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
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
3 other identifiers
interventional
252
7 countries
58
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2026
Typical duration for phase_3
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2026
CompletedFirst Posted
Study publicly available on registry
May 29, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
July 28, 2026
July 1, 2026
3.5 years
May 22, 2026
July 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change from Baseline in Noncalcified Plaque (NCP) Volume
Baseline, Week 104
Secondary Outcomes (4)
Percent Change from Baseline in Mean Fat Attenuation Index (FAI) Score
Baseline, Week 104
Percent Change from Baseline in Lp(a) Level
Baseline through Week 104
Percentage of Participants Reporting Strongly Agree or Agree on the Subcutaneous Administration Assessment Questionnaire (SQAAQ) Version 3.0 Items
Week 26, Week 78
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3819469
Predose through Week 52
Study Arms (2)
Lepodisiran
EXPERIMENTALParticipants will receive lepodisiran subcutaneously (SC)
Placebo
PLACEBO COMPARATORParticipants will receive placebo SC
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
UCSD - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, California, 92037-7410, United States
Valley Clinical Trials, Inc.
Northridge, California, 91325, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, 33312, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Merritt Island Medical Research, LLC
Merritt Island, Florida, 32952, United States
Inpatient Research Clinic
Miami Lakes, Florida, 33014, United States
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, 32789, United States
CARE Institute - High Desert
Meridian, Idaho, 83642, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Profound Research LLC
Farmington Hills, Michigan, 48334, United States
Vector Clinical Trials
Las Vegas, Nevada, 89128, United States
Heart and Vascular Research at WellSpan Health
York, Pennsylvania, 17403, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
Virginia Heart - Leesburg
Leesburg, Virginia, 20176, United States
Carilion Clinic
Roanoke, Virginia, 24014, United States
Eastside Research Associates
Redmond, Washington, 98052, United States
Nightingale Research
Adelaide, 5000, Australia
University of the Sunshine Coast (UniSC) Clinical Trials - Birtinya
Birtinya, 4575, Australia
Core Research Group
Brisbane, 4064, Australia
Advara HeartCare - Burwood
Burwood, 2134, Australia
Advara HeartCare Joondalup
Joondalup, 6027, Australia
Advara HeartCare Leabrook
Leabrook, 5068, Australia
AIM Research
Merewether, 2291, Australia
Advara HeartCare - Mulgrave
Mulgrave, 3170, Australia
USC Clinical Trials Brisbane (South Bank)
South Brisbane, 4101, Australia
Clinitrials
West Perth, 6005, Australia
Fakultni Nemocnice u sv. Anny v Brne
Brno, 60200, Czechia
EFERTUS healthcare s.r.o.
Brno, 615 00, Czechia
Top Moravia Health
Brno, 61500, Czechia
Fakultni Nemocnice u sv. Anny v Brne
Brno, 656 91, Czechia
Óbudai Egészségügyi Centrum
Budapest, 1036, Hungary
Semmelweis University
Budapest, 1122, Hungary
Szabolcs Szatmár Bereg Vármegyei Oktatókórház
Nyíregyháza, 4400, Hungary
Medisch Spectrum Twente
Enschede, 7512 KZ, Netherlands
Ziekenhuis St. Jansdal
Harderwijk, 3844 DG, Netherlands
Alrijne Ziekenhuis, locatie Leiderdorp
Leiderdorp, 2353 GA, Netherlands
VieCuri Medisch Centrum, locatie Venlo
Venlo, 5912 BL, Netherlands
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, 15001, Spain
Parc de Salut Mar - Hospital del Mar
Barcelona, 08003, Spain
Hospital Quiron Barcelona
Barcelona, 08023, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Insular de Gran Canaria
Las Palmas de Gran Canaria, 35016, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital General Universitario de Valencia
Valencia, 46014, Spain
FutureMeds - Birmingham
Birmingham, B21 9RY, United Kingdom
Bristol Royal Infirmary
Bristol, BS2 8HW, United Kingdom
Cheadle Community Hospital
Cheadle, ST10 1NS, United Kingdom
Royal Lancaster Infirmary
Lancaster, LA1 4RP, United Kingdom
Lincoln County Hospital
Lincoln, LN2 5QY, United Kingdom
Futuremeds-Newcastle
Newcastle, NE6 1SG, United Kingdom
The John Radcliffe Hospital
Oxford, OX3 9DU, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S5 7AU, United Kingdom
Lister Hospital
Stevenage, SG1 4AB, United Kingdom
FutureMeds Teesside - Middlefield Centre
Stockton-on-Tees, TS19 8PE, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2026
First Posted
May 29, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
December 1, 2029
Last Updated
July 28, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.