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Lepodisiran

Phase 3

Atherosclerotic Cardiovascular Disease (ASCVD) | Small molecule | Other |Eli Lilly and Company|Last Updated: May 19, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment17,300
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06292013A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)PHASE3 ACTIVE NOT_RECRUITING 17,300 — — Mar 5, 2024Mar 1, 2029May 19, 2026933 United States, Argentina +26
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Study Endpoints
Primary Endpoints
Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint
Baseline up to End of Study (About 4.5 Years)

Time to first event in a MACE-4 composite endpoint, comprised of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent coronary revascularization.

Secondary Endpoints
Change from Baseline in Lipoprotein(a) [Lp(a)] at Week 4
Baseline, Week 4
Time to First Occurrence of Any of the Component of MACE-3 Composite Endpoint
Baseline up to End of Study (About 4.5 Years)
Time to First Occurrence of Fatal or Non-Fatal Myocardial Infarction
Baseline up to End of Study (About 4.5 Years)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Lepodisiran SodiumEXPERIMENTALLepodisiran sodium administered subcutaneously (SC).
PlaceboPLACEBO_COMPARATORPlacebo administered SC.
Interventions
NameTypeDescription
Lepodisiran SodiumDRUGAdministered SC
PlaceboDRUGAdministered SC
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites933

Inclusion Criteria: * Have Lipoprotein(a) \[Lp(a)\] ≥175 nanomoles per liter (nmol/L). * Meet criteria of either 2a or 2b: 2a: Individuals 18 years of age or older with established atherosclerotic cardiovascular disease (ASCVD) with an event or revascularization. 2b: Individuals 55 years of a...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilCanadaChinaCzechiaDenmarkFranceGermanyGreeceHungaryIndiaIsraelItalyJapanMexicoNetherlandsPolandPuerto RicoRomaniaSlovakiaSouth KoreaSpainTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06292013primaryCompletionDate: changed
LOWMay 24, 2026NCT06292013studyFirstPostDate: changed