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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Lepodisiran
  Administered SC
• Препарат Placebo
  Administered SC

Первичные конечные точки

• Percent Change from Baseline in Noncalcified Plaque (NCP) Volume [Срок оценки: Baseline, Week 104]

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 17 центров

• 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
• … и ещё 9 центров

Австралия · 10 центров

• 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
• … и ещё 2 центра

Испания · 10 центров

• 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
• … и ещё 2 центра

Великобритания · 10 центров

• 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
• … и ещё 2 центра

Чехия · 4 центра

• 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

Нидерланды · 4 центра

• Medisch Spectrum Twente — Enschede
• Ziekenhuis St. Jansdal — Harderwijk
• Alrijne Ziekenhuis, locatie Leiderdorp — Leiderdorp
• VieCuri Medisch Centrum, locatie Venlo — Venlo

Венгрия · 3 центра

• Óbudai Egészségügyi Centrum — Budapest
• Semmelweis University — Budapest
• Szabolcs Szatmár Bereg Vármegyei Oktatókórház — Nyíregyháza

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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