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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
252

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percent Change from Baseline in Noncalcified Plaque (NCP) Volume
Time Frame: Baseline, Week 104
Baseline, Week 104

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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