Clinical trial for Atherosclerosis
Official title A Study of Clazakizumab (LY5724886) in Adults With Elevated hsCRP and at Increased Risk for Cardiovascular Event
ClinicalTrials.gov ID: NCT07783802
What this study is testing
What is Clazakizumab?
Clazakizumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for atherosclerosis.
Also referred to as LY5724886.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Huntsville, Alabama, United States
- Tucson, Arizona, United States
- Glendora, California, United States
- Altamonte Springs, Florida, United States
- Cutler Bay, Florida, United States
- Maitland, Florida, United States
- Orlando, Florida, United States
- Woodstock, Georgia, United States
- Lombard, Illinois, United States
- Indianapolis, Indiana, United States
- Foxborough, Massachusetts, United States
- Dearborn, Michigan, United States
- Olive Branch, Mississippi, United States
- Las Vegas, Nevada, United States
- Buffalo, New York, United States
- The Bronx, New York, United States
- Cincinnati, Ohio, United States
- West Chester, Pennsylvania, United States
- Yardley, Pennsylvania, United States
- North Charleston, South Carolina, United States
+ 17 more site(s).
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here - ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntsville, Alabama, United States; Tucson, Arizona, United States; Glendora, California, United States; Altamonte Springs, Florida, United States; Cutler Bay, Florida, United States; Maitland, Florida, United States and 31 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.