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Rachel V Thomas

US FDA Approves Eli Lilly’s Mounjaro To Reduce Cardiovascular Risk In Diabetics

The US Food and Drug Administration (<span>FDA</span>) has approved <span>Eli Lilly</span>’s <span>Mounjaro</span> (<span>tirzepatide</span>), typically used to control Type 2 <span><a href="https://www.healthandme.com/health/diabetes">diabetes</a></span>, to also reduce the risk of heart attack or stroke, the American drug maker said.

Mounjaro is already approved as an adjunct to diet and exercise to improve blood sugar in adults and children aged 10 and older with Type 2 diabetes. It targets the GLP-1 protein and is also used for weight loss. In the US, the obesity version is sold under the brand name Zepbound.

<h2>Mounjaro: What Cardiovascular Risks Can It Reduce?</h2>

The FDA approved Mounjaro to lower the risk of major adverse cardiovascular events (MACE), including:

<ul><li>Cardiovascular death</li><li>Non-fatal heart attack</li><li>Non-fatal stroke</li></ul>

<strong>Also read: </strong><a href="https://www.healthandme.com/health-news/uk-woman-dies-after-sudden-abdominal-pain-following-increase-in-her-mounjaro-dose-article-155291607" data-type="tilCustomLink">UK Woman Dies After Sudden Abdominal Pain Following Increase In Her Mounjaro Dose</a>

The approval applies to adults with Type 2 diabetes who are at high risk for these events.

“For people with Type 2 diabetes, heart disease is the leading cause of death, and Mounjaro – the number 1 most prescribed branded Type 2 diabetes medicine for adults in the US – 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, executive vice president and president, Lilly Cardiometabolic Health.

The FDA approval was based on results from a trial that showed Mounjaro outperformed Trulicity, Lilly’s older diabetes drug, in reducing the risk of heart attack and stroke in a large, head-to-head study.

The trial showed that Mounjaro reduced the risk of major adverse cardiovascular events by 8% more than Trulicity.

It was the largest and longest tirzepatide study to date, enrolling more than 13,000 participants across 30 countries over more than four and a half years.

The most commonly reported adverse events in SURPASS-CVOT for Mounjaro were gastrointestinal-related, generally mild to moderate in severity, and occurred primarily during the dose-escalation period.

<h2>What About <span rel="noindex">Novo Nordisk</span>’s Drugs?</h2>

Read More: <a href="https://www.healthandme.com/health-news/glp-1-weight-loss-drugs-ozempic-wegovy-mounjaro-tied-to-over-60-reported-deaths-in-australia-article-155621346" data-type="tilCustomLink">GLP-1 Weight Loss Drugs Ozempic, Wegovy, Mounjaro Tied To Over 60 Reported Deaths In Australia</a>

“Mounjaro is the first and only GIP and GLP-1 receptor agonist proven to lower heart attack, stroke or cardiovascular death risk in adults with Type 2 diabetes at high risk for these events – in addition to its established A1C and weight loss benefits,” according to Lilly.

However, Danish rival Novo Nordisk secured FDA approval for its weight-loss drug Wegovy to lower heart risks in 2024 in overweight or obese adults without diabetes.

In 2025, the FDA also approved its older diabetes drug, Rybelsus, to reduce the risk of major adverse cardiovascular events in diabetic patients.

Mounjaro is a brand name for tirzepatide, an injectable weekly treatment first approved by the US FDA for the control of Type 2 diabetes.

Unlike older weight-loss drugs that act on metabolism or suppress appetite as their primary mechanism, Mounjaro acts on two key hormones: GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide). These control the release of insulin and sensations of fullness.

By mimicking their action, Mounjaro decreases hunger and enhances blood sugar control — two key obstacles in successful weight maintenance.

The key to Mounjaro’s success is tirzepatide, a dual-acting peptide that acts on receptors in the brain and stomach. When taken, it sets in motion a chain reaction of signals that tell the brain that you are full, helping reduce cravings and overeating.

