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A Study of Lepodisiran for Plaque Reduction in Adults with High Lp(a)

This study is looking at how a drug called lepodisiran might help reduce plaque in the heart's arteries for adults aged 45 to 80. You could be eligible if you have high levels of Lipoprotein(a) (Lp(a)), which is a protein linked to a higher risk of heart disease, and have either had heart events or are at high risk. Researchers will compare lepodisiran to a placebo (an inactive substance) to see how it affects the amount and type of plaque using a special imaging scan (Coronary Computed Tomography Angiography or CCTA). The main goal is to measure changes in noncalcified plaque volume over about 104 weeks. The study aims to enroll 252 participants.

Study design
This interventional study is designed to compare lepodisiran to a placebo. It plans to enroll 252 participants.
What's involved
Participation in this study will last about 120 weeks. You would receive either lepodisiran or a placebo, both given as an injection under the skin (SC).
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes in plaque volume at Week 104, suggesting follow-up for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07613294

A Study to See if Lepodisiran Can Reduce Plaque in Coronary Arteries of Adults With Elevated Lp(a) Who Have Had Heart Events or Are at High Risk

Recruiting
PHASE3Ages 45–80InterventionalTreatment
Eli Lilly and Company
~252 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:LepodisiranPlacebo

At a glance

Recruiting sites
28 of 58 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent Change from Baseline in Noncalcified Plaque (NCP) Volume
Measured over Baseline, Week 104

Conditions

Atherosclerosis
Cardiovascular Diseases
Lipoprotein(a)

Explore related trials

AtherosclerosisCoronary Artery Disease

Where it's being run

58 sites across 16 states
Australia10
Spain10
United Kingdom10
Florida5
Czechia4
Netherlands4
California3
Hungary3

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Have an Lp(a) ≥175 nmol/L
Have established cardiovascular (CV) disease or are at risk for a first CV event
Have angiographic evidence of coronary artery disease on screening CCTA
If taking lipid-lowering medications, inclusive of statins or prescription strength niacin and PCSK9 inhibitors, these should be stable for 8 weeks

Exclusion

Have had a major CV event less than 60 days before measurement of the Lp(a) level used for eligibility or uncontrolled high blood pressure at screening
Have moderate to severe renal dysfunction
Have severe heart failure
Have a history of coronary artery bypass graft surgery (CABG)
Have a planned coronary angiography, percutaneous coronary intervention (PCI), coronary artery bypass graft, or valvular intervention
Have had a procedure to remove lipoproteins from the blood or received therapy specifically targeting Lp(a)
Are unable to safely undergo CCTA due to medication intolerance, contrast allergies, or anatomical/technical factors

What this trial measures

  • Percent Change from Baseline in Noncalcified Plaque (NCP) VolumeBaseline, Week 104