Dose-finding test of YMI024 in adults with stable coronary artery disease and high hsCRP
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
Run by Novartis · NCT07830719 · Data updated 2026-11-12
This study tests several doses of YMI024 to see if it reduces inflammation and is safe for adults with stable CAD and elevated hsCRP, compared to placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Novartis Industry-sponsored |
| Locations | 23 sites (Fairhope, Alabama and 22 other locations) |
| Status | Recruiting |
| Started | September 18, 2026 |
| Main results expected | August 15, 2027 |
| Study ends | August 15, 2027 |
| Registry record updated | October 15, 2026 |
| Trial ID | NCT07830719 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-80 with documented stable CAD and hsCRP ≥ 2 mg/L, on stable standard-of-care therapies, and with stratified comorbidity status (CAD-only, CAD+ HF, or CAD+ CKD).
✕Probably not a fit
Participants without persistent inflammation or who do not respond to YMI024 may not experience a benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 2b trial randomizes participants with stable coronary artery disease and residual inflammatory risk (hsCRP ≥ 2 mg/L) to six arms (five YMI024 doses and placebo) in a double-blind design. Participants are stratified by comorbidity status (CAD-only, CAD with heart failure, or CAD with CKD) and continue with standard-of-care therapies. The study evaluates dose response, safety, tolerability, and anti-inflammatory effects over time. All treatments and procedures are blinded and identical in appearance across arms. Enrollment includes adults aged 18-80 who have documented CAD and meet the inclusion criteria.
Why it matters
Potential benefit: If successful, YMI024 could reduce systemic inflammation in people with stable CAD, potentially lowering cardiovascular risk.
How similar studies have gone: Other anti-inflammatory approaches in CAD have shown signals of benefit, but this specific dose-finding approach with YMI024 is novel for this population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Signed informed consent 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 clinically relevant 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 Glomerular Filtration Rate (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:
* 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.
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:
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, Transient ischemic attack (TIA), or acute limb ischemia within 12 weeks prior to Screening or Pre-screening, where applicable).
3. 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.
4. 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.
5. 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.
6. Participants with any of the following renal or hepatic abnormalities at Screening are excluded:
1. Renal dysfunction with Estimated Glomerular Filtration Rate (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: 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).
7. Current or prior history of severe heart failure of New York Heart Association (NYHA) Class IV.
Other protocol-defined inclusion/exclusion criteria may apply
Where it's running
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Eastern Shore Research Institute
Fairhope, Alabama, United States Recruiting -
G and L Research LLC
Foley, Alabama, United States Recruiting -
Biopharma Informatic LLC
Los Angeles, California, United States Recruiting -
AMR Miami
Coral Gables, Florida, United States Recruiting -
Alliance for Multispecialty Research
Wichita, Kansas, United States Recruiting -
Anderson Medical Research
Ft. Washington, Maryland, United States Recruiting
Show 17 more locations
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MD Medical Research
Oxon Hill, Maryland, United States Recruiting -
Pharma Tex Research
Amarillo, Texas, United States Recruiting -
Selma Medical Associates
Winchester, Virginia, United States Recruiting -
Novartis Investigative Site
Adelaide, South Australia, Australia Recruiting -
Novartis Investigative Site
Frankston, Victoria, Australia Recruiting -
Novartis Investigative Site
Melbourne, Victoria, Australia Recruiting -
Novartis Investigative Site
Mulgrave, Victoria, Australia Recruiting -
Novartis Investigative Site
Stuttgart, Baden-Wurttemberg, Germany Recruiting -
Novartis Investigative Site
Kaiserslautern, Rhineland-Palatinate, Germany Recruiting -
Novartis Investigative Site
Berlin, Germany Recruiting -
Novartis Investigative Site
Mannheim, Germany Recruiting -
Novartis Investigative Site
Pirna, Germany Recruiting -
Novartis Investigative Site
Kasugai, Aichi-ken, Japan Recruiting -
Novartis Investigative Site
Matsudo, Chiba, Japan Recruiting -
Novartis Investigative Site
Kamakura, Kanagawa, Japan Recruiting -
Novartis Investigative Site
Matsubara, Osaka, Japan Recruiting -
Novartis Investigative Site
London, United Kingdom Recruiting
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: 1-888-669-6682
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.