A Study of Clazakizumab (LY5724886) in Adults With Elevated hsCRP and at Increased Risk for Cardiovascular Event (CLARITY-CRP)

August 21, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ABP
        • Fundación Respirar
        • Principal Investigator:
          • Marina Uhrig
        • Contact:
          • Phone Number: 5411 7078 1548
      • Buenos Aires, Argentina, C1407GTN
        • CEMEDIC
        • Contact:
          • Phone Number: 5491157506974
        • Principal Investigator:
          • Facundo Lombardi
      • Buenos Aires, Argentina, 1061
        • CIPREC
        • Contact:
          • Phone Number: 5491144074402
        • Principal Investigator:
          • Cesar Zaidman
      • Buenos Aires, Argentina, C1425AGC
        • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
        • Contact:
          • Phone Number: 541148019001
        • Principal Investigator:
          • Emilio Alaguibe
      • Buenos Aires, Argentina, C1128AAF
        • Mautalen Salud e investigación
        • Contact:
          • Phone Number: 541145143400
        • Principal Investigator:
          • Jose Fretes
      • Buenos Aires, Argentina, 1424
        • Cicemo Srl
        • Contact:
          • Phone Number: 5491157417654
        • Principal Investigator:
          • Pablo Costanzo
      • Buenos Aires, Argentina, C1014ACP
        • CARDIAMET Investigaciones Médicas
        • Contact:
          • Phone Number: 5491150961905
        • Principal Investigator:
          • Cecilia Reyna
      • Rosario, Argentina, 2000
        • Instituto Médico Catamarca IMEC
        • Contact:
          • Phone Number: 3416176661
        • Principal Investigator:
          • Natacha Maldonado
      • Santa Fe, Argentina, S3000FWO
        • Centro de Investigaciones Clinicas del Litoral
        • Contact:
          • Phone Number: 5403424562779
        • Principal Investigator:
          • Miguel Hominal
      • Santa Rosa, Argentina, L6300
        • Centro de Salud e Investigaciones Médicas
        • Contact:
          • Phone Number: 542954244444
        • Principal Investigator:
          • Marcos Mayer
  • Japan
      • Hachiōji, Japan, 192-0918
        • Minamino Cardiovascular Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yoshiki Hata
      • Kamakura-shi, Japan, 247-0056
        • Takai Internal Medicine Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masahiko Takai
      • Naka, Japan, 311-0113
        • Nakakinen clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Takeshi Osonoi
      • Narita, Japan, 286-8520
        • International University of Health and Welfare Narita Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tomoya Hoshi
  • Puerto Rico
      • Dorado, Puerto Rico, 00646
        • Dorado Medical Complex
        • Principal Investigator:
          • Luis Pagan-Cardona
        • Contact:
          • Phone Number: 787-278-1576
      • Vega Baja, Puerto Rico, 00693
        • Wellness clinical Research Vega Baja
        • Principal Investigator:
          • Gustavo Albizu Angulo
        • Contact:
          • Phone Number: 787-654-9444
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research, LLC
        • Contact:
          • Phone Number: 2565198472
        • Principal Investigator:
          • Walter Haught
    • Arizona
      • Tucson, Arizona, United States, 85745
        • Eclipse Clinical Research
        • Principal Investigator:
          • Eve Shapiro
        • Contact:
          • Phone Number: 5206479926
      • Tucson, Arizona, United States, 85741
        • Pima Heart
        • Principal Investigator:
          • Ajay Tuli
        • Contact:
          • Phone Number: 7176150659
    • California
      • Glendora, California, United States, 91740
        • Thrive Clinical Research Group
        • Principal Investigator:
          • Fahed Bitar
        • Contact:
          • Phone Number: 626-727-7254
    • Florida
      • Altamonte Springs, Florida, United States, 32714
        • Omega Research Orlando
        • Principal Investigator:
          • Kwabena Ayesu
        • Contact:
          • Phone Number: 386-668-4202
      • Cutler Bay, Florida, United States, 33157
        • American Research Institute
        • Principal Investigator:
          • Manuel Garcia Estrada
      • Maitland, Florida, United States, 32751
        • K2 Medical Research - Maitland
        • Contact:
          • Phone Number: 407-810-2790
        • Principal Investigator:
          • Neel Patel
      • Orlando, Florida, United States, 32825
        • Florida Institute For Clinical Research, LLC
        • Contact:
          • Phone Number: 407-658-0966
        • Principal Investigator:
          • Humberto Cruz
    • Georgia
      • Woodstock, Georgia, United States, 30189
        • North Georgia Clinical Research
        • Principal Investigator:
          • Bram Wieskopf
        • Contact:
          • Phone Number: 6784945735
    • Illinois
      • Lombard, Illinois, United States, 60148
        • Accellacare - DuPage
        • Principal Investigator:
          • Yoko Momoyama
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Franciscan Physician Network - Indiana Heart Physicians