Mounjaro also makes the body more responsive to insulin. In people with obesity, insulin resistance is frequent and can make weight loss more difficult. By enhancing insulin action, Mounjaro helps the body better control blood sugar and store less fat. In a sense, Mounjaro doesn’t simply allow you to eat less — it allows your body to use what you eat more efficiently.

Health Conditions A-Z

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Eli Lilly

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Mounjaro

GLP 1

tirzepatide

diabetes

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The US Food and Drug Administration (FDA) has approved Eli Lilly’s Mounjaro (tirzepatide), typically used to control Type 2 diabetes, to also reduce the risk of heart attack or stroke, the American drug maker said.Mounjaro is already approved as an adjunct to diet and exercise to improve blood sugar in adults and children aged 10 and older with Type 2 diabetes. It targets the GLP-1 protein and is also used for weight loss. In the US, the obesity version is sold under the brand name Zepbound.Mounjaro: What Cardiovascular Risks Can It Reduce?The FDA approved Mounjaro to lower the risk of major adverse cardiovascular events (MACE), including:Cardiovascular deathNon-fatal heart attackNon-fatal strokeAlso read: UK Woman Dies After Sudden Abdominal Pain Following Increase In Her Mounjaro DoseThe approval applies to adults with Type 2 diabetes who are at high risk for these events.“For people with Type 2 diabetes, heart disease is the leading cause of death, and Mounjaro – the number 1 most prescribed branded Type 2 diabetes medicine for adults in the US – 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, executive vice president and president, Lilly Cardiometabolic Health.How Was Mounjaro Approved?The FDA approval was based on results from a trial that showed Mounjaro outperformed Trulicity, Lilly’s older diabetes drug, in reducing the risk of heart attack and stroke in a large, head-to-head study.The trial showed that Mounjaro reduced the risk of major adverse cardiovascular events by 8% more than Trulicity.It was the largest and longest tirzepatide study to date, enrolling more than 13,000 participants across 30 countries over more than four and a half years.The most commonly reported adverse events in SURPASS-CVOT for Mounjaro were gastrointestinal-related, generally mild to moderate in severity, and occurred primarily during the dose-escalation period.What About Novo Nordisk’s Drugs?Read More: GLP-1 Weight Loss Drugs Ozempic, Wegovy, Mounjaro Tied To Over 60 Reported Deaths In Australia“Mounjaro is the first and only GIP and GLP-1 receptor agonist proven to lower heart attack, stroke or cardiovascular death risk in adults with Type 2 diabetes at high risk for these events – in addition to its established A1C and weight loss benefits,” according to Lilly.However, Danish rival Novo Nordisk secured FDA approval for its weight-loss drug Wegovy to lower heart risks in 2024 in overweight or obese adults without diabetes.In 2025, the FDA also approved its older diabetes drug, Rybelsus, to reduce the risk of major adverse cardiovascular events in diabetic patients.What Is Mounjaro?Mounjaro is a brand name for tirzepatide, an injectable weekly treatment first approved by the US FDA for the control of Type 2 diabetes. Unlike older weight-loss drugs that act on metabolism or suppress appetite as their primary mechanism, Mounjaro acts on two key hormones: GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide). These control the release of insulin and sensations of fullness.By mimicking their action, Mounjaro decreases hunger and enhances blood sugar control — two key obstacles in successful weight maintenance.How Does Mounjaro Work?The key to Mounjaro’s success is tirzepatide, a dual-acting peptide that acts on receptors in the brain and stomach. When taken, it sets in motion a chain reaction of signals that tell the brain that you are full, helping reduce cravings and overeating.Mounjaro also makes the body more responsive to insulin. In people with obesity, insulin resistance is frequent and can make weight loss more difficult. By enhancing insulin action, Mounjaro helps the body better control blood sugar and store less fat. In a sense, Mounjaro doesn’t simply allow you to eat less — it allows your body to use what you eat more efficiently.

us fda approves eli lilly’s mounjaro to reduce cardiovascular risk in diabetics

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