ClinicalTrials.gg
RecruitingNCT07783802CLARITY-CRPUpdated Nov 3, 2026

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

A Phase 2 interventional study of Clazakizumab and Placebo in Atherosclerosis, Cardiovascular Disease and Obesity, sponsored by Eli Lilly and Company. Recruiting at 46 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Oct 8, 2026Site recruiting status changedEligibility revisedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Atherosclerosis
  • Cardiovascular Disease
  • Obesity
  • Hypertension
  • Diabetes Mellitus, Type 2
  • Renal Insufficiency, Chronic

Keywords

  • Interleukin-6 (IL-6)
  • IL-6 inhibition
  • C-reactive protein
  • Residual inflammatory risk
  • Cardiovascular risk
  • Monoclonal antibody
03

In context

Atherosclerosis

1,517 studies on the registry are indexed under Atherosclerosis; 224 are open to participants now.

This study's planned enrollment of 120 is above the median of 100 across 879 interventional studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.

Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Sep 30, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ( (BMI) ≥30 kg/m2)
    • Type 2 diabetes
    • Hypertension
    • Chronic kidney disease Grade 3 or 4

Exclusion criteria

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
  • 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 ≥9.0% (86 mmol/mol) at screening
  • Nephrotic syndrome, estimated (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 or infection
  • Serious, opportunistic, chronic, or recurrent infection requiring treatment within 12 weeks prior to screening
  • Significant active disease
  • Suspected or confirmed state (e.g., 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 within 14 days prior to screening
  • Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs)
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Clazakizumab Dose 1

    Participants will receive clazakizumab subcutaneously (SC)

