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NCT07613294PHASE3Recruiting

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

Eli Lilly and Company

Start Date

6/1/2026

Completion Date

12/1/2029

Summary

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.

Eligibility Criteria

Age Range: 45 years to 80 years

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

Interventions

DRUG

Lepodisiran

DRUG

Placebo

Interested in This Trial?

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Conditions

AtherosclerosisCardiovascular DiseasesLipoprotein(a)

Locations

UCSD - Altman Clinical and Translational Research Institute (ACTRI)

La Jolla, California 92037-7410

United States

Valley Clinical Trials, Inc.

Northridge, California 91325

United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California 90502

United States

Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care

Fort Lauderdale, Florida 33312

United States

Jacksonville Center for Clinical Research

Jacksonville, Florida 32216

United States

Merritt Island Medical Research, LLC

Merritt Island, Florida 32952

United States

Inpatient Research Clinic

Miami Lakes, Florida 33014

United States

Clinical Site Partners, LLC dba Flourish Research

Winter Park, Florida 32789

United States

CARE Institute - High Desert

Meridian, Idaho 83642

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Profound Research LLC

Farmington Hills, Michigan 48334

United States

Vector Clinical Trials

Las Vegas, Nevada 89128

United States

Heart and Vascular Research at WellSpan Health

York, Pennsylvania 17403

United States

Intermountain Medical Center

Murray, Utah 84107

United States

Virginia Heart - Leesburg

Leesburg, Virginia 20176

United States

Carilion Clinic

Roanoke, Virginia 24014

United States

Eastside Research Associates

Redmond, Washington 98052

United States

Nightingale Research

Adelaide, 5000

Australia

University of the Sunshine Coast (UniSC) Clinical Trials - Birtinya

Birtinya, 4575

Australia

Core Research Group

Brisbane, 4064

Australia

Advara HeartCare - Burwood

Burwood, 2134

Australia

Advara HeartCare Joondalup

Joondalup, 6027

Australia

Advara HeartCare Leabrook

Leabrook, 5068

Australia

AIM Research

Merewether, 2291

Australia

Advara HeartCare - Mulgrave

Mulgrave, 3170

Australia

USC Clinical Trials Brisbane (South Bank)

South Brisbane, 4101

Australia

Clinitrials

West Perth, 6005

Australia

Fakultni Nemocnice u sv. Anny v Brne

Brno, 60200

Czechia

EFERTUS healthcare s.r.o.

Brno, 615 00

Czechia

Top Moravia Health

Brno, 61500

Czechia

Fakultni Nemocnice u sv. Anny v Brne

Brno, 656 91

Czechia

Óbudai Egészségügyi Centrum

Budapest, 1036

Hungary

Semmelweis University

Budapest, 1122

Hungary

Szabolcs Szatmár Bereg Vármegyei Oktatókórház

Nyíregyháza, 4400

Hungary

Medisch Spectrum Twente

Enschede, 7512 KZ

Netherlands

Ziekenhuis St. Jansdal

Harderwijk, 3844 DG

Netherlands

Alrijne Ziekenhuis, locatie Leiderdorp

Leiderdorp, 2353 GA

Netherlands

VieCuri Medisch Centrum, locatie Venlo

Venlo, 5912 BL

Netherlands

CHUAC-Complejo Hospitalario Universitario A Coruña

A Coruña, 15001

Spain

Parc de Salut Mar - Hospital del Mar

Barcelona, 08003

Spain

Hospital Quiron Barcelona

Barcelona, 08023

Spain

Hospital Universitario Reina Sofia

Córdoba, 14004

Spain

Hospital Insular de Gran Canaria

Las Palmas de Gran Canaria, 35016

Spain

Hospital Universitario Ramón y Cajal

Madrid, 28034

Spain

Hospital Clinico San Carlos

Madrid, 28040

Spain

Hospital Universitario Virgen Macarena

Seville, 41009

Spain

Hospital Universitario Virgen Del Rocio

Seville, 41013

Spain

Hospital General Universitario de Valencia

Valencia, 46014

Spain

FutureMeds - Birmingham

Birmingham, B21 9RY

United Kingdom

Bristol Royal Infirmary

Bristol, BS2 8HW

United Kingdom

Cheadle Community Hospital

Cheadle, ST10 1NS

United Kingdom

Royal Lancaster Infirmary

Lancaster, LA1 4RP

United Kingdom

Lincoln County Hospital

Lincoln, LN2 5QY

United Kingdom

Futuremeds-Newcastle

Newcastle, NE6 1SG

United Kingdom

The John Radcliffe Hospital

Oxford, OX3 9DU

United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S5 7AU

United Kingdom

Lister Hospital

Stevenage, SG1 4AB

United Kingdom

FutureMeds Teesside - Middlefield Centre

Stockton-on-Tees, TS19 8PE

United Kingdom