AtherosclerosisPhase 2CLARITY-CRPNCT07783802
A Study of Clazakizumab (LY5724886) in Adults With Elevated hsCRP and at Increased Risk for Cardiovascular Event
A Phase 2 study testing Clazakizumab in people with Atherosclerosis and Cardiovascular Disease, run by Eli Lilly and Company at 46 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Cardiovascular Disease, Obesity
- What is being tested?
- Clazakizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 46 sitesin 4 countries
- Study dates
- 27 Aug 2026to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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)
Trial locations and contacts
46 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
46 sites in 4 countries
United States30 sites, 30 recruiting
- Recruiting
Omega Research Orlando
Altamonte Springs, Florida, 32714
386-668-4202
Kwabena Ayesu
- Recruiting
Rochester Clinical Research - Buffalo
Buffalo, New York, 14217
7164158380
Richard Carlson
- Recruiting
Velocity Clinical Research, Cincinnati, Springdale
Cincinnati, Ohio, 45246
5136718080
Charles Eger
- Recruiting
American Research Institute
Cutler Bay, Florida, 33157
Manuel Garcia Estrada
- Recruiting
Horizon Clinical Research Group
Cypress, Texas, 77429
9494910710
Fadi Alameddine
- Recruiting
Revival Research Institute, LLC
Dearborn, Michigan, 48126
Qaiser Shafiq
- Recruiting
K2 Medical Research - Foxborough
Foxborough, Massachusetts, 02035
Daniel Sacchetti
- Recruiting
Thrive Clinical Research Group
Glendora, California, 91740
626-727-7254
Fahed Bitar
- Recruiting
Cardiovascular Specialists of Willowbrook
Houston, Texas, 77070
19494910710
Aditya Samal
- Recruiting
Heart Center Research, LLC
Huntsville, Alabama, 35801
2565198472
Walter Haught
- Recruiting
Franciscan Physician Network - Indiana Heart Physicians
Indianapolis, Indiana, 46237
Anthony Bashall
- Recruiting
Texas Cardiology Associates of Houston
Kingwood, Texas, 77339
Robert Salazar
- Recruiting
Excel Clinical Research, LLC
Las Vegas, Nevada, 89109
7026801500
Robby Quintos
- Recruiting
Palm Research Center Tenaya
Las Vegas, Nevada, 89128
7027365161
Samer Nakhle
- Not yet recruiting
Accellacare - DuPage
Lombard, Illinois, 60148
Yoko Momoyama
- Recruiting
K2 Medical Research - Maitland
Maitland, Florida, 32751
407-810-2790
Neel Patel
- Recruiting
Carient Heart & Vascular - Manassas
Manassas, Virginia, 20109
7033358750
Hamid Taheri
- Recruiting
Revival Research Institute, LLC
McKinney, Texas, 75071
Asad Karim
- Recruiting
Texas Institute of Cardiology, PA
McKinney, Texas, 75071
214-544-7555
Faisal Wahid
- Recruiting
Monroe Biomedical Research - Charleston
North Charleston, South Carolina, 29406
8037662680
Gregory Feldman
- Recruiting
Ogden Clinic - Canyon View
Ogden, Utah, 84404
(385) 271-0684
Stephen Bruce
- Recruiting
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654-3514
662-893-8474
Randall Huling
- Recruiting
Florida Institute For Clinical Research, LLC
Orlando, Florida, 32825
407-658-0966
Humberto Cruz
- Recruiting
Carient Heart and Vascular LLC-Reston
Reston, Virginia, 20190
Adeeb Aghdassi
- Recruiting
CHEAR Center LLC
The Bronx, New York, 10455
13472701111
David Bernard
- Recruiting
Pima Heart
Tucson, Arizona, 85741
7176150659
Ajay Tuli
- Recruiting
Eclipse Clinical Research
Tucson, Arizona, 85745
5206479926
Eve Shapiro
- Recruiting
Suburban Research Associates
West Chester, Pennsylvania, 19380
Omer Abdullah
- Recruiting
North Georgia Clinical Research
Woodstock, Georgia, 30189
6784945735
Bram Wieskopf
- Recruiting
Cardiology Consultants of Philadelphia Yardley
Yardley, Pennsylvania, 19067
2153217400
Paul Grena
Argentina10 sites, 10 recruiting
- Not yet recruiting
CIPREC
Buenos Aires, 1061
5491144074402
Cesar Zaidman
- Not yet recruiting
Cicemo Srl
Buenos Aires, 1424
5491157417654
Pablo Costanzo
- Not yet recruiting
CARDIAMET Investigaciones Médicas
Buenos Aires, C1014ACP
5491150961905
Cecilia Reyna
- Not yet recruiting
Mautalen Salud e Investigación
Buenos Aires, C1128AAF
541145143400
Jose Fretes
- Not yet recruiting
CEMEDIC
Buenos Aires, C1407GTN
5491157506974
Facundo Lombardi
- Not yet recruiting
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, C1425AGC
541148019001
Emilio Alaguibe
- Not yet recruiting
Fundación Respirar
Buenos Aires, C1426ABP
5411 7078 1548
Marina Uhrig
- Not yet recruiting
Instituto Médico Catamarca IMEC
Rosario, 2000