    Drug: Clazakizumab

  • Experimental
    Clazakizumab Dose 2

    Participants will receive clazakizumab SC

    Drug: Clazakizumab

  • Experimental
    Clazakizumab Dose 3

    Participants will receive clazakizumab SC

    Drug: Clazakizumab

  • Placebo comparator
    Placebo

    Participants will receive placebo SC

    Drug: Placebo

Interventions

  • Administered SC

    Also known as: LY5724886

  • DrugPlacebo

    Administered SC

06

What researchers measure

Primary outcomes

  1. Percent Change from Baseline in hsCRP

    Time frame: Baseline, Week 12

Secondary outcomes

  1. Percent Change from Baseline in hsCRP

    Time frame: Baseline, Week 24

  2. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Clazakizumab

    Time frame: Day 1 (Week 0) through Week 32

07

Study locations

32 of 46 sites recruiting
  • Heart Center Research, LLC
    Huntsville, Alabama 35801, United States
    Recruiting
    • · Contact2565198472
    • Walter Haught · Principal investigator
  • Pima Heart
    Tucson, Arizona 85741, United States
    Recruiting
    • · Contact7176150659
    • Ajay Tuli · Principal investigator
  • Eclipse Clinical Research
    Tucson, Arizona 85745, United States
    Recruiting
    • · Contact5206479926
    • Eve Shapiro · Principal investigator
  • Thrive Clinical Research Group
    Glendora, California 91740, United States
    Recruiting
    • · Contact626-727-7254
    • Fahed Bitar · Principal investigator
  • Omega Research Orlando
    Altamonte Springs, Florida 32714, United States
    Recruiting
    • · Contact386-668-4202
    • Kwabena Ayesu · Principal investigator
  • American Research Institute
    Cutler Bay, Florida 33157, United States
    Recruiting
    • Manuel Garcia Estrada · Principal investigator
  • K2 Medical Research - Maitland
    Maitland, Florida 32751, United States
    Recruiting
    • · Contact407-810-2790
    • Neel Patel · Principal investigator
  • Florida Institute For Clinical Research, LLC
    Orlando, Florida 32825, United States
    Recruiting
    • · Contact407-658-0966
    • Humberto Cruz · Principal investigator
  • North Georgia Clinical Research
    Woodstock, Georgia 30189, United States
    Recruiting
    • · Contact6784945735
    • Bram Wieskopf · Principal investigator
  • Accellacare - DuPage
    Lombard, Illinois 60148, United States
    Not yet recruiting
    • Yoko Momoyama · Principal investigator
  • Franciscan Physician Network - Indiana Heart Physicians
    Indianapolis, Indiana 46237, United States
    Recruiting
    • Anthony Bashall · Principal investigator
  • K2 Medical Research - Foxborough
    Foxborough, Massachusetts 02035, United States
    Recruiting
    • Daniel Sacchetti · Principal investigator
  • Revival Research Institute, LLC
    Dearborn, Michigan 48126, United States
    Recruiting
    • Qaiser Shafiq · Principal investigator
  • Olive Branch Family Medical Center
    Olive Branch, Mississippi 38654-3514, United States
    Recruiting
    • · Contact662-893-8474
    • Randall Huling · Principal investigator
  • Excel Clinical Research, LLC
    Las Vegas, Nevada 89109, United States
    Recruiting
    • · Contact7026801500
    • Robby Quintos · Principal investigator
  • Palm Research Center Tenaya
    Las Vegas, Nevada 89128, United States
    Recruiting
    • · Contact7027365161
    • Samer Nakhle · Principal investigator
  • Rochester Clinical Research - Buffalo
    Buffalo, New York 14217, United States
    Recruiting
    • · Contact7164158380
    • Richard Carlson · Principal investigator
  • CHEAR Center LLC
    The Bronx, New York 10455, United States
    Recruiting
    • · Contact13472701111
    • David Bernard · Principal investigator
  • Velocity Clinical Research, Cincinnati, Springdale
    Cincinnati, Ohio 45246, United States
    Recruiting
    • · Contact5136718080
    • Charles Eger · Principal investigator
  • Suburban Research Associates
    West Chester, Pennsylvania 19380, United States
    Recruiting
    • Omer Abdullah · Principal investigator
  • Cardiology Consultants of Philadelphia Yardley
    Yardley, Pennsylvania 19067, United States
    Recruiting
    • · Contact2153217400
    • Paul Grena · Principal investigator
  • Monroe Biomedical Research - Charleston
    North Charleston, South Carolina 29406, United States
    Recruiting
    • · Contact8037662680
    • Gregory Feldman · Principal investigator
  • Horizon Clinical Research Group
    Cypress, Texas 77429, United States
    Recruiting
    • · Contact9494910710
    • Fadi Alameddine · Principal investigator
  • Cardiovascular Specialists of Willowbrook
    Houston, Texas 77070, United States
    Recruiting
    • · Contact19494910710
    • Aditya Samal · Principal investigator
  • Texas Cardiology Associates of Houston
    Kingwood, Texas 77339, United States
    Recruiting
    • Robert Salazar · Principal investigator
  • Revival Research Institute, LLC
    McKinney, Texas 75071, United States
    Recruiting
    • Asad Karim · Principal investigator
  • Texas Institute of Cardiology, PA
    McKinney, Texas 75071, United States
    Recruiting
    • · Contact214-544-7555
    • Faisal Wahid · Principal investigator
  • Ogden Clinic - Canyon View
    Ogden, Utah 84404, United States
    Recruiting
    • · Contact(385) 271-0684
    • Stephen Bruce · Principal investigator
  • Carient Heart & Vascular - Manassas
    Manassas, Virginia 20109, United States
    Recruiting
    • · Contact7033358750
    • Hamid Taheri · Principal investigator
  • Carient Heart and Vascular LLC-Reston
    Reston, Virginia 20190, United States
    Recruiting
    • Adeeb Aghdassi · Principal investigator
  • CIPREC
    Buenos Aires, 1061, Argentina
    Not yet recruiting
    • · Contact5491144074402
    • Cesar Zaidman · Principal investigator
  • Cicemo Srl
    Buenos Aires, 1424, Argentina
    Not yet recruiting
    • · Contact5491157417654
    • Pablo Costanzo · Principal investigator
  • CARDIAMET Investigaciones Médicas
    Buenos Aires, C1014ACP, Argentina
    Not yet recruiting
    • · Contact5491150961905
    • Cecilia Reyna · Principal investigator
  • Mautalen Salud e Investigación
    Buenos Aires, C1128AAF, Argentina
    Not yet recruiting
    • · Contact541145143400
    • Jose Fretes · Principal investigator
  • CEMEDIC
    Buenos Aires, C1407GTN, Argentina
    Not yet recruiting
    • · Contact5491157506974
    • Facundo Lombardi · Principal investigator
  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
    Buenos Aires, C1425AGC, Argentina
    Not yet recruiting
    • · Contact541148019001
    • Emilio Alaguibe · Principal investigator
  • Fundación Respirar
    Buenos Aires, C1426ABP, Argentina
    Not yet recruiting
    • · Contact5411 7078 1548
    • Marina Uhrig · Principal investigator
  • Instituto Médico Catamarca IMEC
    Rosario, 2000, Argentina
    Not yet recruiting
    • · Contact3416176661
    • Natacha Maldonado · Principal investigator
  • Centro de Investigaciones Clinicas del Litoral
    Santa Fe, S3000FWO, Argentina
    Not yet recruiting
    • · Contact5403424562779
    • Miguel Hominal · Principal investigator
  • Centro de Salud e Investigaciones Médicas
    Santa Rosa, L6300, Argentina
    Not yet recruiting
    • · Contact542954244444
    • Marcos Mayer · Principal investigator
  • Minamino Cardiovascular Hospital
    Hachiōji, 192-0918, Japan
    Not yet recruiting
    • · Contact81120023812
    • Yoshiki Hata · Principal investigator
  • Takai Internal Medicine Clinic
    Kamakura-shi, 247-0056, Japan
    Recruiting
    • · Contact81120023812
    • Masahiko Takai · Principal investigator
  • Nakakinen clinic
    Naka, 311-0113, Japan
    Not yet recruiting
    • · Contact81120023812
    • Takeshi Osonoi · Principal investigator
  • International University of Health and Welfare Narita Hospital
    Narita, 286-8520, Japan
    Not yet recruiting
    • · Contact81120023812
    • Tomoya Hoshi · Principal investigator
  • Dorado Medical Complex
    Dorado, 00646, Puerto Rico
    Recruiting
    • · Contact787-278-1576
    • Luis Pagan-Cardona · Principal investigator
  • Wellness clinical Research Vega Baja
    Vega Baja, 00693, Puerto Rico
    Recruiting
    • · Contact787-654-9444
    • Gustavo Albizu Angulo · Principal investigator
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

