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Can calming inflammation shield the heart?

NCT ID NCT07783802

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This trial tests whether clazakizumab, an experimental anti-inflammatory drug, can lower a blood marker of inflammation called hsCRP in adults who have elevated levels and are at increased risk for heart problems. Participants must have conditions like established heart disease, obesity, type 2 diabetes, high blood pressure, or chronic kidney disease. The study compares the drug against a placebo over about 9 months to see if it safely reduces inflammation, which may help prevent future cardiovascular events.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
clazakizumab (an experimental anti-inflammatory drug given by injection)
What this could lead to
If it works, this could point toward a new way to lower inflammation and reduce the risk of heart attacks and strokes in people with chronic conditions like obesity, diabetes, or high blood pressure.
What could go wrong
This is an early-stage trial with only 120 participants, so results may not hold up in larger studies. The drug could also have side effects, and lowering inflammation may not directly translate into fewer heart events.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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)

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Conditions

The condition(s) this trial relates to.

atherosclerosis atherosclerotic cardiovascular disease cardiovascular disorder chronic kidney disease chronic renal failure syndrome hypertensive disorder Obesity obesity disorder type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atherosclerosis Cardiovascular disease Diabetes mellitus, type 2 Hypertension Obesity Renal insufficiency chronic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    47 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Accellacare - DuPage

    Lombard, Illinois, 60148, United States

  • Altru Health System

    Grand Forks, North Dakota, 58201, United States

  • American Research Institute

    Cutler Bay, Florida, 33157, United States

  • CARDIAMET Investigaciones Médicas

    Buenos Aires, C1014ACP, Argentina

  • CEMEDIC

    Buenos Aires, C1407GTN, Argentina

  • CHEAR Center LLC

    The Bronx, New York, 10455, United States

  • CIPREC

    Buenos Aires, 1061, Argentina

  • Cardiology Consultants of Philadelphia Yardley

    Yardley, Pennsylvania, 19067, United States

  • Cardiovascular Specialists of Willowbrook

    Houston, Texas, 77070, United States

  • Carient Heart & Vascular - Manassas

    Manassas, Virginia, 20109, United States

  • Carient Heart and Vascular LLC-Reston

    Reston, Virginia, 20190, United States

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Buenos Aires, C1425AGC, Argentina

  • Centro de Investigaciones Clinicas del Litoral

    Santa Fe, S3000FWO, Argentina

  • Centro de Salud e Investigaciones Médicas

    Santa Rosa, L6300, Argentina

  • Cicemo Srl

    Buenos Aires, 1424, Argentina

  • Dorado Medical Complex

    Dorado, 00646, Puerto Rico

  • Eclipse Clinical Research

    Tucson, Arizona, 85745, United States

  • Excel Clinical Research, LLC

    Las Vegas, Nevada, 89109, United States

  • Florida Institute For Clinical Research, LLC

    Orlando, Florida, 32825, United States

  • Franciscan Physician Network - Indiana Heart Physicians

    Indianapolis, Indiana, 46237, United States

  • Fundación Respirar

    Buenos Aires, C1426ABP, Argentina

  • Heart Center Research, LLC

    Huntsville, Alabama, 35801, United States

  • Horizon Clinical Research Group

    Cypress, Texas, 77429, United States

  • Instituto Médico Catamarca IMEC

    Rosario, 2000, Argentina

  • International University of Health and Welfare Narita Hospital

    Narita, 286-8520, Japan

  • K2 Medical Research - Foxborough

    Foxborough, Massachusetts, 02035, United States

  • K2 Medical Research - Maitland

    Maitland, Florida, 32751, United States

  • Mautalen Salud e Investigación

    Buenos Aires, C1128AAF, Argentina

  • Minamino Cardiovascular Hospital

    Hachiōji, 192-0918, Japan

  • Monroe Biomedical Research - Charleston

    North Charleston, South Carolina, 29406, United States

  • Nakakinen clinic

    Naka, 311-0113, Japan

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189, United States

  • Ogden Clinic - Canyon View

    Ogden, Utah, 84404, United States

  • Olive Branch Family Medical Center

    Olive Branch, Mississippi, 38654-3514, United States

  • Omega Research Orlando

    Altamonte Springs, Florida, 32714, United States

  • Palm Research Center Tenaya

    Las Vegas, Nevada, 89128, United States

  • Pima Heart

    Tucson, Arizona, 85741, United States

  • Revival Research Institute, LLC

    Dearborn, Michigan, 48126, United States

  • Revival Research Institute, LLC

    McKinney, Texas, 75071, United States

  • Rochester Clinical Research - Buffalo

    Buffalo, New York, 14217, United States

  • Suburban Research Associates

    West Chester, Pennsylvania, 19380, United States

  • Takai Internal Medicine Clinic

    Kamakura-shi, 247-0056, Japan

  • Texas Cardiology Associates of Houston

    Kingwood, Texas, 77339, United States

  • Texas Institute of Cardiology, PA

    McKinney, Texas, 75071, United States

  • Thrive Clinical Research Group

    Glendora, California, 91740, United States

  • Velocity Clinical Research, Cincinnati, Springdale

    Cincinnati, Ohio, 45246, United States

  • Wellness clinical Research Vega Baja

    Vega Baja, 00693, Puerto Rico

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