ClinicalTrials.gg
RecruitingNCT07830719Updated Oct 15, 2026

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

A Phase 2 interventional study of YMI024 and Placebo in Coronary Artery Disease, sponsored by Novartis Pharmaceuticals. Recruiting at 23 sites in 5 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Oct 15, 2026First sites in 4 new countriesPrimary completion moved+2 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Coronary artery disease
  • elevated hsCRP
  • inflammatory marker reduction
03

In context

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

This study's planned enrollment of 180 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.

Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed must be obtained prior to any study specific procedures, and participant able to understand and comply with study requirements.
  2. Male and female participants aged between 18-80 years (inclusive) at Screening.
  3. Documented stable CAD as evidenced by presence of at least one of the following criteria:

    1. 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.

    2. 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).

      • 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.
    3. 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.
    4. Coronary artery calcium (CAC) score of ≥300 AU by computed tomography.

    To ensure adequate representation of patients with comorbidities and to enable prespecified subgroup analyses, the trial will include participants with key comorbidities as follows:

    i. Moderate CKD Participants with moderate (Stage 3a/3b) kidney disease (CKD) defined as: Estimated (eGFR) ≥30 and ≤60 mL/min/1.73 m² (CKD EPI formula) at Screening.

    ii. Chronic HF

    Participants with a history of chronic heart failure (HF) defined as:

    • 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
    • ≤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.
  4. 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.

Exclusion criteria

Exclusion Criteria:

  1. 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).
  2. Any major (cardiac or non-cardiac) surgical, interventional or endoscopic procedure (e.g: Percutaneous carotid intervention, carotid or peripheral arterial revascularization), or stroke, (TIA), or acute limb ischemia within 12 weeks prior to Screening or Pre-screening, where applicable).
  3. Participants with a known systemic 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.
  4. Patients with suspected or proven state at Screening (e.g., clinical diagnosis of (HIV) or on antiretroviral therapy, ≤1000/mm3) or any other medical condition in the opinion of the Investigator places the patient at unacceptable risk by receiving immunomodulatory therapy.
  5. Known or suspected active infection, or chronic or recurrent infectious disease, including but not limited to:

    • / : 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.
  6. Participants with any of the following renal or hepatic abnormalities at Screening are excluded:

    1. Renal dysfunction with Estimated (eGFR) \<30 mL/min/1.73 m² (using CKD-EPI formula; s://.kidney.org/professionals/gfr_calculator).
    2. Evidence of hepatic disease as determined by any one of the following: (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) or Alanine Aminotransferase (ALT) (Serum Glutamic Pyruvic Transaminase (SGPT)) >3× , or >1.5 mg/dL at Screening (for patients with Gilbert's syndrome, total bilirubin \<2× ULN is allowed).
  7. Current or prior history of severe heart failure of (NYHA) Class IV.

Other protocol-defined inclusion/exclusion criteria may apply

Terms in these criteria, in plain language(15)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    YMI024 Dose 1

    Participants receive YMI024 Dose 1 in addition to standard-of-care therapies.

    Drug: YMI024

  • Experimental
    YMI024 Dose 2

    Participants receive YMI024 Dose 2 in addition to standard-of-care therapies.

    Drug: YMI024

  • Experimental
    YMI024 Dose 3

    Participants receive YMI024 Dose 3 in addition to standard-of-care therapies.

    Drug: YMI024

  • Experimental
    YMI024 Dose 4

    Participants receive YMI024 Dose 4 in addition to standard-of-care therapies.

    Drug: YMI024

  • Experimental
    YMI024 Dose 5

    Participants receive YMI024 Dose 5 in addition to standard-of-care therapies.

    Drug: YMI024

  • Placebo comparator
    Placebo

    Participants receive a matching placebo in addition to standard-of-care therapies

    Drug: Placebo

Interventions

  • DrugYMI024

    YMI024 in different doses

  • DrugPlacebo

    matching placebo

06

What researchers measure

Primary outcomes

  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

    Time frame: Baseline and approximately 3 months

Secondary outcomes

  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

    Time frame: 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)

