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LY3143753

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Mar 13, 2019

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_CONTROLLED
Total Trials1
Total Enrollment68
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02342314A Study of LY3143753 and LY3185643 in Healthy ParticipantsPHASE1 COMPLETED 68 — — Jan 1, 2015Sep 1, 2016Mar 13, 20191 United Kingdom
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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 84 Days)

A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

Secondary Endpoints
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Part A
Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
PK: Cmax of Part B
Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
PK: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Part A
Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3143753 (Part A)EXPERIMENTALSingle subcutaneous (SC) injection of ascending doses of LY3143753 on Day 1
LY3185643 (Part B)EXPERIMENTALSingle SC injection of ascending doses of LY3185643 on Day 1
Placebo (Part A)PLACEBO_COMPARATORSingle SC injection of normal saline on Day 1
rGlucagon (Part B)ACTIVE_COMPARATORSingle SC injection on Day 1
Placebo (Part B)PLACEBO_COMPARATORSingle SC injection of normal saline on Day 1
Interventions
NameTypeDescription
LY3143753 (Part A)DRUGAdministered via SC injection
LY3185643 (Part B)DRUGAdministered via SC injection
Placebo (Part A and Part B)DRUGAdministered via SC injection
rGlucagon (Part B)DRUGAdministered via SC injection
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Overtly healthy males or females * Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures Exclusion Criteria: * Are investigator site personnel directly affiliated with this study and their immediate fam...

Countries:United Kingdom
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