By Dr. Asnat Raziel, bariatric surgeon specializing in obesity treatment, metabolic health and healthy longevity; Director of the Multidisciplinary Center for Obesity Treatment, Assia Medical, Assuta Ramat HaChayal, Tel Aviv
If you live with diabetes and heart disease, the key question is not only how far your blood sugar drops. It is also whether your treatment protects your heart. In this article, I focus on the practical side: who the new Mounjaro approval applies to, what you can expect from it compared with Trulicity, and what to ask your doctor.
Diabetes and heart disease: what changed with the Mounjaro approval?
In August 2026, the link between Mounjaro and heart protection received an official seal. Mounjaro, whose active ingredient is tirzepatide, is one of the most important drugs for type 2 diabetes and obesity. On August 28, 2026, the U.S. Food and Drug Administration approved an expanded indication. As a result, the drug is now also approved to reduce the risk of major cardiac events in high-risk adults with type 2 diabetes.
The new indication covers a lower risk of death from cardiovascular disease, nonfatal heart attack and nonfatal stroke. In other words, we can look at Mounjaro not only through the lens of weight or blood sugar. Instead, it becomes part of a comprehensive approach to cardiometabolic risk.
Who took part in the trial: people with diabetes and heart disease
The approval is based on the SURPASS-CVOT trial, published in December 2025 in the New England Journal of Medicine. The trial enrolled 13,299 patients with type 2 diabetes and established atherosclerotic cardiovascular disease. Their average age was about 64. Their average BMI (body mass index, weight relative to height) was 32.6. In addition, their HbA1c, a measure of average blood sugar over the past three months, was 8.4%. On average, they had lived with diabetes for almost 15 years.
The trial ran at 640 centers in 30 countries, and median follow-up lasted about four years. However, the most interesting detail of the trial is actually the comparison group.
Mounjaro vs Trulicity: a comparison with a drug that already protects the heart
The researchers did not compare Mounjaro with a placebo. Instead, they chose a serious rival: Trulicity (dulaglutide), at a dose of 1.5 mg once a week. Trulicity is a GLP-1 drug that has already shown a benefit for the heart. The other group received tirzepatide up to 15 mg a week, or the highest dose each patient could tolerate.
So this was a high bar. The question was not whether Mounjaro beats “nothing.” Rather, the question was how it performs against a treatment that already protects the heart.
8% fewer events: what it means for patients
The trial’s primary endpoint was MACE-3, a combination of three events: cardiovascular death, heart attack or stroke. Such an event occurred in 12.2% of patients on tirzepatide. By contrast, it occurred in 13.1% of the dulaglutide group. The hazard ratio was 0.92, which means a relative reduction of about 8%.
Still, precision matters here. The researchers designed the trial first to show that tirzepatide is not inferior to dulaglutide, and they met that goal. On the other hand, the 8% advantage was not enough to prove superiority. The confidence interval was 0.83 to 1.01, and the P value for superiority was 0.09. Therefore, it is not accurate to say that Mounjaro has been proven better than Trulicity. It is accurate to say that it protects the heart at least as well as a proven drug, with a numerical trend in its favor.
Mortality, weight and side effects
This is where an interesting figure appears. According to a summary of the trial results, all-cause death was 8.6% in the Mounjaro group, compared with 10.2% in the Trulicity group. The hazard ratio was 0.84, a relative reduction of about 16%. However, this was a secondary endpoint. Moreover, the FDA indication covers a reduction in major cardiac events, not a reduction in all-cause death.
In the trial, weight fell by 11.6% with tirzepatide, compared with 4.5% with dulaglutide. HbA1c also dropped sharply. On the other hand, 13.2% of patients on Mounjaro stopped treatment because of side effects, compared with 10.1% on Trulicity. Most of these side effects were digestive.
Diabetes and heart disease: do these results apply to me?
First, it is worth checking how closely you resemble the people in the trial. They were adults with type 2 diabetes and established atherosclerotic cardiovascular disease. Their average age was about 64, and their average BMI was 32.6. In addition, their average HbA1c was 8.4%, and they had lived with diabetes for almost 15 years on average. If that describes you, these data speak to you directly.
In your conversation with your doctor, three questions are worth asking. First, has your current treatment been shown to protect the heart? Second, what could Mounjaro add for you, beyond lower blood sugar and weight? Third, how will you handle digestive side effects, which led 13.2% of trial participants to stop treatment? Also keep in mind that the approval does not cover obesity without diabetes. I analyze what the FDA approval does and doesn’t say in a separate article. I also cover the trial itself in more depth in my article on the SURPASS-CVOT results.
