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Clinical Trials in the UK / NCT07613294
Recruiting Phase 3

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

NCT07613294 · tracked via the Priya Life Science UK tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2026-06-01
Last updated
2026-09-08

Condition(s) studied

AtherosclerosisCardiovascular DiseasesLipoprotein(a)

Investigational drug(s) / intervention(s)

LepodisiranPlacebo

Lepodisiran: Administered SC

Placebo: Administered SC

Study 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

Sex
ALL
Min age
45 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (58)

FacilityCityRegionStatus
UCSD - Altman Clinical and Translational Research Institute (ACTRI) La Jolla California Not Yet Recruiting
Valley Clinical Trials, Inc. Northridge California Recruiting
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California Recruiting
Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care Fort Lauderdale Florida Recruiting
Jacksonville Center for Clinical Research Jacksonville Florida Recruiting
Merritt Island Medical Research, LLC Merritt Island Florida Recruiting
Inpatient Research Clinic Miami Lakes Florida Recruiting
Clinical Site Partners, LLC dba Flourish Research Winter Park Florida Recruiting
CARE Institute - High Desert Meridian Idaho Not Yet Recruiting
Massachusetts General Hospital Boston Massachusetts Not Yet Recruiting
Profound Research LLC Farmington Hills Michigan Recruiting
Vector Clinical Trials Las Vegas Nevada Recruiting
Heart and Vascular Research at WellSpan Health York Pennsylvania Recruiting
Intermountain Medical Center Murray Utah Not Yet Recruiting
Virginia Heart Falls Church Virginia Not Yet Recruiting
Carilion Clinic Roanoke Virginia Recruiting
Eastside Research Associates Redmond Washington Recruiting
Nightingale Research Adelaide Australia Recruiting
University of the Sunshine Coast (UniSC) Clinical Trials - Birtinya Birtinya Australia Recruiting
Core Research Group Brisbane Australia Not Yet Recruiting
Advara HeartCare - Burwood Burwood Australia Recruiting
Advara HeartCare Joondalup Joondalup Australia Recruiting
Advara HeartCare Leabrook Leabrook Australia Recruiting
AIM Research Merewether Australia Recruiting
Advara HeartCare - Mulgrave Mulgrave Australia Not Yet Recruiting
USC Clinical Trials Brisbane (South Bank) South Brisbane Australia Recruiting
Clinitrials West Perth Australia Recruiting
Fakultni Nemocnice u sv. Anny v Brne Brno Czechia Recruiting
EFERTUS healthcare s.r.o. Brno Czechia Recruiting
Top Moravia Health Brno Czechia Recruiting
Fakultni Nemocnice u sv. Anny v Brne Brno Czechia Recruiting
Óbudai Egészségügyi Centrum Budapest Hungary Recruiting
Semmelweis University Budapest Hungary Not Yet Recruiting
Szabolcs Szatmár Bereg Vármegyei Oktatókórház Nyíregyháza Hungary Not Yet Recruiting
Medisch Spectrum Twente Enschede Netherlands Not Yet Recruiting
Ziekenhuis St. Jansdal Harderwijk Netherlands Not Yet Recruiting
Alrijne Ziekenhuis, locatie Leiderdorp Leiderdorp Netherlands Not Yet Recruiting
VieCuri Medisch Centrum, locatie Venlo Venlo Netherlands Not Yet Recruiting
CHUAC-Complejo Hospitalario Universitario A Coruña A Coruña Spain Recruiting
Parc de Salut Mar - Hospital del Mar Barcelona Spain Recruiting

+ 18 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07613294 on ClinicalTrials.gov ↗ ← All trials in the UK