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Coronary Artery DiseasePhase 2NCT07830719

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

A Phase 2 study testing YMI024 in people with Coronary Artery Disease, run by Novartis Pharmaceuticals at 23 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this Phase 2b study is to investigate the efficacy in reducing systemic inflammation, safety, tolerability, and dose response of five doses of YMI024, as compared to placebo in adult participants with stable coronary artery disease (CAD) and residual inflammatory risk defined by elevated… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
YMI024
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
23 sitesin 5 countries
Study dates
18 Sep 2026to 15 Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent must be obtained prior to any study specific procedures, and participant able to understand and comply with study requirements.
  • Male and female participants aged between 18-80 years (inclusive) at Screening.
  • Documented stable CAD as evidenced by presence of at least one of the following criteria:
  • Documented history of spontaneous (Type 1) myocardial infarction (MI) of presumed atherosclerotic origin that occurred at least 30 days before the start of Screening. If a Pre-screening visit is conducted, the MI must have occurred at least 30 days before that visit.
  • Diagnosis of the qualifying MI should be based on medical records and Investigator's judgment.
  • Prior coronary revascularization (i.e. percutaneous coronary intervention (PCI) at least 30 days prior, or coronary artery bypass grafting (CABG), at least 6 months prior to Screening).
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  • Any prior PCI must have occurred at least 30 days prior to the Screening Visit (or if conducted, prior to the Pre screening visit).
  • Any prior CABG must have occurred at least 6 months (i.e. 26 weeks) prior to the Screening (or if conducted, prior to the Pre-screening) Visit.
  • Angiographic or CT-imaging (e.g., Multi Detector Computed Tomography/ Computed Tomography Angiography (MDCT/CTA)) evidence of coronary atherosclerosis: ≥50% stenosis in at least one major epicardial coronary artery.
  • Coronary artery calcium (CAC) score of ≥300 AU by computed tomography.
  • To ensure adequate representation of patients with clinically relevant comorbidities and to enable prespecified subgroup analyses, the trial will include participants with key comorbidities as follows:
  • Moderate CKD Participants with moderate (Stage 3a/3b) kidney disease (CKD) defined as: Estimated Glomerular Filtration Rate (eGFR) ≥30 and ≤60 mL/min/1.73 m² (CKD EPI formula) at Screening.
  • Chronic HF
  • Participants with a history of chronic heart failure (HF) defined as:
  • NYHA Class II-III symptoms of HF requiring ongoing treatment with diuretics (loop diuretics, thiazide diuretics, and/or mineralocorticoid receptor antagonists) for ≥30 days prior to Screening, AND
  • LVEF ≤40%, assessed by any standard modality (e.g., echocardiography, cardiac Magnetic Resonance Imaging (MRI), CT, MUGA, or ventricular angiography) on the most recent assessment within 12 months prior to Screening.
  • Participants must have hsCRP levels ≥2 mg/L at two timepoints during Screening. Screening values must be separated by a minimum of 7 days. The initial hsCRP value must be a minimum of 30 days after a qualifying MI or after any PCI performed separately from the qualifying MI, or 6 months after CABG.
  • Note: Participants who choose to enter the optional Pre-screening period must have an hsCRP level, measured at a local laboratory, that is considered by the Investigator to be ≥2 mg/L. This Pre-screening hsCRP value (measured at the local laboratory) must be obtained at least 30 days after a qualifying MI or after any PCI performed separately from the qualifying MI, or 6 months after a CABG.
  • Irrespective of any Pre-screening hsCRP value, all participants must have two central laboratory hsCRP levels ≥2 mg/L at the two Screening visits to be eligible for randomization into the study.

