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 (ACCLAIM-CTA)

May 22, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

252

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 317-615-4559
  • Email: LillyTrials@Lilly.com

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Nightingale Research
        • Principal Investigator:
          • Andrew Hamilton
      • Birtinya, Australia, 4575
        • University of the Sunshine Coast (UniSC) Clinical Trials - Birtinya
        • Principal Investigator:
          • Peter De Wet
      • Brisbane, Australia, 4064
        • Core Research Group
        • Contact:
          • Phone Number: 61738765688
        • Principal Investigator:
          • David Colquhoun
      • Burwood, Australia, 2134
        • Advara HeartCare - Burwood
        • Principal Investigator:
          • Vincent Khoury
      • Joondalup, Australia, 6027
        • Advara HeartCare Joondalup
        • Principal Investigator:
          • Peter Purnell
        • Contact:
          • Phone Number: 61894006111
      • Leabrook, Australia, 5068
        • Advara HeartCare Leabrook
        • Principal Investigator:
          • Jamie Morton
      • Merewether, Australia, 2291
        • Aim Research
        • Principal Investigator:
          • Claire Morbey
        • Contact:
          • Phone Number: +61 2 4963 2323
      • Mulgrave, Australia, 3170
        • Advara HeartCare - Mulgrave
        • Contact:
          • Phone Number: (03) 8793 3800
        • Principal Investigator:
          • Piyush Srivastava
      • South Brisbane, Australia, 4101
        • USC Clinical Trials Brisbane (South Bank)
        • Principal Investigator:
          • Carla Evangelista
      • West Perth, Australia, 6005
        • Clinitrials
        • Principal Investigator:
          • Chris Judkins
  • Czechia
      • Brno, Czechia, 656 91
        • Fakultni nemocnice u sv. Anny v Brne
        • Principal Investigator:
          • Robert Prosecky
      • Brno, Czechia, 60200
        • Fakultni nemocnice u sv. Anny v Brne
        • Principal Investigator:
          • Vladimir Kincl
      • Brno, Czechia, 615 00
        • EFERTUS healthcare s.r.o.
        • Principal Investigator:
          • Hana Matejovska
        • Contact:
          • Phone Number: 420 606 417 244
      • Brno, Czechia, 61500
        • Top Moravia Health
        • Principal Investigator:
          • Veronika Fendrychova
        • Contact:
          • Phone Number: 00420 734 395 787
  • Hungary
      • Budapest, Hungary, 1122
        • Semmelweis University
        • Contact:
          • Phone Number: 3614586840
        • Principal Investigator:
          • Béla Merkely
      • Budapest, Hungary, 1036
        • Óbudai Egészségügyi Centrum
        • Principal Investigator:
          • Viktor Vass
        • Contact:
          • Phone Number: 36 70 450 8040
      • Nyíregyháza, Hungary, 4400
        • Szabolcs Szatmár Bereg Vármegyei Oktatókórház
        • Principal Investigator:
          • Zsolt Zilahi
        • Contact:
          • Phone Number: 0036209530430
  • Netherlands
      • Enschede, Netherlands, 7512 KZ
        • Medisch Spectrum Twente
        • Principal Investigator:
          • Paolo Zocca
      • Harderwijk, Netherlands, 3844 DG
        • Ziekenhuis St. Jansdal
        • Principal Investigator:
          • Marc van der Zee
        • Contact:
          • Phone Number: 0341463745
      • Leiderdorp, Netherlands, 2353 GA
        • Alrijne Ziekenhuis, locatie Leiderdorp
        • Contact:
          • Phone Number: 0715828485
        • Principal Investigator:
          • Tjeerd Römer
      • Venlo, Netherlands, 5912 BL
        • VieCuri Medisch Centrum, locatie Venlo
        • Principal Investigator:
          • Wouter Remkes
        • Contact:
          • Phone Number: 0773205603
  • Spain
      • A Coruña, Spain, 15001
        • CHUAC-Complejo Hospitalario Universitario A Coruña
        • Principal Investigator:
          • Jose Luis Diaz Diaz
        • Contact:
          • Phone Number: 34 628 544 729
      • Barcelona, Spain, 08023
        • Hospital Quiron Barcelona
        • Principal Investigator:
          • Fernando Cereto Castro
        • Contact:
          • Phone Number: 932850000
      • Barcelona, Spain, 08003
        • Parc de Salut Mar - Hospital del Mar
        • Contact:
          • Phone Number: 93 248 30 39
        • Principal Investigator:
          • Diego Pérez Zerpa
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofía
        • Contact:
          • Phone Number: 34957010947
        • Principal Investigator:
          • Jose Lopez Miranda
      • Las Palmas de Gran Canaria, Spain, 35016
        • Hospital Insular de Gran Canaria
        • Principal Investigator:
          • Rosa María Sánchez Hernández
        • Contact:
          • Phone Number: 663873243
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
        • Principal Investigator:
          • Olivia Sanchez Sanchez
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
        • Principal Investigator:
          • Manuel Mendez
        • Contact:
          • Phone Number: 0034 913 30 30 00
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio
        • Principal Investigator:
          • Luis Beltrán
        • Contact:
          • Phone Number: 0034 955 01 20 00
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena
        • Principal Investigator:
          • Rafael Jesús Hidalgo Urbano
        • Contact:
          • Phone Number: 34955034939
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
        • Principal Investigator:
          • Francesc Puchades
  • United Kingdom
      • Birmingham, United Kingdom, B21 9RY
        • FutureMeds - Birmingham
        • Principal Investigator:
          • Tehmina Ahmed
        • Contact:
          • Phone Number: 0121 592 2050
      • Bristol, United Kingdom, BS2 8HW
        • Bristol Royal Infirmary
        • Principal Investigator:
