RecruitingPhase 2

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

AZ

CA

FL

GA

IL

IN

  • Franciscan Physician Network - Indiana Heart Physicians · Indianapolis, IN 46237Anthony Bashall · Principal investigatorMore trials in Indianapolis

MA

MI

  • Revival Research Institute, LLC · Dearborn, MI 48126Qaiser Shafiq · Principal investigatorMore trials in Dearborn

MS

NV

NY

OH

PA

SC

TX

UT

VA