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LY3079514

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: Oct 4, 2018

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
NCT02242903A Study of LY3079514 in Healthy ParticipantsPHASE1 COMPLETED 48 — — Oct 1, 2014Jun 1, 2015Oct 4, 20181 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 to Study Completion (Up to 12 Weeks)

An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of SAEs, regardless of causality, is located in the Reported Adverse Events module.

Secondary Endpoints
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514
SC Dosing-Predose,4hr,12hr,24hr,Day(D)3,D5,D8,D11,D15,D22,D29,D43,D57,D85; IV Dosing- D1 and D2 End of Infusion,4hr,12hr,24hr,D3,D8,D15,D22,D29,D36,D43,D57,D85
PK: Area Under the Concentration Curve Zero to Infinity (AUC 0-∞) of LY3079514
SC Dosing-Predose,4hr,12hr,24hr,Day(D)3,D5,D8,D11,D15,D22,D29,D43,D57,D85; IV Dosing- D1 and D2 End of Infusion,4hr,12hr,24hr,D3,D8,D15,D22,D29,D36,D43,D57,D85
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3079514EXPERIMENTALSingle dose of LY3079514 administered intravenous (IV) or subcutaneous (SC) during a single occasion
PlaceboPLACEBO_COMPARATORSingle dose of placebo matching LY3079514 administered IV infusion or SC injection during a single occasion.
Interventions
NameTypeDescription
LY3079514DRUGAdministered SC
PlaceboDRUGAdministered SC
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Overtly healthy participants as determined by medical history and physical examination * To qualify as Japanese for the purpose of this study, the Japanese participant must be first-generation Japanese * Have a body mass index (BMI) between 18.5 and 32.0 kilograms per square m...

Countries:United States
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