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Study of YMI024 to Reduce Inflammation in Adults with Stable Coronary Artery Disease and Elevated hsCRP

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on adults who have stable Coronary Artery disease and an increased level of a blood protein called hsCRP, which signals inflammation. Some participants may also have other conditions such as Chronic Kidney Disease or Heart Failure. The experimental medicine being tested is identified by the code name YMI024. A control group will receive an inactive substance known as placebo. The goal is to see whether YMI024 can lower inflammation without causing safety problems.

The purpose of the trial is to evaluate how different doses of YMI024 affect the reduction of inflammatory markers, especially the proteins IL-6 and hsCRP, compared with placebo. IL-6 is a protein that the body releases during inflammation, and hsCRP is a blood test that measures overall inflammation level. By measuring changes in these proteins, researchers can tell if the medicine is working.

Participants will be assigned by chance to receive either the study drug at one of several dose levels or the placebo, and neither the participants nor the study staff will know which one is given (double‑blind). Over several weeks, they will attend clinic visits where blood samples are taken to check IL-6, hsCRP, and other safety labs, and an ECG will be performed to monitor heart rhythm. Information on any side effects and vital signs will be recorded throughout the treatment period.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    After joining the study you will sign the consent form and confirm that you meet the eligibility criteria for stable coronary artery disease with elevated hscrp.

    The study staff will record basic information such as age, medical conditions and current medications.

  2. Step 2

    Baseline assessments

    A series of initial tests will be performed before any study medication is taken.

    These include blood tests to measure inflammatory markers such as il‑6 and hscrp, kidney function, and other routine laboratory values.

    Vital signs, an electrocardiogram (ecg), and a review of your medical history will also be collected.

  3. Step 3

    <b>randomization</b>

    Based on a computer‑generated schedule you will be assigned, without knowing which one, to receive either ymi024 or a matching placebo.

    The study is double‑blind, meaning neither you nor the study staff will know which product you receive during the trial.

  4. Step 4

    <b>study medication</b> administration

    You will be instructed on how to take the assigned medication, including the amount (dose), how often (frequency), and for how long (duration).

    The exact dose and schedule will be provided by the study team and must be followed exactly as written.

  5. Step 5

    <b>follow‑up visits</b>

    Regular clinic visits will be scheduled throughout the treatment period.

    At each visit you will have vital signs checked, an ecg performed if required, and blood samples taken to monitor il‑6, hscrp and other safety laboratory values.

    Any side effects or adverse events you experience will be recorded and evaluated.

  6. Step 6

    <b>final assessment</b>

    At the end of the treatment period a comprehensive evaluation will be performed.

    The same laboratory tests and safety assessments done at baseline will be repeated to determine changes in inflammatory markers.

    The study medication will be stopped after this final assessment.

  7. Step 7

    Study completion

    After the final assessment you will be thanked for your participation.

    Your data will be analyzed to determine the effect of ymi024 on inflammatory markers and safety in people with coronary artery disease.

Who can join the trial?

6 criteria

  • Signed informed consent must be obtained and the participant must be able to understand and follow the study requirements.
  • Participant must be a male or female aged 18 to 80 years at the time of screening.
  • Participant must have a confirmed diagnosis of coronary artery disease (CAD), a condition where the arteries that supply the heart become narrowed.
  • Participant must have a blood CRP (C‑reactive protein) level of at least 2 mg/L, which indicates increased inflammation.
  • Participant may be taking standard treatments for high blood pressure, high cholesterol, diabetes, kidney disease, or heart problems.
  • Participant may have ongoing kidney disease or heart failure (a condition where the heart does not pump blood as well as it should).

Who cannot join the trial?

3 criteria

  • Had open heart surgery (a major operation where the chest is opened to work on the heart) within the past 6 months.
  • Had a heart attack (also called a myocardial infarction, when blood flow to part of the heart stops) within 30 days before joining the study.
  • Has an autoimmune disease such as rheumatoid arthritis, Crohn’s disease, or ulcerative colitis and is taking special medicines for it, or has a long‑lasting infection like hepatitis B or hepatitis C.
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Investigated drugs

YMI024 is an experimental medicine being studied to see if it can lower inflammation in people who have stable coronary artery disease and higher levels of a blood marker called hsCRP. In the trial, participants receive YMI024 in several different amounts to find the dose that works best while staying safe. Researchers will check how the drug changes inflammation markers and will watch closely for any side effects. The overall aim is to determine whether YMI024 can help reduce heart‑related inflammation and improve health for patients with this condition.

What is already known about the treatment

YMI024 - YMI024 is an investigational oral medication being evaluated in a phase 2b study for people with stable coronary artery disease and high hsCRP levels. The drug is not yet approved and is currently only available within clinical trials. It is designed to lower inflammation by interfering with the molecular signals that activate immune cells, which reduces the level of inflammatory markers in the blood. Because of this action, YMI024 is classified as an anti‑inflammatory agent.

Investigated diseases

  • Chronic Kidney Disease

    a condition where kidney function gradually declines over time, reducing the ability to filter waste. It often starts with mild loss of function and can progress to more severe impairment. As the disease advances, fluid and electrolyte balance may become disturbed. The kidneys may become smaller and scarred. Symptoms may increase as filtration worsens.

  • Heart Failure

    a condition in which the heart cannot pump blood effectively to meet the body's needs. It may begin with the heart working harder to compensate for damage. Over time the heart muscle can become weakened or stiff, reducing output. Fluid can build up in the lungs or limbs as the circulation slows. The condition can worsen gradually if the underlying cause persists.

  • Coronary Artery Disease

    a condition where the arteries that supply the heart become narrowed by plaque buildup. This narrowing limits blood flow to heart muscle, especially during exertion. As plaque grows, the arteries may become blocked, causing chest discomfort. The disease can progress silently for years before symptoms appear. Ongoing plaque accumulation can further restrict blood flow.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-525974-21-00Protocol codeCYMI024A12202Estimated enrolment171 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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