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Muvalaplin

Phase 3

Elevated Lp(a) | Small molecule | Other |Eli Lilly and Company|Last Updated: Jun 3, 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_CONTROLLEDDMC
Total Trials1
Total Enrollment10,450
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07157774Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a)PHASE3 RECRUITING 10,450 — — Sep 2, 2025Mar 1, 2031Jun 3, 2026752 United States, Argentina +25
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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 5.25 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
Percent Change from Baseline in Lipoprotein(a) (Lp(a)) at Week 4
Baseline, Week 4
Time to First Occurrence of Any Component of the MACE-3 Composite Endpoint
Baseline up to End of Study (About 5.25 Years)
Time to First Occurrence of Any Component of the Modified MACE-3 Composite Endpoint
Baseline up to End of Study (About 5.25 Years)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MuvalaplinEXPERIMENTALParticipants will receive muvalaplin orally.
PlaceboPLACEBO_COMPARATORParticipants will receive placebo orally.
Interventions
NameTypeDescription
MuvalaplinDRUGAdministered orally
PlaceboDRUGAdministered orally
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites752

Inclusion Criteria: * Have Lp(a) ≥175 nanomoles per liter (nmol/L) * Meet one of the following criteria: * Have had a prior atherosclerotic cardiovascular disease (ASCVD) event (such as heart attack, stroke, or procedure to restore blood flow to the heart or other parts of the body) within 10 ye...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilCanadaChinaCzechiaDenmarkFranceGermanyGreeceHungaryIndiaItalyJapanMexicoNetherlandsPolandPuerto RicoRomaniaSlovakiaSouth KoreaSpainTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)
LOWJun 3, 2026NCT07157774lastUpdatePostDate: changed
LOWJun 3, 2026NCT07157774lastUpdatePostDate: changed
LOWMay 26, 2026NCT07157774primaryCompletionDate: changed
LOWMay 24, 2026NCT07157774studyFirstPostDate: changed