AuthorisedTherapeutic use (Phase IV)Interventional

Changes in Coronary Plaque Composition By Semaglutide Use in Diabetic Patients With Acute Coronary Syndrome: A Randomized Optical Coherence Tomography Trial - ARMYDA - 10 study

This study, called ARMYDA-10, is for adults with diabetes who have recently experienced a heart issue like a mild heart attack or chest pain (unstable angina). Researchers want to see how a diabetes medication called Rybelsus (semaglutide) affects the fatty build-up, known as plaque, in their heart arteries. They will use a special tiny camera, called Optical Coherence Tomography (OCT), to look inside the arteries at the beginning of the study and again after 24 weeks. The main goal is to check for changes in certain cells (macrophages) within the plaque, as these can play a role in heart disease. The study will also look at overall plaque size, type, and how participants' diabetes and weight change, along with any other health events.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Enrolment target

Start

28 Jan 2026

non-ST-elevation myocardial infarction (NSTEMI)unstable angina diabetes mellitus

What is this study about?

This research, known as the ARMYDA-10 study, is focusing on adults who have two important health conditions: diabetes and recent heart problems. These heart problems could be a type of heart attack called NSTEMI, or unstable angina, which is chest pain that happens even when resting.

The main aim of the study is to understand if a specific diabetes medicine, called Rybelsus (which contains semaglutide), can help change the fatty deposits, or plaque, inside the heart's arteries. These plaques are made up of different things, including fat and cells that can cause inflammation. Controlling or changing these plaques could be really important for preventing future heart issues. To see these changes, doctors will use a very advanced imaging technique called Optical Coherence Tomography (OCT). This is like a tiny camera that can get a detailed look inside the arteries.

Over 24 weeks, researchers will compare people taking Rybelsus with those who are not, to see if the medicine has an effect on the plaque. They'll be particularly interested in how certain inflammatory cells (macrophages) within the plaque change. They will also look at features like plaque thickness and volume, how well diabetes is controlled (measured by HbA1c), weight changes, and overall heart health.

Key takeaways

Targets adults with diabetes and recent heart problems (NSTEMI or unstable angina).
Investigates if Rybelsus (semaglutide) can improve artery plaque.
Uses a special camera (OCT) to view plaque changes.
Looks at plaque features, diabetes control, and overall heart health.
Study lasts for 24 weeks with regular check-ups.

Who may be eligible?

This study is looking for adults who are at least 18 years old. Both men and women can take part.

To be considered for this study, you must have diabetes and have recently experienced a specific type of heart problem. This could be a mild heart attack (doctors call it NSTEMI) or chest pain that happens even when you’re resting (unstable angina).

There will be other health requirements that the study doctors will check to make sure the study is right and safe for you. These will be discussed in detail if you are interested.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have diabetes?
Have you recently experienced a heart attack (NSTEMI) or unstable chest pain?
Are you able to commit to 24 weeks of study participation and visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to either take the Rybelsus tablets or be in a control group (who would likely receive standard care or a placebo, which looks like the drug but contains nothing active). You would take the medication daily for 24 weeks. Participation would involve an initial visit where doctors would perform the special OCT imaging to look inside your heart arteries (baseline). Over the 24 weeks, you would have regular appointments to monitor your health, how you are feeling, and any changes in your medication. At the end of the 24 weeks, you would have another OCT scan and final check-ups. The total duration of active participation in the study, including follow-up, would be about 6 months.

Potential risks and benefits

Participating in this study might offer potential benefits, such as gaining a better understanding of your heart health and receiving close monitoring from medical professionals. If Rybelsus proves effective, it could help manage your heart disease. However, like all medications, Rybelsus may have side effects, which will be fully explained before you agree to participate. The OCT procedure itself has very small risks, your doctor will discuss these with you. You have the full right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is Rybelsus?

Rybelsus is a medication that helps manage blood sugar levels in people with type 2 diabetes. It's taken as a tablet.

What is 'plaque' in my arteries?

Plaque is a build-up of fatty materials, cholesterol, and other substances that can narrow and harden your arteries, which is a key part of heart disease.

What is OCT?

OCT (Optical Coherence Tomography) is a special imaging test that uses light to create very detailed pictures from inside your arteries, allowing doctors to see the plaque up close.

Why is this study important?

This study aims to find out if a diabetes medicine can also improve the health of arteries in people with both diabetes and heart problems, which could lead to better treatments in the future.

Will I know if I'm taking the real medicine or not?

No, this is a 'blinded' study, meaning neither you nor your study doctor will know if you're receiving Rybelsus or the control treatment until the study is over, to keep the results fair.