RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Eli Lilly and Company • ClinicalTrials.gov ID: NCT07613294

Registry updated: 2026-10-08

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Description

Lipoprotein(a), also known as Lp(a), is a protein that carries cholesterol and proteins in your blood. People with high Lp(a) have a higher risk for heart disease. The main purpose of the study is to investigate how lepodisiran, compared to a placebo, affects the amount and type of plaque in the heart's vessels using an imaging technology known as Coronary Computed Tomography Angiography (CCTA) in adults who have high levels of Lp(a). Participation will last about 120 weeks.

Interventions

Lepodisiran (Drug)
Administered SC
Placebo (Drug)
Administered SC

Eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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

Conditions

Atherosclerosis Cardiovascular Diseases Lipoprotein(a)

Locations

UCSD - Altman Clinical and Translational Research Institute (ACTRI) — La Jolla, California, United States
Valley Clinical Trials, Inc. — Northridge, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States
Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care — Fort Lauderdale, Florida, United States
Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
Merritt Island Medical Research, LLC — Merritt Island, Florida, United States
Inpatient Research Clinic — Miami Lakes, Florida, United States
Clinical Site Partners, LLC dba Flourish Research — Winter Park, Florida, United States
High Desert Heart & Vascular — Meridian, Idaho, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Profound Research LLC — Farmington Hills, Michigan, United States
Vector Clinical Trials — Las Vegas, Nevada, United States
Heart and Vascular Research at WellSpan Health — York, Pennsylvania, United States
Intermountain Medical Center — Murray, Utah, United States
Virginia Heart — Falls Church, Virginia, United States
Carilion Clinic — Roanoke, Virginia, United States
Eastside Research Associates — Redmond, Washington, United States
Nightingale Research — Adelaide, Australia
University of the Sunshine Coast (UniSC) Clinical Trials - Birtinya — Birtinya, Australia
Core Research Group — Brisbane, Australia
Advara HeartCare - Burwood — Burwood, Australia
Advara HeartCare Joondalup — Joondalup, Australia
Advara HeartCare Leabrook — Leabrook, Australia
AIM Research — Merewether, Australia
Advara HeartCare - Mulgrave — Mulgrave, Australia
USC Clinical Trials Brisbane (South Bank) — South Brisbane, Australia
Clinitrials — West Perth, Australia
Fakultni Nemocnice u sv. Anny v Brne — Brno, Czechia
EFERTUS healthcare s.r.o. — Brno, Czechia
Top Moravia Health — Brno, Czechia
Fakultni Nemocnice u sv. Anny v Brne — Brno, Czechia
Óbudai Egészségügyi Centrum — Budapest, Hungary
Semmelweis University — Budapest, Hungary
Szabolcs Szatmár Bereg Vármegyei Oktatókórház — Nyíregyháza, Hungary
Medisch Spectrum Twente — Enschede, Netherlands
Ziekenhuis St. Jansdal — Harderwijk, Netherlands
Alrijne Ziekenhuis, locatie Leiderdorp — Leiderdorp, Netherlands
VieCuri Medisch Centrum, locatie Venlo — Venlo, Netherlands
CHUAC-Complejo Hospitalario Universitario A Coruña — A Coruña, Spain
Parc de Salut Mar - Hospital del Mar — Barcelona, Spain
Hospital Quiron Barcelona — Barcelona, Spain
Hospital Universitario Reina Sofia — Córdoba, Spain
Hospital Insular de Gran Canaria — Las Palmas de Gran Canaria, Spain
Hospital Universitario Ramón y Cajal — Madrid, Spain
Hospital Clinico San Carlos — Madrid, Spain
Hospital Universitario Virgen Macarena — Seville, Spain
Hospital Universitario Virgen Del Rocio — Seville, Spain
Hospital General Universitario de Valencia — Valencia, Spain
FutureMeds - Birmingham — Birmingham, United Kingdom
Bristol Royal Infirmary — Bristol, United Kingdom
Cheadle Community Hospital — Cheadle, United Kingdom
Royal Lancaster Infirmary — Lancaster, United Kingdom
Lincoln County Hospital — Lincoln, United Kingdom
Futuremeds-Newcastle — Newcastle, United Kingdom
The John Radcliffe Hospital — Oxford, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield, United Kingdom
Lister Hospital — Stevenage, United Kingdom
FutureMeds Teesside - Middlefield Centre — Stockton-on-Tees, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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