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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Eli Lilly and Company • ClinicalTrials.gov ID: NCT07783802

Registry updated: 2026-10-08
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Description

The purpose of this study is to measure the change in high-sensitivity C-reactive protein (hsCRP), a marker of inflammation in the body, with clazakizumab compared with placebo in adults who have elevated hsCRP and at increased risk for cardiovascular event. Participation in the study will last about 9 months.

Interventions

  • Clazakizumab (Drug)
    Administered SC
  • Placebo (Drug)
    Administered SC

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 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)

Conditions

Atherosclerosis Cardiovascular Disease Obesity Hypertension Diabetes Mellitus, Type 2 Renal Insufficiency, Chronic

Locations

  • Heart Center Research, LLC — Huntsville, Alabama, United States
  • Pima Heart — Tucson, Arizona, United States
  • Eclipse Clinical Research — Tucson, Arizona, United States
  • Thrive Clinical Research Group — Glendora, California, United States
  • Omega Research Orlando — Altamonte Springs, Florida, United States
  • American Research Institute — Cutler Bay, Florida, United States
  • K2 Medical Research - Maitland — Maitland, Florida, United States
  • Florida Institute For Clinical Research, LLC — Orlando, Florida, United States
  • North Georgia Clinical Research — Woodstock, Georgia, United States
  • Accellacare - DuPage — Lombard, Illinois, United States
  • Franciscan Physician Network - Indiana Heart Physicians — Indianapolis, Indiana, United States
  • K2 Medical Research - Foxborough — Foxborough, Massachusetts, United States
  • Revival Research Institute, LLC — Dearborn, Michigan, United States
  • Olive Branch Family Medical Center — Olive Branch, Mississippi, United States
  • Excel Clinical Research, LLC — Las Vegas, Nevada, United States
  • Palm Research Center Tenaya — Las Vegas, Nevada, United States
  • Rochester Clinical Research - Buffalo — Buffalo, New York, United States
  • CHEAR Center LLC — The Bronx, New York, United States
  • Velocity Clinical Research, Cincinnati, Springdale — Cincinnati, Ohio, United States
  • Suburban Research Associates — West Chester, Pennsylvania, United States
  • Cardiology Consultants of Philadelphia Yardley — Yardley, Pennsylvania, United States
  • Monroe Biomedical Research - Charleston — North Charleston, South Carolina, United States
  • Horizon Clinical Research Group — Cypress, Texas, United States
  • Cardiovascular Specialists of Willowbrook — Houston, Texas, United States
  • Texas Cardiology Associates of Houston — Kingwood, Texas, United States
  • Revival Research Institute, LLC — McKinney, Texas, United States
  • Texas Institute of Cardiology, PA — McKinney, Texas, United States
  • Ogden Clinic - Canyon View — Ogden, Utah, United States
  • Carient Heart & Vascular - Manassas — Manassas, Virginia, United States
  • Carient Heart and Vascular LLC-Reston — Reston, Virginia, United States
  • CIPREC — Buenos Aires, Argentina
  • Cicemo Srl — Buenos Aires, Argentina
  • CARDIAMET Investigaciones Médicas — Buenos Aires, Argentina
  • Mautalen Salud e Investigación — Buenos Aires, Argentina
  • CEMEDIC — Buenos Aires, Argentina
  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada — Buenos Aires, Argentina
  • Fundación Respirar — Buenos Aires, Argentina
  • Instituto Médico Catamarca IMEC — Rosario, Argentina
  • Centro de Investigaciones Clinicas del Litoral — Santa Fe, Argentina
  • Centro de Salud e Investigaciones Médicas — Santa Rosa, Argentina
  • Minamino Cardiovascular Hospital — Hachiōji, Japan
  • Takai Internal Medicine Clinic — Kamakura-shi, Japan
  • Nakakinen clinic — Naka, Japan
  • International University of Health and Welfare Narita Hospital — Narita, Japan
  • Dorado Medical Complex — Dorado, Puerto Rico
  • Wellness clinical Research Vega Baja — Vega Baja, Puerto Rico
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record