Diabetes and heart disease: treatment is no longer measured by blood sugar alone
The approval reflects a deep shift in how we treat type 2 diabetes. For years, the main goal was to lower blood sugar and HbA1c. Today, it is clear that this is only part of the story.
Type 2 diabetes is linked to obesity, belly fat, high blood pressure, blood lipids, kidney disease and atherosclerosis. That is why the important question is whether a treatment reduces the diseases that harm quality of life and life expectancy. I wrote about this connection at length in my article on cardiovascular-kidney-metabolic syndrome. Mounjaro acts on two receptors, GIP and GLP-1. According to the manufacturer, it is the first drug of its kind proven to reduce the risk of heart attack and stroke in this population.
Mounjaro and Zepbound: exactly who the approval covers
In the United States, tirzepatide is sold under two names. Mounjaro is intended for type 2 diabetes, while Zepbound is intended for obesity. In Europe and Israel, the name Mounjaro is used for both purposes. The new FDA approval refers to adults with type 2 diabetes at high cardiac risk.
Therefore, we cannot conclude from this approval that the same indication now applies to everyone with obesity but without diabetes. The SURMOUNT-MMO trial is examining that question. It is testing the effect of tirzepatide on illness and death in people with obesity. For full information about the drug, see my complete guide to Mounjaro.
The competition is moving from weight to the heart
This approval is part of a broader race between drug companies. Back in March 2024, the FDA approved Wegovy to reduce cardiac risk in adults with heart disease and obesity or overweight. That approval was based on the SELECT trial. In October 2025, Rybelsus (oral semaglutide) also received a similar cardiac indication in diabetes.
Now Mounjaro officially joins the field. This means the competition is no longer only about kilograms or HbA1c. Instead, the measure that matters is which drug prevents disease and keeps people healthy over time.
What is coming next?
Lilly’s pipeline is also worth watching. Foundayo (orforglipron) is a daily GLP-1 pill. The FDA approved it on April 1, 2026, for the treatment of obesity. In the ACHIEVE-4 trial, researchers compared it with insulin glargine in people with type 2 diabetes, overweight and cardiac risk. The drug met its goal of non-inferiority for heart safety, but it is not yet approved for diabetes. You can read more in my guide to Foundayo treatment.
At the same time, retatrutide is moving forward. This drug acts on three receptors: GIP, GLP-1 and glucagon. The TRIUMPH trials are testing not only weight loss, but also heart and kidney outcomes. The drug is not yet approved.
Diabetes and heart disease through the lens of longevity
This development fits well with the concept of longevity and metabolic health. Weight loss is important, but it is not the final goal. The goal is to reduce belly fat, improve blood pressure and blood lipids, and preserve muscle and bone. In addition, we want to reduce diabetes, heart disease, stroke and kidney disease over the years. You can find real-world data on the drug and the heart in my article on Mounjaro and the heart in the real world.
Ultimately, the important question is not how many kilograms a patient has lost. The question is whether that patient will stay healthy over time. The data on Mounjaro and cardiovascular risk are another step in that direction.
Questions and answers
What exactly did the FDA approve for Mounjaro?
The FDA approved Mounjaro to reduce the risk of major cardiac events: cardiovascular death, nonfatal heart attack or nonfatal stroke. The approval applies to high-risk adults with type 2 diabetes.
Did Mounjaro lower the risk more than Trulicity?
The Mounjaro group had about 8% fewer events. However, the difference did not reach the statistical significance needed to prove superiority. The trial proved non-inferiority to Trulicity.
Does the approval also apply to people with obesity but no diabetes?
No. The approval refers to high-risk adults with type 2 diabetes. The SURMOUNT-MMO trial is examining the question in people with obesity without diabetes.
Are Mounjaro and Zepbound the same drug?
Yes, both contain the active ingredient tirzepatide. In the United States, Mounjaro is marketed for type 2 diabetes, and Zepbound for obesity and other indications.
What is the key message of the new approval?
Modern treatment of diabetes and obesity goes beyond blood sugar and weight. The goal is to reduce chronic disease and add healthy years of life.
The information in this article is general and does not replace personal medical advice.
References
Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes
The SURPASS-CVOT and ACHIEVE-4 trials were funded by Eli Lilly, the maker of Mounjaro and Foundayo.
