RecruitingPHASE2INTERVENTIONAL

Dose-finding Study of YMI024 to Assess Efficacy, Safety, and Tolerability in Adults With Stable Coronary Artery Disease and Elevated hsCRP

This study is looking into a new medication called YMI024. It's for adults who have stable coronary artery disease (heart artery disease) and also have signs of ongoing inflammation in their body. The main goal is to find out if YMI024 can help lower this inflammation, and if so, how well it works at different doses. Researchers also want to check if the medication is safe to use and if people can tolerate it without too many side effects. Participants will receive either YMI024 or a dummy pill (placebo) alongside their usual heart medicines, and neither they nor their doctors will know which treatment they are getting.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Novartis Pharmaceuticals

Enrolment target

180

Start

18 Sep 2026

Estimated completion

15 Aug 2027

Coronary Artery Disease

What is this study about?

This study is looking at a new medication, YMI024, for adults who have coronary artery disease (CAD). CAD is a condition where the main blood vessels supplying the heart become narrowed or blocked, usually by fatty deposits. This can lead to chest pain (angina) or heart attacks. Even when the condition is stable and being treated, some people still have signs of inflammation in their body. This ongoing inflammation, measured by a blood test called high-sensitivity C-reactive protein (hsCRP), might mean they are at higher risk of future heart problems.

The main idea behind this study is to see if YMI024 can help to reduce this inflammation. If it can, it might offer a new way to help people with stable CAD. The study is also trying to figure out the best dose of YMI024 to use, as well as checking its safety and if people can take it without serious side effects. Participants will continue to take their usual heart medications throughout the study.

This is a 'Phase 2' study, which means it's one of the earlier stages of testing a new medicine. It's designed to gather more information about how the drug works and its best dosage, after initial tests have shown it to be safe enough to be given to a larger group of people. The results from this study will help decide if YMI024 should move on to larger, later-stage studies.

Key takeaways

This study is testing a new drug, YMI024, for stable coronary artery disease.
It aims to see if YMI024 can reduce inflammation in people with elevated hsCRP levels.
The study also checks different doses for safety and how well they work.
Participants will receive either YMI024 or a dummy pill (placebo) alongside their usual medicines.
It's a 'Phase 2' study, an earlier stage of drug testing.

Who may be eligible?

This study is looking for adults between 18 and 80 years old. To join, you need to have stable coronary artery disease (CAD). This means your heart condition has been diagnosed and is under control.

Your CAD needs to be confirmed in one of the following ways: you've had a heart attack at least 30 days ago, or you've had a procedure to clear heart arteries (like a stent or bypass surgery) at least 30 days or 6 months ago, depending on the type of procedure. Another way is if scans show your heart arteries are narrowed, or if a specific score from a heart scan is high.

Alongside your stable CAD, you also need to have a blood test result showing elevated levels of inflammation (specifically, your hsCRP level must be 2 mg/L or higher). The study is also specifically including people with certain other health conditions, such as mild to moderate chronic kidney disease or a history of chronic heart failure, to ensure the findings are relevant to a wide range of patients.

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 between 18 and 80 years old?
Do you have stable coronary artery disease (CAD)?
Have you had a heart attack or heart procedure (stent/bypass) at least a month/six months ago?
Do you have signs of inflammation (elevated hsCRP blood test)?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be randomly put into one of six groups. Five of these groups will receive different doses of the study medication, YMI024, and one group will receive a 'placebo', which is a dummy pill that looks exactly like the real medication but contains no active drug. You and your study doctors will not know which treatment you are receiving; this is called 'double-blinding' and helps ensure the results are fair.

You will take the study medication alongside your usual treatments for heart disease. You would have several visits to the clinic for assessments, which will likely include blood tests, physical examinations, and possibly other tests to check your heart health and inflammation levels. The total duration of your participation in the study, including the number of visits and follow-up, would be fully explained by the study team. They will also tell you exactly what is expected at each visit.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that the new medication, YMI024, might help reduce inflammation in your body, which could improve your heart health. You would also receive close medical monitoring during the study. However, there's no guarantee the treatment will help you, and it might not work as expected. As with any medication, there's a possibility of side effects, which the study team will explain in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (23)

Eastern Shore Research Institute
Verified postcode
Fairhope, United States· Recruiting
G and L Research LLC
Verified postcode
Foley, United States· Recruiting
Biopharma Informatic LLC
Verified postcode
Los Angeles, United States· Recruiting
AMR Miami
Verified postcode
Coral Gables, United States· Recruiting
Alliance for Multispecialty Research
Verified postcode
Wichita, United States· Recruiting
Anderson Medical Research
Verified postcode
Ft. Washington, United States· Recruiting
MD Medical Research
Verified postcode
Oxon Hill, United States· Recruiting
Pharma Tex Research
Verified postcode
Amarillo, United States· Recruiting
Selma Medical Associates
Verified postcode
Winchester, United States· Recruiting
Novartis Investigative Site
Verified postcode
Adelaide, Australia· Recruiting
Novartis Investigative Site
Verified postcode
Frankston, Australia· Recruiting
Novartis Investigative Site
Verified postcode
Melbourne, Australia· Recruiting

Common questions

What is coronary artery disease (CAD)?

CAD is a common heart condition where the blood vessels supplying your heart become narrowed or blocked, usually due to fatty deposits. This can reduce blood flow to your heart muscle.

What does 'inflammation' mean in this study?

In this study, 'inflammation' refers to ongoing activity in your body's immune system, which can be measured by a blood test called hsCRP. High levels might indicate a higher risk of heart problems.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medication but doesn't contain any active drug. It helps researchers compare the effects of the new medicine fairly.

What does 'double-blind' mean?

Double-blind means that neither you nor your study doctors will know whether you are receiving the active medication (YMI024) or the placebo. This helps prevent bias in the study results.

Can I continue my other heart medications?

Yes, if you join this study, you will continue to take all your usual medications for your heart condition, as recommended by your doctor, alongside the study treatment.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com 1-888-669-6682 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.