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Recruiting
NCT07783802
A Study of Clazakizumab (LY5724886) in Adults With Elevated hsCRP and at Increased Risk for Cardiovascular Event
Conditions: Atherosclerosis, Cardiovascular Disease, Obesity, Hypertension, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 120
Sponsor: Eli Lilly and Company
Location: Heart Center Research, LLC Huntsville Alabama
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.
Eligibility Criteria
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) \
Source: ClinicalTrials.gov (NCT07783802). StuddyBuddy aggregates publicly available trial information.