Who cannot join

  • Participants with recent major cardiovascular events or procedures, including:
  • myocardial infarction, unstable angina, or percutaneous coronary intervention within 30 days prior to Screening (or Pre-screening, if conducted), or
  • coronary artery bypass grafting or other cardiac surgery within 6 months prior to Screening (or Pre-screening, if conducted).
  • Any major (cardiac or non-cardiac) surgical, interventional or endoscopic procedure (e.g: Percutaneous carotid intervention, carotid or peripheral arterial revascularization), or stroke, Transient ischemic attack (TIA), or acute limb ischemia within 12 weeks prior to Screening or Pre-screening, where applicable).
  • Participants with a known systemic autoimmune or inflammatory disease (e.g., Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA)); clinically active diverticulitis or inflammatory bowel disease within 12 months prior to Screening; or a history of gastrointestinal perforation.
  • Patients with suspected or proven immunocompromised state at Screening (e.g., clinical diagnosis of Human Immunodeficiency Virus (HIV) or on antiretroviral therapy, absolute neutrophil count ≤1000/mm3) or any other medical condition in the opinion of the Investigator places the patient at unacceptable risk by receiving immunomodulatory therapy.
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  • Known or suspected active infection, or chronic or recurrent infectious disease, including but not limited to:
  • Hepatitis B / Hepatitis C: Positive HBsAg, positive anti-HBc, positive anti-HBs, or positive anti-Hepatitis C Virus (HCV) at Screening.
  • Note: Participants positive for anti-HBs after HBV vaccination but negative for HBsAg and anti-HBc are eligible per local guidelines and Sponsor agreement.
  • Note: Participants positive for anti-HBc but negative for HBV Deoxyribonucleic Acid (DNA) receiving prophylactic HBV antiviral treatment (e.g., entecavir, lamivudine) are eligible per local guidelines and Sponsor agreement.
  • Note: Participants positive for anti-HCV but consistently negative for HCV RNA >6 months after HCV antiviral treatment are eligible per local guidelines and Sponsor agreement.
  • Tuberculosis (TB): Active or latent TB as indicated by a positive QuantiFERON® TB Gold Plus test or T-SPOT® TB test at Screening.
  • Any other known active or suspected active infection, or chronic infection, or history of ongoing, chronic, or major recurrent infectious disease.
  • Participants with any of the following renal or hepatic abnormalities at Screening are excluded:
  • Renal dysfunction with Estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73 m² (using CKD-EPI formula; s://.kidney.org/professionals/gfr_calculator).
  • Evidence of hepatic disease as determined by any one of the following: Aspartate Aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) or Alanine Aminotransferase (ALT) (Serum Glutamic Pyruvic Transaminase (SGPT)) >3× ULN, or bilirubin >1.5 mg/dL at Screening (for patients with Gilbert's syndrome, total bilirubin <2× ULN is allowed).
  • Current or prior history of severe heart failure of New York Heart Association (NYHA) Class IV.
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

23 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Novartis Pharmaceuticals contact

