AtherosclerosisPhase 3ACCLAIM-CTANCT07613294
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
A Phase 3 study testing Lepodisiran in people with Atherosclerosis and Cardiovascular Diseases, run by Eli Lilly and Company at 57 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Atherosclerosis, Cardiovascular Diseases, Lipoprotein(a)
- What is being tested?
- Lepodisiran
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 57 sitesin 7 countries
- Study dates
- 1 Jun 2026to Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
57 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
57 sites in 7 countries
United States17 sites, 17 recruiting
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
617-726-1843
Michael Honigberg
- Recruiting
Virginia Heart
Falls Church, Virginia, 22042
703-766-5920
Tariq Haddad
- Recruiting
Profound Research LLC
Farmington Hills, Michigan, 48334
947-254-1920
Herman-Simon Kado
- Recruiting
Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, 33312
954-963-7100
Sam Lerman
- Recruiting
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
904-730-0101
Erich Schramm
- Recruiting
UCSD - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, California, 92037-7410
858-246-2510
Michael Wilkinson
- Recruiting
Vector Clinical Trials
Las Vegas, Nevada, 89128
702-750-000
Bharat Mocherla
- Recruiting
High Desert Heart & Vascular
Meridian, Idaho, 83642
208-398-4306
David Hinchman
- Recruiting
Merritt Island Medical Research, LLC
Merritt Island, Florida, 32952
David Kirk
- Recruiting
Inpatient Research Clinic
Miami Lakes, Florida, 33014
786-502-4303
Alexis Gutierrez
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107
801-507-4707
Jeffrey Anderson
- Recruiting
Valley Clinical Trials, Inc.
Northridge, California, 91325
818-678-4900
Mehrdad Ariani
- Recruiting
Eastside Research Associates
Redmond, Washington, 98052
425-869-6828
Christopher Price
- Recruiting
Carilion Clinic
Roanoke, Virginia, 24014
Lana Wahid
- Recruiting
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
424-201-3000
Ignacio Velazquez
- Recruiting
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, 32789
407-740-8078
Monica Aggarwal
- Recruiting
Heart and Vascular Research at WellSpan Health
York, Pennsylvania, 17403
717-851-2441
Rhian Davies
Spain10 sites, 10 recruiting
- Recruiting
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, 15001
34 628 544 729
Jose Luis Diaz Diaz
- Recruiting
Parc de Salut Mar - Hospital del Mar
Barcelona, 08003
93 248 30 39
Diego Pérez Zerpa
- Recruiting
Hospital Quiron Barcelona
Barcelona, 08023
932850000
Fernando Cereto Castro
- Recruiting
Hospital Universitario Reina Sofia
Córdoba, 14004
34957010947
Jose Lopez Miranda
- Recruiting
Hospital Insular de Gran Canaria
Las Palmas de Gran Canaria, 35016
663873243
Rosa María Sánchez Hernández
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
Olivia Sanchez Sanchez
- Recruiting
Hospital Clinico San Carlos
Madrid, 28040
0034 913 30 30 00
Manuel Mendez
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
34955034939
Rafael Jesús Hidalgo Urbano
- Recruiting
Hospital Universitario Virgen Del Rocio
Seville, 41013
0034 955 01 20 00
Luis Beltrán
- Recruiting
Hospital General Universitario de Valencia
Valencia, 46014
Francesc Puchades
United Kingdom10 sites, 10 recruiting
- Recruiting
FutureMeds - Birmingham
Birmingham, B21 9RY
0121 592 2050
Tehmina Ahmed
- Recruiting
Bristol Royal Infirmary
Bristol, BS2 8HW
Kofi Antwi
- Recruiting
Cheadle Community Hospital
Cheadle, ST10 1NS
07452948414
Mark Stone
- Recruiting
Royal Lancaster Infirmary
Lancaster, LA1 4RP
Mohamed Elnaggar
- Recruiting
Lincoln County Hospital
Lincoln, LN2 5QY
Vinod Venugopal
- Recruiting
Futuremeds-Newcastle
Newcastle, NE6 1SG
William Aspinall
- Recruiting
The John Radcliffe Hospital
Oxford, OX3 9DU
Rafail Kotronias
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S5 7AU
+44 114 2266159
Robert Storey
- Recruiting
Lister Hospital
Stevenage, SG1 4AB
01438 314333
Mary Lynch
- Recruiting
FutureMeds Teesside - Middlefield Centre
Stockton-on-Tees, TS19 8PE
01918205151
Anneliese Flatt
Australia9 sites, 9 recruiting
- Recruiting
Nightingale Research
Adelaide, 5000
Andrew Hamilton
- Recruiting
University of the Sunshine Coast (UniSC) Clinical Trials - Birtinya
Birtinya, 4575
Peter De Wet
- Recruiting
Core Research Group
Brisbane, 4064
61738765688
David Colquhoun
- Recruiting
Advara HeartCare - Burwood
Burwood, 2134
Vincent Khoury
- Recruiting
Advara HeartCare Joondalup
Joondalup, 6027
61894006111
Peter Purnell
- Recruiting
Advara HeartCare Leabrook
Leabrook, 5068
Jamie Morton
- Recruiting
AIM Research
Merewether, 2291
+61 2 4963 2323
Claire Morbey
- Recruiting
USC Clinical Trials Brisbane (South Bank)
South Brisbane, 4101
Carla Evangelista
- Recruiting
Clinitrials
West Perth, 6005
Chris Judkins
Czechia4 sites, 4 recruiting
- Recruiting
Fakultni Nemocnice u sv. Anny v Brne
Brno, 60200
Vladimir Kincl
- Recruiting
EFERTUS healthcare s.r.o.
