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LY3473329

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment233

FDA Designations

No designations recorded

Clinical trial landscape

LY3473329 · 5 trials · 3 indications

Phase 2 1Phase 1 4
NCT05563246A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular EventsLipoprotein Disorder
COMPLETED233 Analytics
PHASE2COMPLETED
A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events
Lipoprotein DisorderUnlock trial analytics

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.

Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Day 1 up to Day 29 post dose
Part 1: Fecal Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Day 1 up to Day 29 post dose
Part 2: Pharmacokinetics (PK): Absolute bioavailability (F) of LY3473329
Day 1 up to Day 9 post dose

Part 2: PK: F of LY3473329

Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3473329
Predose up to 34 days postdose

PK: AUC0-∞ of LY3473329

PK: Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3473329
Predose up to 34 days postdose

PK: AUC0-tlast of LY3473329

PK: Maximum observed concentration (Cmax) of LY3473329
Predose up to 34 days postdose

PK: Cmax of LY3473329

Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline through Day 43

A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline up to Day 137

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

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.
[14C]-LY3473329 (Part 1)EXPERIMENTALSingle dose of \[¹⁴C\]-LY3473329 administered orally
LY3473329 + [14C]-LY3473329 (Part 2)EXPERIMENTALSingle dose of LY3473329 administered orally followed by a single dose of \[¹⁴C\]-LY3473329 administered intravenously (IV)
LY3473329 (Control)EXPERIMENTALLY3473329 administered orally to participants with normal renal function
LY3473329 (Mild Renal Impairment)EXPERIMENTALLY3473329 administered orally to participants with mild renal impairment
LY3473329 (Moderate Renal Impairment)EXPERIMENTALLY3473329 administered orally to participants with moderate renal impairment
LY3473329 (Severe Renal Impairment)EXPERIMENTALLY3473329 administered orally to participants with severe renal impairment
LY3473329 (End-Stage Renal Disease)EXPERIMENTALLY3473329 administered orally to participants with end-stage renal disease
LY3473329EXPERIMENTALLY3473329 administered orally.
LY3473329 (Part A)EXPERIMENTALLY3473329 administered orally.
Placebo (Part A)PLACEBO_COMPARATORPlacebo administered orally.
LY3473329 (Part B)EXPERIMENTALLY3473329 administered orally.
Placebo (Part B)EXPERIMENTALPlacebo administered orally.

Interventions

NameTypeDescription
LY3473329DRUGAdministered orally
PlaceboDRUGAdministered orally
[14C]-LY3473329DRUGAdministered orally
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Eligibility Criteria

Age Range40 Years to 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 StatesAustraliaBrazilChinaGermanyHungaryJapanNetherlandsUnited Kingdom
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Frequently asked questions about LY3473329

What is LY3473329 used for?

LY3473329 is an investigational small molecule being studied for use in healthy participants, in people with renal insufficiency, and in adults with elevated lipoprotein(a) who are at high risk for cardiovascular events. It is being developed by Eli Lilly and Company and is currently in clinical development.

What does LY3473329 target?

LY3473329 is a small molecule being studied for its effects on lipoprotein(a) levels. It is being investigated in adults with elevated lipoprotein(a) who are at high risk for cardiovascular events, suggesting it targets pathways related to lipoprotein(a) metabolism.

Who makes LY3473329?

LY3473329 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug's safety and efficacy.

What phase is LY3473329 in?

LY3473329 is in Phase 2 clinical development. It has completed Phase 1 trials in healthy participants and a Phase 2 trial in adults with elevated lipoprotein(a) at high risk for cardiovascular events. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is LY3473329 in?

LY3473329 has completed several clinical trials, including NCT04472676 and NCT05038787 in healthy participants, NCT05563246 in adults with elevated lipoprotein(a), and NCT06342596 in healthy male participants. These trials were conducted in multiple countries, including the United States, Netherlands, and Japan.

Is LY3473329 the same as any other drug?

LY3473329 is the primary identifier for this investigational drug. No alternative names have been reported for this compound. It is being studied under this designation in clinical trials registered with ClinicalTrials.gov.