A Study of Clazakizumab (LY5724886) in Adults With Elevated hsCRP and at Increased Risk for Cardiovascular Event
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Clazakizumab in Reducing hsCRP in Adults With Elevated hsCRP and Established ASCVD or at Increased Risk for ASCVD Events
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares clazakizumab with a placebo to see how it changes hsCRP, a blood marker of inflammation. It is for adults with high hsCRP who have a higher risk of a heart or blood vessel problem. Taking part lasts about 9 months.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have an hsCRP level from 2 to 15 mg/L at screening.
- Have at least one of these: heart or blood vessel disease caused by plaque buildup; obesity (BMI of 30 or higher); type 2 diabetes; high blood pressure; or stage 3 or 4 long-term kidney disease.
Who can't join
- A sudden heart or blood vessel event, or a hospital stay for worsening heart failure, within 60 days before screening; severe heart failure (Class III or IV); planned surgery to restore blood flow to the heart or other major surgery when assigned to a study group; or a mechanical heart valve needing long-term vitamin K-blocking blood thinners.
- Blood pressure with a top number of 160 or higher or a bottom number of 100 or higher at screening; type 1 diabetes; or type 2 diabetes with an A1c of 9% or higher. A1c measures average blood sugar.
- Nephrotic syndrome (kidneys leaking too much protein into urine), a kidney filtering rate below 15, a past kidney transplant, or dialysis or sudden kidney injury within 60 days before screening.
- Kidney disease present at birth or passed down in families; polycystic kidney disease (many kidney cysts); kidney inflammation from lupus; or ANCA-associated vasculitis (a type of blood vessel inflammation).
- Active tuberculosis (TB), untreated inactive TB, known hepatitis B or C, or certain serious, long-lasting, repeated, or unusual infections needing treatment within 12 weeks before screening. Also, significant active disease where the immune system attacks the body, or a known or suspected weak immune system, such as with HIV.
- Stomach or bowel ulcers within 12 months before screening; past diverticulitis (inflamed bowel pouches), a hole in the stomach or bowel, or major stomach or bowel surgery.
- Colchicine use within 14 days before screening or an expected need for it during the study; or steroids that affect the whole body within 14 days before screening.
- Recent use of medicines that weaken or change the immune system, including other medicines that block IL-6, within the study's set time limits; or long-term use of NSAIDs, a type of pain and inflammation medicine.
Simplified for readability. The official criteria below are what the study team uses.
Official 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)
Study sites (30)
AL
- Heart Center Research, LLC · Huntsville, AL 35801 · Study contact · 256-519-8472Walter Haught · Principal investigatorMore trials in Huntsville
AZ
- Pima Heart · Tucson, AZ 85741 · Study contact · 717-615-0659Ajay Tuli · Principal investigatorMore trials in Tucson
- Eclipse Clinical Research · Tucson, AZ 85745 · Study contact · 520-647-9926Eve Shapiro · Principal investigatorMore trials in Tucson
CA
- Thrive Clinical Research Group · Glendora, CA 91740 · Study contact · 626-727-7254Fahed Bitar · Principal investigatorMore trials in Glendora
FL
- Omega Research Orlando · Altamonte Springs, FL 32714 · Study contact · 386-668-4202Kwabena Ayesu · Principal investigatorMore trials in Altamonte Springs
- American Research Institute · Cutler Bay, FL 33157Manuel Garcia Estrada · Principal investigatorMore trials in Cutler Bay
- K2 Medical Research - Maitland · Maitland, FL 32751 · Study contact · 407-810-2790Neel Patel · Principal investigatorMore trials in Maitland
- Florida Institute For Clinical Research, LLC · Orlando, FL 32825 · Study contact · 407-658-0966Humberto Cruz · Principal investigatorMore trials in Orlando
GA
- North Georgia Clinical Research · Woodstock, GA 30189 · Study contact · 678-494-5735Bram Wieskopf · Principal investigatorMore trials in Woodstock
IL
- Accellacare - DuPage · Lombard, IL 60148Yoko Momoyama · Principal investigatorMore trials in Lombard
IN
- Franciscan Physician Network - Indiana Heart Physicians · Indianapolis, IN 46237Anthony Bashall · Principal investigatorMore trials in Indianapolis
MA
- K2 Medical Research - Foxborough · Foxborough, MA 02035Daniel Sacchetti · Principal investigatorMore trials in Foxborough
MI
- Revival Research Institute, LLC · Dearborn, MI 48126Qaiser Shafiq · Principal investigatorMore trials in Dearborn
MS
- Olive Branch Family Medical Center · Olive Branch, MS 38654-3514 · Study contact · 662-893-8474Randall Huling · Principal investigatorMore trials in Olive Branch
NV
- Excel Clinical Research, LLC · Las Vegas, NV 89109 · Study contact · 702-680-1500Robby Quintos · Principal investigatorMore trials in Las Vegas
- Palm Research Center Tenaya · Las Vegas, NV 89128 · Study contact · 702-736-5161Samer Nakhle · Principal investigatorMore trials in Las Vegas
NY
- Rochester Clinical Research - Buffalo · Buffalo, NY 14217 · Study contact · 716-415-8380Richard Carlson · Principal investigatorMore trials in Buffalo
- CHEAR Center LLC · The Bronx, NY 10455 · Study contact · 347-270-1111David Bernard · Principal investigatorMore trials in The Bronx
OH
- Velocity Clinical Research, Cincinnati, Springdale · Cincinnati, OH 45246 · Study contact · 513-671-8080Charles Eger · Principal investigatorMore trials in Cincinnati
PA
- Suburban Research Associates · West Chester, PA 19380Omer Abdullah · Principal investigatorMore trials in West Chester
- Cardiology Consultants of Philadelphia Yardley · Yardley, PA 19067 · Study contact · 215-321-7400Paul Grena · Principal investigatorMore trials in Yardley
SC
- Monroe Biomedical Research - Charleston · North Charleston, SC 29406 · Study contact · 803-766-2680Gregory Feldman · Principal investigatorMore trials in North Charleston
TX
- Horizon Clinical Research Group · Cypress, TX 77429 · Study contact · 949-491-0710Fadi Alameddine · Principal investigatorMore trials in Cypress
- Cardiovascular Specialists of Willowbrook · Houston, TX 77070 · Study contact · 949-491-0710Aditya Samal · Principal investigatorMore trials in Houston
- Texas Cardiology Associates of Houston · Kingwood, TX 77339Robert Salazar · Principal investigatorMore trials in Kingwood
- Revival Research Institute, LLC · McKinney, TX 75071Asad Karim · Principal investigatorMore trials in McKinney
- Texas Institute of Cardiology, PA · McKinney, TX 75071 · Study contact · 214-544-7555Faisal Wahid · Principal investigatorMore trials in McKinney
UT
- Ogden Clinic - Canyon View · Ogden, UT 84404 · Study contact · 385-271-0684Stephen Bruce · Principal investigatorMore trials in Ogden
VA
- Carient Heart & Vascular - Manassas · Manassas, VA 20109 · Study contact · 703-335-8750Hamid Taheri · Principal investigatorMore trials in Manassas
- Carient Heart and Vascular LLC-Reston · Reston, VA 20190Adeeb Aghdassi · Principal investigatorMore trials in Reston