Brno, 615 00
420 606 417 244
Hana Matejovska
- Recruiting
Top Moravia Health
Brno, 61500
00420 734 395 787
Veronika Fendrychova
- Recruiting
Fakultni Nemocnice u sv. Anny v Brne
Brno, 656 91
Robert Prosecky
Netherlands4 sites, 4 recruiting
- Recruiting
Medisch Spectrum Twente
Enschede, 7512 KZ
Paolo Zocca
- Not yet recruiting
Ziekenhuis St. Jansdal
Harderwijk, 3844 DG
0341463745
Marc van der Zee
- Not yet recruiting
Alrijne Ziekenhuis, locatie Leiderdorp
Leiderdorp, 2353 GA
0715828485
Tjeerd Römer
- Not yet recruiting
VieCuri Medisch Centrum, locatie Venlo
Venlo, 5912 BL
0773205603
Wouter Remkes
Hungary3 sites, 3 recruiting
- Recruiting
Óbudai Egészségügyi Centrum
Budapest, 1036
36 70 450 8040
Viktor Vass
- Recruiting
Semmelweis University
Budapest, 1122
3614586840
Béla Merkely
- Recruiting
Szabolcs Szatmár Bereg Vármegyei Oktatókórház
Nyíregyháza, 4400
0036209530430
Zsolt Zilahi
About this study
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
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.
- Conditions
- Atherosclerosis, Cardiovascular Diseases, Lipoprotein(a)
- Being tested
- Lepodisiran, Placebo
- Keywords
- CCTA, Coronary plaque burden
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LepodisiranDrug
Also called LY3819469
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Lepodisiran | Experimental | Participants will receive lepodisiran subcutaneously (SC) Receives: Drug: Lepodisiran |
| Placebo | Placebo comparator | Participants will receive placebo SC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline in Noncalcified Plaque (NCP) Volume
Measured: Baseline, Week 104
Secondary outcomes (4)
Percent Change from Baseline in Mean Fat Attenuation Index (FAI) Score
Measured: Baseline, Week 104
Percent Change from Baseline in Lp(a) Level
Measured: Baseline through Week 104
Percentage of Participants Reporting Strongly Agree or Agree on the Subcutaneous Administration Assessment Questionnaire (SQAAQ) Version 3.0 Items
Measured: Week 26, Week 78
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3819469
Measured: Predose through Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Jun 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613294
- Sponsor's protocol ID
- 27554
- Other IDs
- J3L-MC-EZEJ, 2025-524858-34-00, 2025
- Acronym
- ACCLAIM-CTA
- Status last verified
- Nov 2026
- First submitted
- 22 May 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07613294
- Acronym / sponsor ID
- ACCLAIM-CTA / 27554
- Conditions
- Atherosclerosis, Cardiovascular Diseases, Lipoprotein(a)
- Keywords
- CCTA, Coronary plaque burden
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lepodisiran | Experimental | Drug: LepodisiranParticipants will receive lepodisiran subcutaneously (SC) |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo SC |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LepodisiranAlso: LY3819469Administered SC | Drug | Lepodisiran |
| PlaceboAdministered SC | Drug | Placebo |
Primary outcome
Percent Change from Baseline in Noncalcified Plaque (NCP) Volume
Time frame: Baseline, Week 104
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- An imaging clinical trial testing the effect of lepodisiran vs placebo in adults with high Lp(a) who have or are at risk of heart disease, stroke, or peripheral artery disease. (ACCLAIM-CTA)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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) study director
Eli Lilly and Company
57 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lepodisiran in people with Atherosclerosis and Cardiovascular Diseases, run by Eli Lilly and Company at 57 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Spain, United Kingdom, Australia, Czechia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change from Baseline in Noncalcified Plaque (NCP) Volume (time frame: Baseline, Week 104). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.