    Time frame: Baseline and approximately 3 months

  3. Responder status - hsCRP <2 mg/L

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

    Time frame: Approximately 3 months

  4. Responder status - hsCRP <1 mg/L

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

    Time frame: Approximately 3 months

  5. Number of participants with adverse events

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

    Time frame: Approximately 4 months

07

Study locations

23 of 23 sites recruiting
  • Eastern Shore Research Institute
    Fairhope, Alabama 36532, United States
    Recruiting
  • G and L Research LLC
    Foley, Alabama 36535, United States
    Recruiting
  • Biopharma Informatic LLC
    Los Angeles, California 90035, United States
    Recruiting
    • Sanjana Andem · Contactsandem@biopharma.net · +1 919 233 0059
    • Christian Assad-Kottner · Principal investigator
  • AMR Miami
    Coral Gables, Florida 33134, United States
    Recruiting
  • Alliance for Multispecialty Research
    Wichita, Kansas 67207, United States
    Recruiting
  • Anderson Medical Research
    Ft. Washington, Maryland 20744, United States
    Recruiting
  • MD Medical Research
    Oxon Hill, Maryland 20745, United States
    Recruiting
  • Pharma Tex Research
    Amarillo, Texas 79106, United States
    Recruiting
    • Salma Villarreal · Contactsestradaptx@gmail.com · +1 806 355 2581
    • David Brabham · Principal investigator
  • Selma Medical Associates
    Winchester, Virginia 22601, United States
    Recruiting
  • Novartis Investigative Site
    Adelaide, South Australia 5000, Australia
    Recruiting
  • Novartis Investigative Site
    Frankston, Victoria 3199, Australia
    Recruiting
  • Novartis Investigative Site
    Melbourne, Victoria 8008, Australia
    Recruiting
  • Novartis Investigative Site
    Mulgrave, Victoria 3170, Australia
    Recruiting
  • Novartis Investigative Site
    Stuttgart, Baden-Wurttemberg 70376, Germany
    Recruiting
  • Novartis Investigative Site
    Kaiserslautern, Rhineland-Palatinate 67655, Germany
    Recruiting
  • Novartis Investigative Site
    Berlin, 10787, Germany
    Recruiting
  • Novartis Investigative Site
    Mannheim, 68165, Germany
    Recruiting
  • Novartis Investigative Site
    Pirna, 01796, Germany
    Recruiting
  • Novartis Investigative Site
    Kasugai, Aichi-ken 4870016, Japan
    Recruiting
  • Novartis Investigative Site
    Matsudo, Chiba 2702251, Japan
    Recruiting
  • Novartis Investigative Site
    Kamakura, Kanagawa 2478533, Japan
    Recruiting
  • Novartis Investigative Site
    Matsubara, Osaka 5800032, Japan
    Recruiting
  • Novartis Investigative Site
    London, EC1A 7BE, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Sites
22 sites added — first sites in Germany, Japan, United Kingdom and United States
Show 22 added (9 United States, 5 Germany, 4 Japan, 3 Australia, 1 United Kingdom)
  • Eastern Shore Research Institute · Fairhope, United States
  • G and L Research LLC · Foley, United States
  • Biopharma Informatic LLC · Los Angeles, United States
  • AMR Miami · Coral Gables, United States
  • Alliance for Multispecialty Research · Wichita, United States
  • Anderson Medical Research · Ft. Washington, United States
  • MD Medical Research · Oxon Hill, United States
  • Pharma Tex Research · Amarillo, United States
  • Selma Medical Associates · Winchester, United States
  • Novartis Investigative Site · Frankston, Australia
  • Novartis Investigative Site · Melbourne, Australia
  • Novartis Investigative Site · Mulgrave, Australia
  • Novartis Investigative Site · Stuttgart, Germany
  • Novartis Investigative Site · Kaiserslautern, Germany
  • Novartis Investigative Site · Berlin, Germany
  • Novartis Investigative Site · Mannheim, Germany
  • Novartis Investigative Site · Pirna, Germany
  • Novartis Investigative Site · Kasugai, Japan
  • Novartis Investigative Site · Matsudo, Japan
  • Novartis Investigative Site · Kamakura, Japan
  • Novartis Investigative Site · Matsubara, Japan
  • Novartis Investigative Site · London, United Kingdom
Oct 15, 2026
Primary completion
Oct 19, 2027→Aug 15, 2027
Oct 15, 2026
Study completion
Oct 19, 2027→Aug 15, 2027
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    22 sites added — first sites in Germany, Japan, United Kingdom and United States
    Show 22 added (9 United States, 5 Germany, 4 Japan, 3 Australia, 1 United Kingdom)
    • Eastern Shore Research Institute · Fairhope, United States
    • G and L Research LLC · Foley, United States
    • Biopharma Informatic LLC · Los Angeles, United States
    • AMR Miami · Coral Gables, United States
    • Alliance for Multispecialty Research · Wichita, United States
    • Anderson Medical Research · Ft. Washington, United States
    • MD Medical Research · Oxon Hill, United States
    • Pharma Tex Research · Amarillo, United States
    • Selma Medical Associates · Winchester, United States
    • Novartis Investigative Site · Frankston, Australia
    • Novartis Investigative Site · Melbourne, Australia
    • Novartis Investigative Site · Mulgrave, Australia
    • Novartis Investigative Site · Stuttgart, Germany
    • Novartis Investigative Site · Kaiserslautern, Germany
    • Novartis Investigative Site · Berlin, Germany
    • Novartis Investigative Site · Mannheim, Germany
    • Novartis Investigative Site · Pirna, Germany
    • Novartis Investigative Site · Kasugai, Japan
    • Novartis Investigative Site · Matsudo, Japan
    • Novartis Investigative Site · Kamakura, Japan
    • Novartis Investigative Site · Matsubara, Japan
    • Novartis Investigative Site · London, United Kingdom
    Primary completion Oct 19, 2027→Aug 15, 2027
    Study completion Oct 19, 2027→Aug 15, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07830719
Responsible party
Sponsor
First posted
Sep 21, 2026
Start date
Sep 18, 2026
Primary completion
Aug 15, 2027 (estimated)
Completion
Aug 15, 2027 (estimated)
Last update
Oct 15, 2026

Study contacts

Novartis Pharmaceuticals
Contact
novartis.email@novartis.com
1-888-669-6682
Novartis Pharmaceuticals
Contact
+41613241111
Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion