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)

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) - J3L-MC-EZEF

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051230205

Enrollment

16700

Registered

2024-03-15

Start date

2024-03-27

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerotic Cardiovascular Disease (ASCVD) Elevated Lp(a)

Interventions

Drug: Lepodisiran Sodium Administered SC Other Name: LY3819469 Drug: Placebo Administered SC [Study Arms] Experimental: Lepodisiran Sodium Lepodisiran sodium administered subcutaneously (SC). Interven

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: -Have had a major cardiovascular event or surgery, such as myocardial infarction (MI), stroke or coronary or peripheral revascularization, =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.

Design outcomes

Primary

Measure	Time frame
Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint 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 up to End of Study (About 4.5 Years)]	—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Poland, Puerto Rico, Romania, Slovakia, South Korea, Spain, Taiwan, United Kingdom, United States

Contacts

Public ContactTrial Guide Call Center

Eli Lilly Japan K.K.

LTG_CallCenter@lists.lilly.com+81-120-023-812

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: May 22, 2026