A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Lepodisiran to Investigate the Effect on Coronary Plaque in Adults With Elevated Lp(a) Who Have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event
Status: Recruiting
Location: See all (54) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
California
UCSD - Altman Clinical and Translational Research Institute (ACTRI)
NOT_YET_RECRUITING
La Jolla
Valley Clinical Trials, Inc.
RECRUITING
Northridge
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
RECRUITING
Torrance
Florida
Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
RECRUITING
Fort Lauderdale
Jacksonville Center for Clinical Research
RECRUITING
Jacksonville
Merritt Island Medical Research, LLC
RECRUITING
Merritt Island
Inpatient Research Clinic
RECRUITING
Miami Lakes
Clinical Site Partners, LLC dba Flourish Research
RECRUITING
Winter Park
Idaho
CARE Institute - High Desert
NOT_YET_RECRUITING
Meridian
Massachusetts
Massachusetts General Hospital
NOT_YET_RECRUITING
Boston
Michigan
Profound Research LLC
RECRUITING
Farmington Hills
Nevada
Vector Clinical Trials
RECRUITING
Las Vegas
Pennsylvania
Heart and Vascular Research at WellSpan Health
RECRUITING
York
Utah
Intermountain Medical Center
NOT_YET_RECRUITING
Murray
Virginia
Virginia Heart
NOT_YET_RECRUITING
Falls Church
Carilion Clinic
RECRUITING
Roanoke
Washington
Eastside Research Associates
RECRUITING
Redmond
Other Locations
Australia
Nightingale Research
RECRUITING
Adelaide
University of the Sunshine Coast (UniSC) Clinical Trials - Birtinya
RECRUITING
Birtinya
Core Research Group
NOT_YET_RECRUITING
Brisbane
Advara HeartCare - Burwood
RECRUITING
Burwood
Advara HeartCare Joondalup
RECRUITING
Joondalup
Advara HeartCare Leabrook
RECRUITING
Leabrook
AIM Research
RECRUITING
Merewether
Advara HeartCare - Mulgrave
NOT_YET_RECRUITING
Mulgrave
USC Clinical Trials Brisbane (South Bank)
RECRUITING
South Brisbane
Clinitrials
RECRUITING
West Perth
Hungary
Óbudai Egészségügyi Centrum
RECRUITING
Budapest
Semmelweis University
NOT_YET_RECRUITING
Budapest
Szabolcs Szatmár Bereg Vármegyei Oktatókórház
NOT_YET_RECRUITING
Nyíregyháza
Netherlands
Medisch Spectrum Twente
NOT_YET_RECRUITING
Enschede
Ziekenhuis St. Jansdal
NOT_YET_RECRUITING
Harderwijk
Alrijne Ziekenhuis, locatie Leiderdorp
NOT_YET_RECRUITING
Leiderdorp
VieCuri Medisch Centrum, locatie Venlo
NOT_YET_RECRUITING
Venlo
Spain
CHUAC-Complejo Hospitalario Universitario A Coruña
RECRUITING
A Coruña
Hospital Quiron Barcelona
RECRUITING
Barcelona
Parc de Salut Mar - Hospital del Mar
RECRUITING
Barcelona
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
Hospital Insular de Gran Canaria
RECRUITING
Las Palmas De Gran Canaria
Hospital Clinico San Carlos
NOT_YET_RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Hospital Universitario Virgen Del Rocio
NOT_YET_RECRUITING
Seville
Hospital Universitario Virgen Macarena
NOT_YET_RECRUITING
Seville
Hospital General Universitario de Valencia
NOT_YET_RECRUITING
Valencia
United Kingdom
FutureMeds - Birmingham
RECRUITING
Birmingham
Bristol Royal Infirmary
NOT_YET_RECRUITING
Bristol
Cheadle Community Hospital
NOT_YET_RECRUITING
Cheadle
Royal Lancaster Infirmary
NOT_YET_RECRUITING
Lancaster
Lincoln County Hospital
NOT_YET_RECRUITING
Lincoln
Futuremeds-Newcastle
RECRUITING
Newcastle
The John Radcliffe Hospital
NOT_YET_RECRUITING
Oxford
Sheffield Teaching Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Sheffield
Lister Hospital
RECRUITING
Stevenage
FutureMeds Teesside - Middlefield Centre
RECRUITING
Stockton-on-tees
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2029-12
Participants
Target number of participants: 252
Treatments
Experimental: Lepodisiran
Participants will receive lepodisiran subcutaneously (SC)
Placebo_comparator: Placebo
Participants will receive placebo SC
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company