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

Prior treatment

• 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
• Dialysis or acute kidney injury within 60 days prior to screening
• Serious, opportunistic, chronic, or recurrent infection requiring treatment within 12 weeks prior to screening
• History of peptic ulcer disease or gastrointestinal ulceration within 12 months prior to screening
• 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)

Other illness

• 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
• 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
• Significant active autoimmune disease
• Suspected or confirmed immunocompromised state (e.g., HIV infection)
• History of symptomatic diverticular disease (diverticulitis), gastrointestinal perforation, or major gastrointestinal surgery
• Mechanical heart valve prosthesis requiring chronic vitamin K antagonist anticoagulation

Lab values

• 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

• 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