A Study of Clazakizumab (LY5724886) in Adults With Elevated hsCRP and at Increased Risk for Cardiovascular Event

Inclusion Criteria:

* hsCRP ≥2 mg/L and ≤15 mg/L at screening
* At least one of the following chronic conditions:

  * Established atherosclerotic cardiovascular disease (ASCVD)
  * Obesity (body mass index (BMI) ≥30 kg/m2)
  * Type 2 diabetes
  * Hypertension
  * Chronic kidney disease Grade 3 or 4

Exclusion Criteria:

* Acute cardiovascular event within 60 days prior to screening
* Acute decompensated heart failure hospitalization within 60 days prior to screening
* Planned coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or major surgery at the time of randomization
* New York Heart Association Class III or IV heart failure
* Uncontrolled hypertension at screening (systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥100 mmHg)
* Type 1 diabetes
* Type 2 diabetes with Hemoglobin A1c ≥9.0% (86 mmol/mol) at screening
* Nephrotic syndrome, estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73 m², or history of kidney transplant
* Dialysis or acute kidney injury within 60 days prior to screening
* Congenital/hereditary kidney disease, polycystic kidney disease, lupus nephritis, or antineutrophil cytoplasmic antibody-associated vasculitis
* Active tuberculosis, untreated latent tuberculosis, or known hepatitis B or hepatitis C infection
* Serious, opportunistic, chronic, or recurrent infection requiring treatment within 12 weeks prior to screening
* Significant active autoimmune disease
* Suspected or confirmed immunocompromised state (e.g., HIV infection)
* History of peptic ulcer disease or gastrointestinal ulceration within 12 months prior to screening
* History of diverticular disease, gastrointestinal perforation, or major gastrointestinal surgery
* Mechanical heart valve prosthesis requiring chronic vitamin K antagonist anticoagulation
* Use of colchicine within 14 days prior to screening or anticipated need during the study
* Use of immunosuppressive or immunomodulatory agents, including other biologic anti-IL-6 therapies, within specified windows prior to screening
* Use of systemic corticosteroids within 14 days prior to screening
* Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs)