Clazakizumab for adults with high hsCRP at risk for a heart event

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial compares clazakizumab to placebo in adults who have elevated hsCRP (2–15 mg/L) and at least one cardiometabolic condition such as ASCVD, obesity, type 2 diabetes, hypertension, or CKD with 3–4 stages. Participants will be followed for about 9 months to see changes in high-sensitivity C-reactive protein, a marker of inflammation, while receiving monthly injections or placebo. The study excludes recent acute cardiovascular events, severe heart failure, uncontrolled hypertension, and certain diabetes or kidney disease severities. The lead sponsor is Eli Lilly, with sites in Huntsville, AL and Tucson, AZ. Interventions are clazakizumab or placebo, with outcomes focused on inflammatory status and cardiovascular risk markers.

Why it matters

Who can join: the full rules

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)

Where it's running

• Heart Center Research, LLC
  Huntsville, Alabama, United States Recruiting
• Pima Heart
  Tucson, Arizona, United States Recruiting
• Eclipse Clinical Research
  Tucson, Arizona, United States Recruiting
• Thrive Clinical Research Group
  Glendora, California, United States Recruiting
• Omega Research Orlando
  Altamonte Springs, Florida, United States Recruiting
• American Research Institute
  Cutler Bay, Florida, United States Recruiting

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.