Recruiting
Phase 2

Clazakizumab

Sponsor:

Eli Lilly and Company

Code:

NCT07783802

Conditions

Atherosclerosis

Cardiovascular Disease

Obesity

Hypertension

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Clazakizumab

Placebo

Study Details

Brief summary:

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.

Conditions

Atherosclerosis

Cardiovascular Disease

Obesity

Hypertension

Diabetes Mellitus, Type 2

Study ID

NCT07783802

Start date

Aug 27, 2026

Status verified date

Sep, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Clazakizumab Dose 1

Participants will receive clazakizumab subcutaneously (SC)

experimental: Clazakizumab Dose 2

Participants will receive clazakizumab SC

experimental: Clazakizumab Dose 3

Participants will receive clazakizumab SC

placebo comparator: Placebo

Participants will receive placebo SC

Interventions

Clazakizumab

Administered SC

Placebo

Administered SC

Primary outcome measure

  • Percent Change from Baseline in hsCRP [ Time Frame: Baseline, Week 12 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Heart Center Research, LLC

Recruiting

Huntsville, Alabama, United States, 35801

Contacts

256-519-8472

Principal Investigator:

Walter Haught

Eclipse Clinical Research

Recruiting

Tucson, Arizona, United States, 85745

Contacts

520-647-9926

Principal Investigator:

Eve Shapiro

Thrive Clinical Research Group

Recruiting

Glendora, California, United States, 91740

Contacts

626-727-7254

Principal Investigator:

Fahed Bitar

Omega Research Orlando

Recruiting

Altamonte Springs, Florida, United States, 32714

Contacts

386-668-4202

Principal Investigator:

Kwabena Ayesu

American Research Institute

Recruiting

Cutler Bay, Florida, United States, 33157

Principal Investigator:

Manuel Garcia Estrada

Florida Institute For Clinical Research, LLC

Recruiting

Orlando, Florida, United States, 32825

Contacts

407-658-0966

Principal Investigator:

Humberto Cruz

North Georgia Clinical Research

Recruiting

Woodstock, Georgia, United States, 30189

Contacts

678-494-5735

Principal Investigator:

Bram Wieskopf

K2 Medical Research - Foxborough

Recruiting

Foxborough, Massachusetts, United States, 02035

Principal Investigator:

Daniel Sacchetti

Revival Research Institute, LLC

Recruiting

Dearborn, Michigan, United States, 48126

Principal Investigator:

Qaiser Shafiq

Olive Branch Family Medical Center

Recruiting

Olive Branch, Mississippi, United States, 38654-3514

Contacts

662-893-8474

Principal Investigator:

Randall Huling

Excel Clinical Research, LLC

Recruiting

Las Vegas, Nevada, United States, 89109

Contacts

702-680-1500

Principal Investigator:

Robby Quintos

Palm Research Center Tenaya

Recruiting

Las Vegas, Nevada, United States, 89128

Contacts

702-736-5161

Principal Investigator:

Samer Nakhle

Velocity Clinical Research, Cincinnati, Springdale

Recruiting

Cincinnati, Ohio, United States, 45246

Contacts

513-671-8080

Principal Investigator:

Charles Eger

Suburban Research Associates

Recruiting

West Chester, Pennsylvania, United States, 19380

Principal Investigator:

Omer Abdullah

Cardiology Consultants of Philadelphia Yardley

Recruiting

Yardley, Pennsylvania, United States, 19067

Contacts

215-321-7400

Principal Investigator:

Paul Grena

Monroe Biomedical Research - Charleston

Recruiting

North Charleston, South Carolina, United States, 29406

Contacts

803-766-2680

Principal Investigator:

Gregory Feldman

Horizon Clinical Research Group

Recruiting

Cypress, Texas, United States, 77429

Contacts

949-491-0710

Principal Investigator:

Fadi Alameddine

Cardiovascular Specialists of Willowbrook

Recruiting

Houston, Texas, United States, 77070

Contacts

949-491-0710

Principal Investigator:

Aditya Samal

Revival Research Institute, LLC

Recruiting

McKinney, Texas, United States, 75071

Principal Investigator:

Asad Karim

Texas Institute of Cardiology, PA

Recruiting

McKinney, Texas, United States, 75071

Contacts

214-544-7555

Principal Investigator:

Faisal Wahid

Ogden Clinic - Canyon View

Recruiting

Ogden, Utah, United States, 84404

Contacts

385-271-0684

Principal Investigator:

Stephen Bruce

Carient Heart & Vascular - Manassas

Recruiting

Manassas, Virginia, United States, 20109

Contacts

703-335-8750

Principal Investigator:

Hamid Taheri

Carient Heart and Vascular LLC-Reston

Recruiting

Reston, Virginia, United States, 20190

Principal Investigator:

Adeeb Aghdassi

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Keywords

  • Interleukin-6 (IL-6)
  • IL-6 inhibition
  • C-reactive protein
  • Residual inflammatory risk
  • Cardiovascular risk
  • Monoclonal antibody

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-23. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-22.