          • Kofi Antwi
      • Cheadle, United Kingdom, ST10 1NS
        • Cheadle Community Hospital
        • Principal Investigator:
          • Mark Stone
        • Contact:
          • Phone Number: 07452948414
      • Lancaster, United Kingdom, LA1 4RP
        • Royal Lancaster Infirmary
        • Principal Investigator:
          • Mohamed Elnaggar
      • Lincoln, United Kingdom, LN2 5QY
        • Lincoln County Hospital
        • Principal Investigator:
          • Vinod Venugopal
      • Newcastle, United Kingdom, NE6 1SG
        • Futuremeds-Newcastle
        • Principal Investigator:
          • William Aspinall
      • Oxford, United Kingdom, OX3 9DU
        • The John Radcliffe Hospital
        • Principal Investigator:
          • Rafail Kotronias
      • Sheffield, United Kingdom, S5 7AU
        • Sheffield Teaching Hospitals NHS Foundation Trust
        • Contact:
          • Phone Number: +44 114 2266159
        • Principal Investigator:
          • Robert Storey
      • Stevenage, United Kingdom, SG1 4AB
        • Lister Hospital
        • Principal Investigator:
          • Mary Lynch
        • Contact:
          • Phone Number: 01438 314333
      • Stockton-on-Tees, United Kingdom, TS19 8PE
        • FutureMeds Teesside - Middlefield Centre
        • Contact:
          • Phone Number: 01642843780
        • Principal Investigator:
          • Anneliese Flatt
  • United States
    • California
      • La Jolla, California, United States, 92037-7410
        • UCSD - Altman Clinical and Translational Research Institute (ACTRI)
        • Principal Investigator:
          • Michael Wilkinson
        • Contact:
          • Phone Number: 858-246-2510
      • Northridge, California, United States, 91325
        • Valley Clinical Trials, Inc.
        • Contact:
          • Phone Number: 818-678-4900
        • Principal Investigator:
          • Mehrdad Ariani
      • Torrance, California, United States, 90502
        • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
        • Principal Investigator:
          • Ignacio Velazquez
        • Contact:
          • Phone Number: 424-201-3000
    • Florida
      • Fort Lauderdale, Florida, United States, 33312
        • Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
        • Principal Investigator:
          • Sam Lerman
        • Contact:
          • Phone Number: 954-963-7100
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
        • Contact:
          • Phone Number: 904-730-0101
        • Principal Investigator:
          • Erich Schramm
      • Merritt Island, Florida, United States, 32952
        • Merritt Island Medical Research, LLC
        • Principal Investigator:
          • David Kirk
      • Miami Lakes, Florida, United States, 33014
        • Inpatient Research Clinic
        • Principal Investigator:
          • Alexis Gutierrez
        • Contact:
          • Phone Number: 786-502-4303
      • Winter Park, Florida, United States, 32789
        • Clinical Site Partners, LLC DBA Flourish Research
        • Contact:
          • Phone Number: 407-740-8078
        • Principal Investigator:
          • Monica Aggarwal
    • Idaho
      • Meridian, Idaho, United States, 83642
        • CARE Institute - High Desert
        • Principal Investigator:
          • David Hinchman
        • Contact:
          • Phone Number: 208-398-4306
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
        • Principal Investigator:
          • Michael Honigberg
        • Contact:
          • Phone Number: 617-726-1843
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Profound Research LLC
        • Contact:
          • Phone Number: 947-254-1920
        • Principal Investigator:
          • Herman-Simon Kado
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Vector Clinical Trials
        • Principal Investigator:
          • Bharat Mocherla
        • Contact:
          • Phone Number: 702-750-000
    • Pennsylvania
      • York, Pennsylvania, United States, 17403
        • Heart and Vascular Research at WellSpan Health
        • Contact:
          • Phone Number: 717-851-2441
        • Principal Investigator:
          • Rhian Davies
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
        • Contact:
          • Phone Number: 801-507-4707
        • Principal Investigator:
          • Jeffrey Anderson
    • Virginia
      • Leesburg, Virginia, United States, 20176
        • Virginia Heart - Leesburg
        • Principal Investigator:
          • Karan Desai
      • Roanoke, Virginia, United States, 24014
        • Carilion Clinic
        • Principal Investigator:
          • Lana Wahid
    • Washington
      • Redmond, Washington, United States, 98052
        • Eastside Research Associates
        • Contact:
          • Phone Number: 425-869-6828
        • Principal Investigator:
          • Christopher Price

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo SC
Drug: Placebo
Administered SC
Experimental: Lepodisiran
Participants will receive lepodisiran subcutaneously (SC)
Drug: Lepodisiran
Administered SC
Other Names:
  • LY3819469

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in Noncalcified Plaque (NCP) Volume
Time Frame: Baseline, Week 104
Baseline, Week 104

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in Mean Fat Attenuation Index (FAI) Score
Time Frame: Baseline, Week 104
Baseline, Week 104
Percent Change from Baseline in Lp(a) Level
Time Frame: Baseline through Week 104
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
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
Predose through Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

May 22, 2026

First Submitted That Met QC Criteria

May 22, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27554
  • J3L-MC-EZEJ (Other Identifier: Eli Lilly and Company)
  • 2025-524858-34-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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