1-888-669-6682

novartis.email@novartis.com

Novartis Pharmaceuticals contact

+41613241111

23 sites in 5 countries

United States9 sites, 9 recruiting

  • Pharma Tex Research

    Amarillo, Texas, 79106

    Salma Villarreal, +1 806 355 2581, sestradaptx@gmail.com

    David Brabham

    Recruiting

  • AMR Miami

    Coral Gables, Florida, 33134

    Ronitza Odreman, Ronitza.Odreman@amr-clinical.com

    Abid Chaudhry

    Recruiting

  • Eastern Shore Research Institute

    Fairhope, Alabama, 36532

    Creagh Williams, +1 251 928 8804, cwilliams@esriresearch.com

    Michael S Pursley

    Recruiting

  • G and L Research LLC

    Foley, Alabama, 36535

    Christine S Fuller, glresearch5@gmail.com

    Nidal Morrar

    Recruiting

  • Anderson Medical Research

    Ft. Washington, Maryland, 20744

    Ann-Marie Cobb, andersonmedicalresearch@gmail.com

    Felton Anderson

    Recruiting

  • Biopharma Informatic LLC

    Los Angeles, California, 90035

    Sanjana Andem, +1 919 233 0059, sandem@biopharma.net

    Christian Assad-Kottner

    Recruiting

  • MD Medical Research

    Oxon Hill, Maryland, 20745

    Marie Edwards, +1 301 839 2008, marie.edwards@mdmedicalresearch.com

    Stephen T Ong

    Recruiting

  • Alliance for Multispecialty Research

    Wichita, Kansas, 67207

    Loria Awadallah, +1 630 376 7858, loria.awadallah@amr-clinical.com

    Saifullah Nasir

    Recruiting

  • Selma Medical Associates

    Winchester, Virginia, 22601

    Heather Neff, +1 540 678 2800, hnresearch@selmamed.com

    Philip O Donnell

    Recruiting

Other trials in United States

Germany5 sites, 5 recruiting

  • Novartis Investigative Site

    Berlin, 10787

    Recruiting

  • Novartis Investigative Site

    Kaiserslautern, Rhineland-Palatinate, 67655

    Recruiting

  • Novartis Investigative Site

    Mannheim, 68165

    Recruiting

  • Novartis Investigative Site

    Pirna, 01796

    Recruiting

  • Novartis Investigative Site

    Stuttgart, Baden-Wurttemberg, 70376

    Recruiting

Other trials in Germany

Australia4 sites, 4 recruiting

  • Novartis Investigative Site

    Adelaide, South Australia, 5000

    Recruiting

  • Novartis Investigative Site

    Frankston, Victoria, 3199

    Recruiting

  • Novartis Investigative Site

    Melbourne, Victoria, 8008

    Recruiting

  • Novartis Investigative Site

    Mulgrave, Victoria, 3170

    Recruiting

Other trials in Australia

Japan4 sites, 4 recruiting

  • Novartis Investigative Site

    Kamakura, Kanagawa, 2478533

    Recruiting

  • Novartis Investigative Site

    Kasugai, Aichi-ken, 4870016

    Recruiting

  • Novartis Investigative Site

    Matsubara, Osaka, 5800032

    Recruiting

  • Novartis Investigative Site

    Matsudo, Chiba, 2702251

    Recruiting

Other trials in Japan

United Kingdom1 site, 1 recruiting

  • Novartis Investigative Site

    London, EC1A 7BE

    Recruiting

Other trials in United Kingdom

About this study

Official title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study of YMI024 to Assess Efficacy in Reducing Inflammatory Markers, Safety, and Tolerability in Adults With Stable Coronary Artery Disease and Elevated hsCRP

The purpose of this Phase 2b study is to investigate the efficacy in reducing systemic inflammation, safety, tolerability, and dose response of five doses of YMI024, as compared to placebo in adult participants with stable coronary artery disease (CAD) and residual inflammatory risk defined by elevated high-sensitivity C-reactive protein (hsCRP) (≥2 mg/L)

Read the detailed description

Participants are randomized in a 1:1:1:1:1:1 ratio to one of the six arms, with stratification by comorbidity status at randomization: CAD-only, CAD+ (Heart Failure) HF, and CAD+Chronic Kidney Disease (CKD), and receive study medication on top of stable standard-of-care therapies. The study employs double-blinding, concealing treatment allocation from participants, Investigators, Sponsor, and study staff, with identical packaging and labelling, schedule of administration and appearance for all study drugs.

Being tested
YMI024, Placebo
Keywords
Coronary artery disease, elevated hsCRP, inflammatory marker reduction
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YMI024Drug

    YMI024 in different doses

  • PlaceboDrug

    matching placebo

Study groups in NCT07830719
Study groupRoleWhat they receive
YMI024 Dose 1ExperimentalParticipants receive YMI024 Dose 1 in addition to standard-of-care therapies.
Receives: Drug: YMI024
YMI024 Dose 2ExperimentalParticipants receive YMI024 Dose 2 in addition to standard-of-care therapies.
Receives: Drug: YMI024
YMI024 Dose 3ExperimentalParticipants receive YMI024 Dose 3 in addition to standard-of-care therapies.
Receives: Drug: YMI024
YMI024 Dose 4ExperimentalParticipants receive YMI024 Dose 4 in addition to standard-of-care therapies.
Receives: Drug: YMI024
YMI024 Dose 5ExperimentalParticipants receive YMI024 Dose 5 in addition to standard-of-care therapies.
Receives: Drug: YMI024
PlaceboPlacebo comparatorParticipants receive a matching placebo in addition to standard-of-care therapies
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in log-transformed IL-6

    Change from baseline in log-transformed Interleukin-6 (IL-6) to evaluate the dose-response relationship using the Multiple Comparison Procedures (MCP) component of the Multiple Comparison Procedure-Modelling (MCP-Mod) methodology

    Measured: Baseline and approximately 3 months

Secondary outcomes (5)

  1. Change from baseline in log-transformed IL-6

    Change from baseline in log-transformed IL-6 to characterize the dose-response relationship for YMI024 in IL-6 using the model-based (Mod) component of the MCP-Mod methodology

    Measured: Baseline and approximately 3 months

  2. Change from baseline in log-transformed hsCRP

    Change from baseline in log-transformed high-sensitivity C-reactive protein (hsCRP)

    Measured: Baseline and approximately 3 months

  3. Responder status - hsCRP <2 mg/L

    Responder status (Yes/No), defined as hsCRP <2 mg/L

    Measured: Approximately 3 months

  4. Responder status - hsCRP <1 mg/L

    Responder status (Yes/No), defined as hsCRP <1 mg/L

    Measured: Approximately 3 months

  5. Number of participants with adverse events

    Number of participants with adverse events, including abnormal vital signs, ECGs, and laboratory assessments

    Measured: Approximately 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2026
  2. Study start18 Sep 2026
  3. Primary completion15 Aug 2027 (estimated)
  4. Study completion15 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07830719
Sponsor's protocol ID
CYMI024A12202
Other IDs
U1111-1339-3893
Status last verified
Oct 2026
First submitted
15 Sep 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing YMI024 in people with Coronary Artery Disease, run by Novartis Pharmaceuticals at 23 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Germany, Australia, Japan, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in log-transformed IL-6 (time frame: Baseline and approximately 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07830719.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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