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Recruiting 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

Phase III Interventional Atherosclerosis Cardiovascular Diseases Lipoprotein(a)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lepodisiran, Placebo.
Who it may be relevant to
Registry conditions: Atherosclerosis, Cardiovascular Diseases, Lipoprotein(a). Basic parameters: 45 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Czechia, Hungary, Netherlands +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug Lepodisiran
    Administered SC
  • Drug Placebo
    Administered SC

Primary outcome measures

  • Percent Change from Baseline in Noncalcified Plaque (NCP) Volume [Time frame: Baseline, Week 104]
Secondary outcome measures (4)
  • Percent Change from Baseline in Mean Fat Attenuation Index (FAI) Score [Time frame: Baseline, Week 104]
  • Percent Change from Baseline in Lp(a) Level [Time frame: Baseline through Week 104]
  • Percentage of Participants Reporting Strongly Agree or Agree on the Subcutaneous Administration Assessment Questionnaire (SQAAQ) Version 3.0 Items [Time frame: Week 26, Week 78]
  • Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3819469 [Time frame: Predose through Week 52]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 17 centers
  • UCSD - Altman Clinical and Translational Research Institute (ACTRI) — La Jolla
  • Valley Clinical Trials, Inc. — Northridge
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance
  • Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care — Fort Lauderdale
  • Jacksonville Center for Clinical Research — Jacksonville
  • Merritt Island Medical Research, LLC — Merritt Island
  • Inpatient Research Clinic — Miami Lakes
  • Clinical Site Partners, LLC dba Flourish Research — Winter Park
  • … and 9 more centers
Australia · 10 centers
  • Nightingale Research — Adelaide
  • University of the Sunshine Coast (UniSC) Clinical Trials - Birtinya — Birtinya
  • Core Research Group — Brisbane
  • Advara HeartCare - Burwood — Burwood
  • Advara HeartCare Joondalup — Joondalup
  • Advara HeartCare Leabrook — Leabrook
  • AIM Research — Merewether
  • Advara HeartCare - Mulgrave — Mulgrave
  • … and 2 more centers
Spain · 10 centers
  • CHUAC-Complejo Hospitalario Universitario A Coruña — A Coruña
  • Parc de Salut Mar - Hospital del Mar — Barcelona
  • Hospital Quiron Barcelona — Barcelona
  • Hospital Universitario Reina Sofia — Córdoba
  • Hospital Insular de Gran Canaria — Las Palmas de Gran Canaria
  • Hospital Universitario Ramón y Cajal — Madrid
  • Hospital Clinico San Carlos — Madrid
  • Hospital Universitario Virgen Macarena — Seville
  • … and 2 more centers
United Kingdom · 10 centers
  • FutureMeds - Birmingham — Birmingham
  • Bristol Royal Infirmary — Bristol
  • Cheadle Community Hospital — Cheadle
  • Royal Lancaster Infirmary — Lancaster
  • Lincoln County Hospital — Lincoln
  • Futuremeds-Newcastle — Newcastle
  • The John Radcliffe Hospital — Oxford
  • Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield
  • … and 2 more centers
Czechia · 4 centers
  • Fakultni Nemocnice u sv. Anny v Brne — Brno
  • EFERTUS healthcare s.r.o. — Brno
  • Top Moravia Health — Brno
  • Fakultni Nemocnice u sv. Anny v Brne — Brno
Netherlands · 4 centers
  • Medisch Spectrum Twente — Enschede
  • Ziekenhuis St. Jansdal — Harderwijk
  • Alrijne Ziekenhuis, locatie Leiderdorp — Leiderdorp
  • VieCuri Medisch Centrum, locatie Venlo — Venlo
Hungary · 3 centers
  • Óbudai Egészségügyi Centrum — Budapest
  • Semmelweis University — Budapest
  • Szabolcs Szatmár Bereg Vármegyei Oktatókórház — Nyíregyháza

Identifiers

NCT: NCT07613294 · 27554 · J3L-MC-EZEJ · 2025-524858-34-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