Clinical trial
A Study of Clazakizumab (LY5724886) in Adults With Elevated hsCRP and at Increased Risk for Cardiovascular Event
Opening soon · Phase 2 · 4 countries · Registry ID NCT07783802
Opening soonPhase 2Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionAtherosclerosis, Cardiovascular Disease, Obesity, Hypertension, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
Full registry 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)
Treatments and study arms
Clazakizumab
Drug
Administered SC
Placebo
Drug
Administered SC
Primary outcomes
Percent Change from Baseline in hsCRPBaseline, Week 12
Study locations
47 locations were listed when this page was built. The first 40 are shown.
CARDIAMET Investigaciones Médicas🇦🇷 Buenos Aires, Argentina
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Cecilia ReynaPrincipal Investigator
CEMEDIC🇦🇷 Buenos Aires, Argentina
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Facundo LombardiPrincipal Investigator
CIPREC🇦🇷 Buenos Aires, Argentina
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Cesar ZaidmanPrincipal Investigator
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada🇦🇷 Buenos Aires, Argentina
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Emilio AlaguibePrincipal Investigator
Cicemo Srl🇦🇷 Buenos Aires, Argentina
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Pablo CostanzoPrincipal Investigator
Fundación Respirar🇦🇷 Buenos Aires, Argentina
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Marina UhrigPrincipal Investigator
Mautalen Salud e Investigación🇦🇷 Buenos Aires, Argentina
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Jose FretesPrincipal Investigator
Instituto Médico Catamarca IMEC🇦🇷 Rosario, Argentina
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Natacha MaldonadoPrincipal Investigator
Centro de Investigaciones Clinicas del Litoral🇦🇷 Santa Fe, Argentina
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Miguel HominalPrincipal Investigator
Centro de Salud e Investigaciones Médicas🇦🇷 Santa Rosa, Argentina
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Marcos MayerPrincipal Investigator
Minamino Cardiovascular Hospital🇯🇵 Hachiōji, Japan
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Yoshiki HataPrincipal Investigator
Takai Internal Medicine Clinic🇯🇵 Kamakura-shi, Japan
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Masahiko TakaiPrincipal Investigator
Nakakinen clinic🇯🇵 Naka, Japan
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Takeshi OsonoiPrincipal Investigator
International University of Health and Welfare Narita Hospital🇯🇵 Narita, Japan
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Tomoya HoshiPrincipal Investigator
Dorado Medical Complex🇵🇷 Dorado, Puerto Rico
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Luis Pagan-CardonaPrincipal Investigator
Wellness clinical Research Vega Baja🇵🇷 Vega Baja, Puerto Rico
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Gustavo Albizu AnguloPrincipal Investigator
Omega Research Orlando🇺🇸 Altamonte Springs, Florida, United States
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Kwabena AyesuPrincipal Investigator
Rochester Clinical Research - Buffalo🇺🇸 Buffalo, New York, United States
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Richard CarlsonPrincipal Investigator
Velocity Clinical Research, Cincinnati, Springdale🇺🇸 Cincinnati, Ohio, United States
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Charles EgerPrincipal Investigator
American Research Institute🇺🇸 Cutler Bay, Florida, United States
Manuel Garcia EstradaPrincipal Investigator
Horizon Clinical Research Group🇺🇸 Cypress, Texas, United States
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Fadi AlameddinePrincipal Investigator
Revival Research Institute, LLC🇺🇸 Dearborn, Michigan, United States
Qaiser ShafiqPrincipal Investigator
K2 Medical Research - Foxborough🇺🇸 Foxborough, Massachusetts, United States
Daniel SacchettiPrincipal Investigator
Thrive Clinical Research Group🇺🇸 Glendora, California, United States
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Fahed BitarPrincipal Investigator
Altru Health System🇺🇸 Grand Forks, North Dakota, United States
Puvanalingam AyyaduraiPrincipal Investigator
Cardiovascular Specialists of Willowbrook🇺🇸 Houston, Texas, United States
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Aditya SamalPrincipal Investigator
Heart Center Research, LLC🇺🇸 Huntsville, Alabama, United States
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Walter HaughtPrincipal Investigator
Franciscan Physician Network - Indiana Heart Physicians🇺🇸 Indianapolis, Indiana, United States
Anthony BashallPrincipal Investigator
Texas Cardiology Associates of Houston🇺🇸 Kingwood, Texas, United States
Robert SalazarPrincipal Investigator
Excel Clinical Research, LLC🇺🇸 Las Vegas, Nevada, United States
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Robby QuintosPrincipal Investigator
Palm Research Center Tenaya🇺🇸 Las Vegas, Nevada, United States
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Samer NakhlePrincipal Investigator
K2 Medical Research - Maitland🇺🇸 Maitland, Florida, United States
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Neel PatelPrincipal Investigator
Carient Heart & Vascular - Manassas🇺🇸 Manassas, Virginia, United States
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Hamid TaheriPrincipal Investigator
Revival Research Institute, LLC🇺🇸 McKinney, Texas, United States
Asad KarimPrincipal Investigator
Texas Institute of Cardiology, PA🇺🇸 McKinney, Texas, United States
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Faisal WahidPrincipal Investigator
Monroe Biomedical Research - Charleston🇺🇸 North Charleston, South Carolina, United States
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Gregory FeldmanPrincipal Investigator
Ogden Clinic - Canyon View🇺🇸 Ogden, Utah, United States
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Stephen BrucePrincipal Investigator
Olive Branch Family Medical Center🇺🇸 Olive Branch, Mississippi, United States
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Randall HulingPrincipal Investigator
Florida Institute For Clinical Research, LLC🇺🇸 Orlando, Florida, United States
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Humberto CruzPrincipal Investigator