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Help Research the Impact of Tirzepatide on Heart Health

Do you have type 2 diabetes and heart disease? In this clinical trial called SURPASS-CVOT, researchers are studying the use of tirzepatide, a new glucose lowering therapy in clinical trials for people with type 2 diabetes, in preventing heart disease complications. Learn more about how to get involved below.

Clinical Trials Identifier: NCT04255433

Trial Name: A Study of Tirzepatide Compared with Dulaglutide on Major Cardiovascular Events in Participants with Type 2 Diabetes (SURPASS-CVOT)

Diabetes Type: Type 2

What is the trial testing?

The SURPASS-CVOT trial is comparing two different glucose-lowering medicines, tirzepatide (an experimental medicine) and Trulicity (dulaglutide), on their ability to effectively and safely treat people with type 2 diabetes who also  have an increased risk of heart complications. While Trulicity is already used in people with type 2 diabetes and has demonstrated heart health benefits, this study is evaluating which therapy has greater results for preventing heart disease complications.

In this 54-month study, an estimated 12,500 participants with type 2 diabetes and confirmed atherosclerotic heart disease will be randomized into two groups and treated with either tirzepatide or dulaglutide (more commonly known as Trulicity). Atherosclerotic heart disease is a buildup of plaque (formed from fats, cholesterol, and other substances) on the walls of your blood vessels. This plaque causes your blood vessels to be narrowed or even blocked, obstructing blood flow which can seriously damage your heart, blood vessels, and other organs. 

The main result being measured is the amount of time before one of three heart complications occurs – heart attack, death, or stroke. Other outcomes being measured include changes in weight, A1C, blood lipid levels, and uACR (a test that measures how your kidney is functioning by looking at the amount of a protein in your urine).

Why is the trial new and important?

Tirzepatide is a new glucose-lowering medicine called a “dual-agonist” or “dual GIP and GLP-1 receptor agonist.” Tirzeptide works by targeting two receptors on your cells that lead to insulin release and stops the release of glucagon. These two actions together helps lower blood glucose levels. In addition, tirzepatide slows down how fast food moves through your stomach, making you feel full for longer. The drug is a weekly injectable medication that can lead to substantial A1C reductions, weight loss, and less hypoglycemia in people with type 2 diabetes according to early clinical trial results. Tirzepatide is being evaluated for approval by the FDA. This clinical trial, along with a series of other SURPASS trials, will help evaluate the benefits of the new therapy for people with type 2 diabetes and could lead to its approval. 

You can read more about tirzepatide and its impressive results in other clinical trials in our article: “Tirzepatide Dramatically Lowers Weight and A1C.”

Heart disease is a serious problem for people with type 2 diabetes. In addition to reducing glucose levels, new therapies in type 2 diabetes need to help reduce the risk of heart complications. We now have extensive evidence that SGLT-2 inhibitors and GLP-1 receptor agonists help reduce the risk of heart disease in people with type 2 diabetes, but more research is needed on the heart-protective benefits of this experimental medicine, tirzepatide. This study is important in understanding if this new dual-agonist therapy can do more to treat heart disease and stroke in people with type 2 diabetes compared to already approved drugs like Trulicity.

Trial length: 54 months (4.5 years)

Trial location: The trial is global and is recruiting from 662 study locations across the US, Canada, Mexico, Australia, as well as several other countries in South America, Europe, and Asia.

Are you interested?

You may be eligible for this study if you:

  • Have been diagnosed with type 2 diabetes

  • Have confirmed atherosclerotic cardiovascular disease (a buildup of plaque from atherosclerosis in your blood vessels that can damage your heart and other organs)

  • Have an A1C between 7% and 10.5%

  • Have a BMI greater or equal to 25 kg/m2

  • Are at least 40 years old

  • Have not had a major cardiovascular event in the last 60 days

  • Do not have a history of severe hypoglycemia and/or hypoglycemia unawareness within the last 6 months

  • If you have had a prior health event such as heart attack, stroke, or angina, or confirmed evidence of damage to the arteries from fatty plaques, contact the number below to find out if you are eligible

You can see a full list of eligibility and exclusion criteria here.

For more information: Please call Eli Lilly’s clinical trials contact number at 1-877-285-4559 or 1-317-615-4559. You can also email [email protected].