A Study of Clazakizumab (LY5724886) in Adults With Elevated hsCRP and at Increased Risk for Cardiovascular Event
Eli Lilly and Company · NCT07783802
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 120
- US sites recruiting
- 29
- Study start
- August 27, 2026
- Record last updated
- October 8, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the 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.
Being studied: Clazakizumab; Placebo
Conditions: Atherosclerosis; Cardiovascular Disease; Obesity; Hypertension; Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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)
Recruiting US locations
Heart Center Research, LLC
Huntsville, AL 35801
Site contact: 256-519-8472
Pima Heart
Tucson, AZ 85741
Site contact: 717-615-0659
Eclipse Clinical Research
Tucson, AZ 85745
Site contact: 520-647-9926
Thrive Clinical Research Group
Glendora, CA 91740
Site contact: 626-727-7254
Omega Research Orlando
Altamonte Springs, FL 32714
Site contact: 386-668-4202
American Research Institute
Cutler Bay, FL 33157
Site contact: Manuel Garcia Estrada
K2 Medical Research - Maitland
Maitland, FL 32751
Site contact: 407-810-2790
Florida Institute For Clinical Research, LLC
Orlando, FL 32825
Site contact: 407-658-0966
North Georgia Clinical Research
Woodstock, GA 30189
Site contact: 678-494-5735
Franciscan Physician Network - Indiana Heart Physicians
Indianapolis, IN 46237
Site contact: Anthony Bashall
K2 Medical Research - Foxborough
Foxborough, MA 02035
Site contact: Daniel Sacchetti
Revival Research Institute, LLC
Dearborn, MI 48126
Site contact: Qaiser Shafiq
Olive Branch Family Medical Center
Olive Branch, MS 38654-3514
Site contact: 662-893-8474
Excel Clinical Research, LLC
Las Vegas, NV 89109
Site contact: 702-680-1500
Palm Research Center Tenaya
Las Vegas, NV 89128
Site contact: 702-736-5161
Rochester Clinical Research - Buffalo
Buffalo, NY 14217
Site contact: 716-415-8380
CHEAR Center LLC
The Bronx, NY 10455
Site contact: 347-270-1111
Velocity Clinical Research, Cincinnati, Springdale
Cincinnati, OH 45246
Site contact: 513-671-8080
Suburban Research Associates
West Chester, PA 19380
Site contact: Omer Abdullah
Cardiology Consultants of Philadelphia Yardley
Yardley, PA 19067
Site contact: 215-321-7400
Monroe Biomedical Research - Charleston
North Charleston, SC 29406
Site contact: 803-766-2680
Horizon Clinical Research Group
Cypress, TX 77429
Site contact: 949-491-0710
Cardiovascular Specialists of Willowbrook
Houston, TX 77070
Site contact: 949-491-0710
Texas Cardiology Associates of Houston
Kingwood, TX 77339
Site contact: Robert Salazar
Revival Research Institute, LLC
McKinney, TX 75071
Site contact: Asad Karim
Texas Institute of Cardiology, PA
McKinney, TX 75071
Site contact: 214-544-7555
Ogden Clinic - Canyon View
Ogden, UT 84404
Site contact: 385-271-0684
Carient Heart & Vascular - Manassas
Manassas, VA 20109
Site contact: 703-335-8750
Carient Heart and Vascular LLC-Reston
Reston, VA 20190
Site contact: Adeeb Aghdassi
Study contacts (from the official record)
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 317-615-4559 · LillyTrials@Lilly.com
- Physicians interested in becoming principal investigators please contact · clinical_inquiry_hub@lilly.com
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