Last updated 6 days ago
A Study of Clazakizumab (LY5724886) in Adults With Elevated hsCRP and at Increased Risk for Cardiovascular Event
120 patients around the world
Available in Argentina, Puerto Rico, United States
Eli Lilly and Company
11Research sites
120Patients around the world
This study is for people with
Cardiovascular disease
Obesity
Arterial hypertension
Diabetes
Diabetes mellitus type 2
Renal disease
Renal Insufficiency
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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).
Sites
CIPREC Centro de Investigación y Prevención Cardiovascular - CABA
Centro Médico Maffei - CABA, Buenos Aires
Mautalen - Salud e Investigación - CABA
Centro Especialidades Médicas SRL (CEMEDIC)
Fundación Centro de Salud e Investigaciones Médicas (CESIM)
Cicemo - CABA
Instituto Medico Catamarca "IMEC"
Centro de Investigaciones Clínicas del Litoral SRL
Fundación Respirar
Wellness Clinical Research - Vega Baja
StudyCLARITY-CRP
SponsorEli Lilly and Company
Study typeInterventional
Conditions
Cardiovascular diseaseObesityArterial hypertensionDiabetes mellitus type 2Renal Insufficiency
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07783802