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.

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

Data sharing details ↗ · vivli.org

09

Updates

3 registry updates since Sep 25, 2026
Sites
7 sites changed recruiting status (7 now recruiting)
Show 7 sites
  • Pima Heart · Tucson, United StatesNot yet recruiting→Recruiting
  • K2 Medical Research - Maitland · Maitland, United StatesNot yet recruiting→Recruiting
  • Franciscan Physician Network - Indiana Heart Physicians · Indianapolis, United StatesNot yet recruiting→Recruiting
  • Rochester Clinical Research - Buffalo · Buffalo, United StatesNot yet recruiting→Recruiting
  • CHEAR Center LLC · The Bronx, United StatesNot yet recruiting→Recruiting
  • Texas Cardiology Associates of Houston · Kingwood, United StatesNot yet recruiting→Recruiting
  • Takai Internal Medicine Clinic · Kamakura-shi, JapanNot yet recruiting→Recruiting
Oct 8, 2026
Eligibility
1 exclusion criterion edited
What changed in the criteria
Exclusion criteria
  • EditedHistory of symptomatic diverticular disease (diverticulitis), gastrointestinal perforation, or major gastrointestinal surgery
Sep 30, 2026
Site contacts
Changed at 2 sites. See the sites
Show 2 sites
  • CHEAR Center LLC · The Bronx, United StatesContact •••1111→•••1111
  • Cardiovascular Specialists of Willowbrook · Houston, United StatesContact •••0710→•••0710
across 3 updates, Sep 30, 2026 – Nov 3, 2026
Show all 3 updates
  1. Nov 3, 2026
    Site contacts Changed at 2 sites. See the sites
    Show 2 sites
    • CHEAR Center LLC · The Bronx, United StatesContact •••1111→•••1111
    • Cardiovascular Specialists of Willowbrook · Houston, United StatesContact •••0710→•••0710
    + 1 other change: references
  2. Oct 8, 2026
    7 sites changed recruiting status (7 now recruiting)
    Show 7 sites
    • Pima Heart · Tucson, United StatesNot yet recruiting→Recruiting
    • K2 Medical Research - Maitland · Maitland, United StatesNot yet recruiting→Recruiting
    • Franciscan Physician Network - Indiana Heart Physicians · Indianapolis, United StatesNot yet recruiting→Recruiting
    • Rochester Clinical Research - Buffalo · Buffalo, United StatesNot yet recruiting→Recruiting
    • CHEAR Center LLC · The Bronx, United StatesNot yet recruiting→Recruiting
    • Texas Cardiology Associates of Houston · Kingwood, United StatesNot yet recruiting→Recruiting
    • Takai Internal Medicine Clinic · Kamakura-shi, JapanNot yet recruiting→Recruiting
    Site contacts Changed at 2 sites. See the sites
    Show 2 sites
    • CHEAR Center LLC · The Bronx, United StatesContact •••1111→•••1111
    • Cardiovascular Specialists of Willowbrook · Houston, United StatesContact •••0710→•••0710
    + 1 other change: verification date
  3. Sep 30, 2026
    Eligibility 1 exclusion criterion edited
    What changed in the criteria
    Exclusion criteria
    • EditedHistory of symptomatic diverticular disease (diverticulitis), gastrointestinal perforation, or major gastrointestinal surgery
    Site contacts Changed at 2 sites. See the sites
    Show 2 sites
    • CHEAR Center LLC · The Bronx, United StatesContact •••1111→•••1111
    • Cardiovascular Specialists of Willowbrook · Houston, United StatesContact •••0710→•••0710

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07783802
Responsible party
Sponsor
First posted
Aug 25, 2026
Start date
Aug 27, 2026
Primary completion
May 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Clazakizumab

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