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)
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Atherosclerotic Cardiovascular Disease (ASCVD), Elevated Lp(a)
In brief
The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. The study drug will be administered subcutaneously (SC) (under the skin). Approximately 1700 additional participants will be enrolled in an addendum to explore Lp(a) lowering with an alternative dosing schema.
Key facts
- Study ID
- NCT06292013
- Run by
- Eli Lilly and Company
- People needed
- 17300
- Starts
- 2024-03-05
- Expected to finish
- 2029-03-01
- Last updated by the study team
- 2026-07-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Alliance for Multispecialty Research, LLC — Daphne, Alabama, United States
- SEC Clinical Research — Dothan, Alabama, United States
- Alliance for Multispecialty Research, LLC — Mobile, Alabama, United States
- Mobile Heart Specialists — Mobile, Alabama, United States
- Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC — Gilbert, Arizona, United States
- Mercy Gilbert Medical Center — Gilbert, Arizona, United States
- Sun City Clinical Research — Glendale, Arizona, United States
- Elite Clinical Studies, LLC — Phoenix, Arizona, United States
- Helios Clinical Research - Phoenix — Phoenix, Arizona, United States
- Absolute Clinical Research — Phoenix, Arizona, United States
- Clinical Research Institute of Arizona (CRI) - Sun City West — Sun City West, Arizona, United States
- Pima Heart — Tucson, Arizona, United States
- Synexus Clinical Research US, Inc./Orange Grove Family Practice — Tucson, Arizona, United States
- Eclipse Clinical Research — Tucson, Arizona, United States
- Cardiology and Medicine Clinic — Little Rock, Arkansas, United States
- National Heart Institute — Beverly Hills, California, United States
- Valley Clinical Trials, Inc. — Covina, California, United States
- Neighborhood Healthcare Institute of Health — Escondido, California, United States
- HB Clinical Trials - Fountain Valley — Fountain Valley, California, United States
- Care Access - Huntington Beach — Huntington Beach, California, United States
- 310 Clinical Research — Inglewood, California, United States
- UCSD - Altman Clinical and Translational Research Institute (ACTRI) — La Jolla, California, United States
- Scripps Whittier Diabetes Institute — La Jolla, California, United States
- First Valley Medical Group — Lancaster, California, United States
- Birmingham Clinical Research — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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