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Phase 2Recruiting

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

Sponsored by Eli Lilly and Company

About this study

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.

Where this study is enrolling (21)

  • Heart Center Research, LLC

    Huntsville, Alabama

    Call 256-519-8472

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  • Eclipse Clinical Research

    Tucson, Arizona

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  • Pima Heart

    Tucson, Arizona

    Call 520-838-3540

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  • Thrive Clinical Research Group

    Glendora, California

    Call 626-727-7254

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  • Omega Research Orlando

    Altamonte Springs, Florida

    Call 386-668-4202

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Show all 21 locations
  • Florida Institute For Clinical Research, LLC

    Orlando, Florida

    Call 407-658-0966

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  • K2 Medical Research - Maitland

    Maitland, Florida

    Call 407-810-2790

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  • North Georgia Clinical Research

    Woodstock, Georgia

    Call 678-494-5735

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  • Olive Branch Family Medical Center

    Olive Branch, Mississippi

    Call 662-893-8474

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  • Excel Clinical Research, LLC

    Las Vegas, Nevada

    Call 702-680-1500

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  • Palm Research Center Tenaya

    Las Vegas, Nevada

    Call 702-736-5161

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  • Rochester Clinical Research - Buffalo

    Buffalo, New York

    Call 716-415-8380

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  • CHEAR Center LLC

    The Bronx, New York

    Call 347-270-1111

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  • Velocity Clinical Research, Cincinnati, Springdale

    Cincinnati, Ohio

    Call 513-671-8080

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  • Cardiology Consultants of Philadelphia Yardley

    Yardley, Pennsylvania

    Call 215-321-7400

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  • Monroe Biomedical Research - Charleston

    North Charleston, South Carolina

    Call 803-766-2680

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  • Horizon Clinical Research Group

    Cypress, Texas

    Call 949-491-0710

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  • Texas Institute of Cardiology, PA

    McKinney, Texas

    Call 214-544-7555

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  • Cardiovascular Specialists of Willowbrook

    Houston, Texas

    Call (713) 791-1978

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  • Ogden Clinic - Canyon View

    Ogden, Utah

    Call 385-271-0684

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  • Carient Heart & Vascular - Manassas

    Manassas, Virginia

    Call 703-335-8750

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Who can participate

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)

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.