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LY3473329

Phase 2

Lipoprotein Disorder | Small molecule | Other |Eli Lilly and Company|Last Updated: Mar 25, 2025

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment233
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05563246A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular EventsPHASE2 COMPLETED 233Nov 24, 2022Mar 14, 2024Mar 25, 202542 United States, Australia +6
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Study Endpoints
Primary Endpoints
Percent Change From Baseline in Lp(a) - Assessed Via Intact Lp(a) Assay
Baseline, Week 12

Least Squares Mean (LS Mean) was calculated using a Mixed Model for Repeated Measures (MMRM): Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Treatment + Time + Treatment\*Time.

Percent Change From Baseline in Lp(a) - Assessed Via Apo(a) Assay
Baseline, Week 12

LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Treatment + Time + Treatment\*Time.

Secondary Endpoints
Percentage of Participants Who Achieved Lp(a) < 125 Nmol/L - Assessed Via Intact Lp(a) Assay
Week 12
Percentage of Participants Who Achieved Lp(a) < 125 Nmol/L - Assessed Via Apo(a) Assay
Week 12
Percent Change From Baseline in Apolipoprotein B (ApoB)
Baseline, Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
10 mg LY3473329EXPERIMENTALParticipants received 10 milligrams (mg) of LY3473329 administered orally once daily (QD) over a 12-week treatment period.
60 mg LY3473329EXPERIMENTALParticipants received 60 mg of LY3473329 administered orally QD over a 12-week treatment period.
240 mg LY3473329EXPERIMENTALParticipants received 240 mg of LY3473329 administered orally QD over a 12-week treatment period.
PlaceboPLACEBO_COMPARATORParticipants received a matching dose of placebo administered orally QD over a 12-week treatment period.
Interventions
NameTypeDescription
LY3473329DRUGAdministered orally
PlaceboDRUGAdministered orally
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Eligibility Criteria
Age Range40 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites42

Inclusion Criteria: * Participants must be at least 40 years old * Participants with Lp(a) ≥175 nmol/L at randomization, measured at the central laboratory. * High risk for cardiovascular events defined as documented coronary artery disease (CAD), stroke, or peripheral artery disease or atheroscler...

Countries:United StatesAustraliaBrazilChinaGermanyHungaryJapanNetherlands
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