A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)
Study Phase: Phase 3
Recruitment Status: Recruiting
Start Date: March 05, 2024
End Date: March 01, 2029
Physicians interested in becoming principal investigators please contact
Inclusion Criteria:
- Have Lipoprotein(a) [Lp(a)] ≥175 nanomoles per liter (nmol/L).
- Meet criteria of either 2a or 2b: 2a: Individuals 18 years of age or older with established atherosclerotic cardiovascular disease (ASCVD) with an event or revascularization. 2b: Individuals 55 years of age or older who are at risk for a first cardiovascular (CV) event and either: Documented coronary artery disease (CAD), carotid stenosis, or peripheral artery disease (PAD) without history of event or revascularization; known familial hypercholesteremia; or a combination of high-risk factors.
Exclusion Criteria:
- Have had a major cardiovascular event or surgery, such as myocardial infarction (MI), stroke or coronary or peripheral revascularization, < 60 days before screening
- Have uncontrolled hypertension
- Have New York Heart Association class IV heart failure.
- Have lipoprotein apheresis within 90 days of screening, or planned lipoprotein apheresis during the study.
- Have severe renal failure, defined as
- Estimated glomerular rate (eGFR) <15 milliliters per minute per 1.73 meters squared (mL/min/1.73m2) at screening Visit 1, or ongoing dialysis.
- Have a diagnosis of active nephrotic syndrome, or urine albumin-creatinine ratio (UACR) of ≥5000 mg/g at screening Visit 1.
- Have acute or chronic hepatitis, known cirrhosis, signs and symptoms of any other liver disease other than metabolic-associated steatotic liver disease, or exclusionary laboratory results as determined by the central laboratory during screening.
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Conditions:
- Atherosclerosis