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LY3475766 -

Phase 1

Dyslipidemias | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Apr 28, 2021

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 Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04052594A Study of LY3475766 in Healthy ParticipantsPHASE1 COMPLETED 48Sep 3, 2019Mar 31, 2021Apr 28, 20214 United States
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Study Endpoints
Primary Endpoints
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 85

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
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3475766
Predose up to Day 85
PK: Maximum Observed Drug Concentration (Cmax) of LY3475766
Predose up to Day 85
PK: Time to Maximum Observed Drug Concentration (Tmax) of LY3475766
Predose up to Day 85
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3475766 - IVEXPERIMENTALLY3475766 administered intravenously (IV) to participants with dyslipidemia
Placebo - IVPLACEBO_COMPARATORPlacebo administered IV to participants with dyslipidemia
LY3475766 - SCEXPERIMENTALLY3475766 administered subcutaneously (SC) to participants with dyslipidemia
Placebo - SCPLACEBO_COMPARATORPlacebo administered SC to participants with dyslipidemia
Interventions
NameTypeDescription
LY3475766 - IVDRUGAdministered IV
LY3475766 - SCDRUGAdministered SC
Placebo - IVDRUGAdministered IV
Placebo - SCDRUGAdministered SC
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Are overtly healthy males or females, apart from dyslipidemia * Male participants must agree to adhere to contraception restrictions * Female participants must be of nonchildbearing potential and include those who are infertile due to surgical sterilization or those who are po...

Countries:United States
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