        • Principal Investigator:
          • Anthony Bashall
    • Massachusetts
      • Foxborough, Massachusetts, United States, 02035
        • K2 Medical Research - Foxborough
        • Principal Investigator:
          • Daniel Sacchetti
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Revival Research Institute, LLC
        • Principal Investigator:
          • Qaiser Shafiq
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654-3514
        • Olive Branch Family Medical Center
        • Principal Investigator:
          • Randall Huling
        • Contact:
          • Phone Number: 662-893-8474
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Palm Research Center Tenaya
        • Principal Investigator:
          • Samer Nakhle
        • Contact:
          • Phone Number: 7027365161
      • Las Vegas, Nevada, United States, 89109
        • Excel Clinical Research, LLC
        • Principal Investigator:
          • Robby Quintos
        • Contact:
          • Phone Number: 7026801500
    • New York
      • Buffalo, New York, United States, 14217
        • Rochester Clinical Research - Buffalo
        • Contact:
          • Phone Number: 7164158380
        • Principal Investigator:
          • Richard Carlson
      • The Bronx, New York, United States, 10455
        • CHEAR Center LLC
        • Contact:
          • Phone Number: 13472701111
        • Principal Investigator:
          • David Bernard
    • North Dakota
      • Grand Forks, North Dakota, United States, 58201
        • Altru Health System
        • Principal Investigator:
          • Puvanalingam Ayyadurai
    • Ohio
      • Cincinnati, Ohio, United States, 45246
        • Velocity Clinical Research, Cincinnati, Springdale
        • Principal Investigator:
          • Charles Eger
        • Contact:
          • Phone Number: 5136718080
    • Pennsylvania
      • West Chester, Pennsylvania, United States, 19380
        • Suburban Research Associates
        • Principal Investigator:
          • Omer Abdullah
      • Yardley, Pennsylvania, United States, 19067
        • Cardiology Consultants of Philadelphia Yardley
        • Principal Investigator:
          • Paul Grena
        • Contact:
          • Phone Number: 2153217400
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Monroe Biomedical Research - Charleston
        • Principal Investigator:
          • Gregory Feldman
        • Contact:
          • Phone Number: 8037662680
    • Texas
      • Cypress, Texas, United States, 77429
        • Horizon Clinical Research Group
        • Principal Investigator:
          • Fadi Alameddine
        • Contact:
          • Phone Number: 9494910710
      • Houston, Texas, United States, 77070
        • Cardiovascular Specialists of Willowbrook
        • Principal Investigator:
          • Aditya Samal
        • Contact:
          • Phone Number: 19494910710
      • Kingwood, Texas, United States, 77339
        • Texas Cardiology Associates of Houston
        • Principal Investigator:
          • Robert Salazar
      • McKinney, Texas, United States, 75071
        • Texas Institute of Cardiology, PA
        • Contact:
          • Phone Number: 214-544-7555
        • Principal Investigator:
          • Faisal Wahid
      • McKinney, Texas, United States, 75071
        • Revival Research Institute, LLC
        • Principal Investigator:
          • Asad Karim
    • Utah
      • Ogden, Utah, United States, 84404
        • Ogden Clinic - Canyon View
        • Principal Investigator:
          • Stephen Bruce
        • Contact:
          • Phone Number: (385) 271-0684
    • Virginia
      • Manassas, Virginia, United States, 20109
        • Carient Heart & Vascular - Manassas
        • Principal Investigator:
          • Hamid Taheri
        • Contact:
          • Phone Number: 7033358750
      • Reston, Virginia, United States, 20190
        • Carient Heart and Vascular LLC-Reston
        • Principal Investigator:
          • Adeeb Aghdassi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo SC
Drug: Placebo
Administered SC
Experimental: Clazakizumab Dose 1
Participants will receive clazakizumab subcutaneously (SC)
Drug: Clazakizumab
Administered SC
Other Names:
  • LY5724886
Experimental: Clazakizumab Dose 2
Participants will receive clazakizumab SC
Drug: Clazakizumab
Administered SC
Other Names:
  • LY5724886
Experimental: Clazakizumab Dose 3
Participants will receive clazakizumab SC
Drug: Clazakizumab
Administered SC
Other Names:
  • LY5724886

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in hsCRP
Time Frame: Baseline, Week 12
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in hsCRP
Time Frame: Baseline, Week 24
Baseline, Week 24
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Clazakizumab
Time Frame: Day 1 (Week 0) through Week 32
Day 1 (Week 0) through Week 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

August 21, 2026

First Submitted That Met QC Criteria

August 21, 2026

First Posted (Actual)

August 25, 2026

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27929
  • J7Y-MC-EXAA (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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