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Investigating lepodisiran for reducing cardiovascular events in patients with high lipoprotein(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)

Phase 3 Interventional Eli Lilly and Company · NCT06292013

This study tests if a new medication called lepodisiran can lower the risk of serious heart problems in adults with high levels of lipoprotein(a).

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment12500 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations977 sites (Birmingham, Alabama and 976 other locations)
Trial IDNCT06292013 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of lepodisiran, a medication administered subcutaneously, in lowering the risk of major adverse cardiovascular events in adults with elevated lipoprotein(a) levels. Participants include those with established atherosclerotic cardiovascular disease or individuals at high risk for cardiovascular events. The study aims to determine if lepodisiran can significantly reduce cardiovascular risks compared to a placebo. It is a Phase 3 interventional trial, indicating a focus on confirming efficacy and safety in a larger population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with elevated lipoprotein(a) levels and either established atherosclerotic cardiovascular disease or those at high risk for cardiovascular events.

Not a fit: Patients who have had a major cardiovascular event or surgery within the last 60 days or those with uncontrolled hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of heart attacks and strokes in patients with elevated lipoprotein(a).

How similar studies have performed: Other studies targeting elevated lipoprotein(a) have shown promise, but this specific approach with lepodisiran is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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:

* 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 this trial is running

Birmingham, Alabama and 976 other locations

+927 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atherosclerotic Cardiovascular DiseaseElevated LpASCVDLY3819469lepodisiran
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.