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

Part of paid clinical trials in La Jolla, California.

Sponsor
Eli Lilly and Company
Study ID
NCT07613294
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Atherosclerosis
  • Cardiovascular Diseases
  • Lipoprotein(a)

Eligibility Criteria

Sex
ALL
Age
45 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Lepodisiran — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
May 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
252 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lepodisiran
    Participants will receive lepodisiran subcutaneously (SC)
  • Placebo Comparator: Placebo
    Participants will receive placebo SC

Primary Outcome Measure

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

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (17)

FacilityCityStateZIPSite coordinators
UCSD - Altman Clinical and Translational Research Institute (ACTRI)La JollaCalifornia92037-7410
858-246-2510
Michael Wilkinson (PRINCIPAL_INVESTIGATOR)
Valley Clinical Trials, Inc.NorthridgeCalifornia91325
818-678-4900
Mehrdad Ariani (PRINCIPAL_INVESTIGATOR)
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorranceCalifornia90502
424-201-3000
Ignacio Velazquez (PRINCIPAL_INVESTIGATOR)
Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine CareFort LauderdaleFlorida33312
954-963-7100
Sam Lerman (PRINCIPAL_INVESTIGATOR)
Jacksonville Center for Clinical ResearchJacksonvilleFlorida32216
904-730-0101
Erich Schramm (PRINCIPAL_INVESTIGATOR)
Merritt Island Medical Research, LLCMerritt IslandFlorida32952
David Kirk (PRINCIPAL_INVESTIGATOR)
Inpatient Research ClinicMiami LakesFlorida33014
786-502-4303
Alexis Gutierrez (PRINCIPAL_INVESTIGATOR)
Clinical Site Partners, LLC dba Flourish ResearchWinter ParkFlorida32789
407-740-8078
Monica Aggarwal (PRINCIPAL_INVESTIGATOR)
CARE Institute - High DesertMeridianIdaho83642
208-398-4306
David Hinchman (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
617-726-1843
Michael Honigberg (PRINCIPAL_INVESTIGATOR)
Profound Research LLCFarmington HillsMichigan48334
947-254-1920
Herman-Simon Kado (PRINCIPAL_INVESTIGATOR)
Vector Clinical TrialsLas VegasNevada89128
702-750-000
Bharat Mocherla (PRINCIPAL_INVESTIGATOR)
Heart and Vascular Research at WellSpan HealthYorkPennsylvania17403
717-851-2441
Rhian Davies (PRINCIPAL_INVESTIGATOR)
Intermountain Medical CenterMurrayUtah84107
801-507-4707
Jeffrey Anderson (PRINCIPAL_INVESTIGATOR)
Virginia Heart - LeesburgLeesburgVirginia20176
Karan Desai (PRINCIPAL_INVESTIGATOR)
Carilion ClinicRoanokeVirginia24014
Lana Wahid (PRINCIPAL_INVESTIGATOR)
Eastside Research AssociatesRedmondWashington98052
425-869-6828
Christopher Price (PRINCIPAL_INVESTIGATOR)

Find similar trials in La Jolla, CA

By research site
UCSD - Altman Clinical and Translational Research Institute (ACTRI)· La Jolla, CAValley Clinical Trials, Inc.· Northridge, CALundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center· Torrance, CAJellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care· Fort Lauderdale, FLJacksonville Center for Clinical Research· Jacksonville, FLMerritt Island Medical Research, LLC· Merritt Island, FL

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