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LY3461767 -

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Feb 5, 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
NCT04352114A Study of LY3461767 in Healthy ParticipantsPHASE1 COMPLETED 48 — — Jun 15, 2020Jan 13, 2021Feb 5, 20213 United States, Singapore
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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 through Day 29

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): Maximum Observed Drug Concentration (Cmax) of LY3461767
Baseline through Day 29
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3461767
Baseline through Day 29
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3461767 - Subcutaneous (SC)EXPERIMENTALLY3461767 administered SC.
Placebo - SCPLACEBO_COMPARATORPlacebo administered SC.
LY3461767 - Intravenous (IV)EXPERIMENTALLY3461767 administered IV.
Interventions
NameTypeDescription
LY3461767 - SCDRUGAdministered SC.
LY3461767 - IVDRUGAdministered IV.
Placebo - SCDRUGAdministered SC.
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Eligibility Criteria
Age Range21 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Are healthy males, or females of non-child-bearing potential * Have a body mass index of 18 to 35 kilograms per square meter (kg/m²) * Have clinical laboratory tests within normal ranges as judged by investigator * Have pulse rate and blood pressure within normal ranges as jud...

Countries:United StatesSingapore
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