3416176661
Natacha Maldonado
- Not yet recruiting
Centro de Investigaciones Clinicas del Litoral
Santa Fe, S3000FWO
5403424562779
Miguel Hominal
- Not yet recruiting
Centro de Salud e Investigaciones Médicas
Santa Rosa, L6300
542954244444
Marcos Mayer
Japan4 sites, 4 recruiting
- Not yet recruiting
Minamino Cardiovascular Hospital
Hachiōji, 192-0918
81120023812
Yoshiki Hata
- Recruiting
Takai Internal Medicine Clinic
Kamakura-shi, 247-0056
81120023812
Masahiko Takai
- Not yet recruiting
Nakakinen clinic
Naka, 311-0113
81120023812
Takeshi Osonoi
- Not yet recruiting
International University of Health and Welfare Narita Hospital
Narita, 286-8520
81120023812
Tomoya Hoshi
Puerto Rico2 sites, 2 recruiting
- Recruiting
Dorado Medical Complex
Dorado, 00646
787-278-1576
Luis Pagan-Cardona
- Recruiting
Wellness clinical Research Vega Baja
Vega Baja, 00693
787-654-9444
Gustavo Albizu Angulo
About this study
Official title: 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.
- Conditions
- Atherosclerosis, Cardiovascular Disease, Obesity, Hypertension, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
- Being tested
- Clazakizumab, Placebo
- Keywords
- Interleukin-6 (IL-6), IL-6 inhibition, C-reactive protein, Residual inflammatory risk, Cardiovascular risk, Monoclonal antibody
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases, Obesity, Hypertension, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClazakizumabDrug
Also called LY5724886
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Clazakizumab Dose 1 | Experimental | Participants will receive clazakizumab subcutaneously (SC) Receives: Drug: Clazakizumab |
| Clazakizumab Dose 2 | Experimental | Participants will receive clazakizumab SC Receives: Drug: Clazakizumab |
| Clazakizumab Dose 3 | Experimental | Participants will receive clazakizumab SC Receives: Drug: Clazakizumab |
| Placebo | Placebo comparator | Participants will receive placebo SC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline in hsCRP
Measured: Baseline, Week 12
Secondary outcomes (2)
Percent Change from Baseline in hsCRP
Measured: Baseline, Week 24
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Clazakizumab
Measured: Day 1 (Week 0) through Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start27 Aug 2026
- Primary completionMay 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783802
- Sponsor's protocol ID
- 27929
- Other IDs
- J7Y-MC-EXAA
- Acronym
- CLARITY-CRP
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07783802
- Acronym / sponsor ID
- CLARITY-CRP / 27929
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Clazakizumab Dose 1 | Experimental | Drug: ClazakizumabParticipants will receive clazakizumab subcutaneously (SC) |
| Clazakizumab Dose 2 | Experimental | Drug: ClazakizumabParticipants will receive clazakizumab SC |
| Clazakizumab Dose 3 | Experimental | Drug: ClazakizumabParticipants will receive clazakizumab SC |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo SC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- hsCRP ≥2 mg/L and ≤15 mg/L at screening
- At least one of the following chronic conditions:
Key exclusion criteria (21 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClazakizumabAlso: LY5724886Administered SC | Drug | Clazakizumab Dose 1, Clazakizumab Dose 2, Clazakizumab Dose 3 |
| PlaceboAdministered SC | Drug | Placebo |
Primary outcome
Percent Change from Baseline in hsCRP
Time frame: Baseline, Week 12
2 secondary outcomes
Percent Change from Baseline in hsCRP
Time frame: Baseline, Week 24
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Clazakizumab
Time frame: Day 1 (Week 0) through Week 32
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- A clinical trial of clazakizumab in people with high body inflammation who have atherosclerotic cardiovascular disease or are at risk of developing it (CLARITY-CRP)Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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
46 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clazakizumab in people with Atherosclerosis and Cardiovascular Disease, run by Eli Lilly and Company at 46 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Argentina, Japan, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change from Baseline in hsCRP (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.