Clazakizumab to Lower Inflammation in Adults at Risk of Heart Disease Events
Tests clazakizumab against placebo for lowering inflammation in adults at heart risk.
Plain-language title generated from the registry record
Registry title: A Study of Clazakizumab (LY5724886) in Adults With Elevated hsCRP and at Increased Risk for Cardiovascular Event
Key facts
- Where
- Hachiōji, Kamakura-shi, Naka, and Narita, JapanSee the 4 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with raised hsCRP, a blood marker of inflammation, who have heart and blood vessel disease or are at higher risk of it.
- Age
- 18 years or older
- Sex
- Women and men can join.
- Disease stage
- At least one of these: established atherosclerotic cardiovascular disease, obesity (BMI ≥30 kg/m2), type 2 diabetes, hypertension, or chronic kidney disease Grade 3 or 4.
- Earlier treatment
- Cannot have used colchicine within 14 days, systemic corticosteroids within 14 days, or immunosuppressive or immunomodulatory drugs (including other anti-IL-6 biologics) within specified windows. Cannot be on chronic NSAIDs.
- Biomarker or test result
- hsCRP ≥2 mg/L and ≤15 mg/L at screening.
Main reasons for not taking part
- Acute cardiovascular event or acute decompensated heart failure hospitalization within 60 days before screening
- New York Heart Association Class III or IV heart failure
- Type 1 diabetes, or type 2 diabetes with Hemoglobin A1c ≥9.0% (75 mmol/mol)
- Dialysis, kidney transplant, or eGFR <15 mL/min/1.73 m²
- Active tuberculosis, hepatitis B or C, or a weakened immune system such as HIV infection
Read by machine on 9 November 2026.
Where in Japan
- Minamino Cardiovascular HospitalHachiōji, JapanNot yet recruiting
- Takai Internal Medicine ClinicKamakura-shi, JapanTaking people
- Nakakinen clinicNaka, JapanNot yet recruiting
- International University of Health and Welfare Narita HospitalNarita, JapanNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07783802
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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; Dialysis or acute kidney injury within 60 days prior to screening; Serious, opportunistic, chronic, or recurrent infection requiring treatment within 12 weeks prior to screening; History of peptic ulcer disease or gastrointestinal ulceration within 12 months prior to screening; 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); 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; 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; Significant active autoimmune disease; Suspected or confirmed immunocompromised state (e.g., HIV infection); History of symptomatic diverticular disease (diverticulitis), gastrointestinal perforation, or major gastrointestinal surgery; Mechanical heart valve prosthesis requiring chronic vitamin K antagonist anticoagulation; 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.