjaro may help support heart health because it: 

• helps regulate blood sugar
• helps reduce blood pressure
• promotes weight loss
• improves cholesterol
• reduces inflammation

Randy Gould, DO, cardiologist with Manhattan Cardiology in NYC, who was also not involved in the trial, further explained how Mounjaro affects these areas. 

“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.

“The medication prevents high blood sugar spikes by signaling the pancreas to release insulin after eating, as well as slowing digestion to keep food in the stomach longer, leading to prolonged fullness and more consistent glucose absorption.” 

Gould added that these dual hormonal actions reduce systemic inflammation and endothelial dysfunction, which helps stabilize arterial plaques.

Ali noted that more research is needed to better understand whether Mounjaro has benefits that are independent of weight loss and improved diabetes control.

“Still, expanding our understanding of its potential effects could give healthcare providers additional tools to personalize treatment and optimize care for patients with diabetes and other related health risks,” he said. 

What does the FDA approval mean for type 2 diabetes? 

Rigved Tadwalkar, MD, consultative cardiologist and director of Digital Transformation at Pacific Heart Institute in Santa Monica, CA, who wasn’t involved in the trial, told Healthline that this gives clinicians another treatment option that can address several important problems at the same time for people with type 2 diabetes and elevated cardiovascular risk. 

“We are increasingly choosing diabetes therapies with an eye toward long-term outcomes, including heart attack, stroke, kidney disease, and heart failure, rather than focusing only on blood sugar,” he said. 

Tadwalkar added that clinicians have known that tirzepatide can improve blood sugar, promote substantial weight loss, and favorably affect several cardiometabolic risk factors. However, the FDA approval now recognizes cardiovascular event reduction as part of the drug’s clinical benefit.

Gould agreed and noted, “This additional indication might make it easier for patients to obtain their medication through their insurance carrier. It also means that physicians should choose Mounjaro over older or single-hormone treatments for diabetes, because of the added cardiovascular benefits.”

While the FDA approval is an encouraging step in the treatment of type 2 diabetes and cardiovascular disease, Tadwalkar told Healthline that he would emphasize that “the population studied was very high risk.”

“These were people with type 2 diabetes and established cardiovascular disease, so we should be careful about extending the same conclusions to every person taking tirzepatide,” he said.