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Trial eligibility change
| eligibility_criteria | 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) | → | 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 symptomatic diverticular disease (diverticulitis), 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) |
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