Lepodisiran Sodium
DrugAdministered SC
Other names: LY3819469
NCT Number: NCT06292013
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 3
Clínica Privada del Prado SRL, Alberdi, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Administered SC
Other names: LY3819469
Administered SC
Time frame: Baseline up to End of Study (About 4.5 Years)
Time to first event in a MACE-4 composite endpoint, comprised of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent coronary revascularization.
Time frame: Baseline, Week 4
Change from Baseline in Lp(a)
Time frame: Baseline up to End of Study (About 4.5 Years)
Time to first occurrence MACE-3
Time frame: Baseline up to End of Study (About 4.5 Years)
Time to first occurrence of fatal or non-fatal myocardial infarction.
Time frame: Baseline up to End of Study (About 4.5 Years)
Time to cardiovascular death.
Time frame: Baseline up to End of Study (About 4.5 Years)
Time to occurrence of all-cause death
Time frame: Baseline up to End of Study (About 4.5 Years)
Time to first occurrence of any component of the MACE-4 composite endpoint.
Time frame: Baseline up to End of Study (About 4.5 Years)
Time to first occurrence of any component of the MACE-4 composite endpoint.
Time frame: Baseline up to End of Study (About 4.5 Years)
Time to first occurrence of any component of the MACE-4 composite endpoint.
Time frame: Baseline up to End of Study (About 4.5 Years)
Time to first occurrence of any component of MACE-3 + MALE composite endpoint.
Time frame: Baseline up to End of Study (About 4.5 Years)
Time to first Occurrence of any component of coronary MACE-3 composite endpoint.
Eli Lilly and Company
Industry
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) Who Have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event - ACCLAIM-Lp(a)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06383390
Arterial Occlusive Diseases, Arteriosclerosis
Alabaster, Alabama, United States
View Trial DetailsNCT07315997
Arterial Occlusive Diseases, Arteriosclerosis
Boston, Massachusetts, United States
View Trial DetailsNCT07654231
Arterial Occlusive Diseases, Arteriosclerosis
Dallas, Texas, United States
View Trial DetailsNCT07581808
Arterial Occlusive Diseases, Arteriosclerosis
Ljubljana, Slovenia
View Trial Details