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LY3192767

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Apr 5, 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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment57
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03025009A Study of LY3192767 in Healthy ParticipantsPHASE1 COMPLETED 57Mar 6, 2017Apr 11, 2018Apr 5, 20191 Germany
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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 Study Completion (up to about Day 49)

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): Time to Maximum Concentration (Tmax) of LY3192767
Predose through 336 Hours
PK: Maximum Serum Concentration (Cmax) of LY3192767
Predose through 336 Hours
PK: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC[0-inf] of LY3192767
Predose through 336 Hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3192767 (Part A)EXPERIMENTALEscalating doses of LY3192767 administered subcutaneously (SC).
Placebo (Part A)PLACEBO_COMPARATORPlacebo matching LY3192767 administered subcutaneously (SC).
LY3192767 (Part B)EXPERIMENTALLY3192767 administered as a SC injection in one of three study periods.
Basal Insulin Peglispro (Part B)ACTIVE_COMPARATORBasal insulin peglispro administered as a SC injection in one of three study periods.
Insulin Glargine (Part B)ACTIVE_COMPARATORInsulin glargine administered as a SC injection in one of three study periods.
Interventions
NameTypeDescription
LY3192767DRUGAdministered SC.
Basal Insulin PeglisproDRUGAdministered SC.
Insulin GlargineDRUGAdministered SC.
PlaceboDRUGAdministered SC.
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Eligibility Criteria
Age Range20 Years — 64 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are overtly healthy males or females, as determined by medical history and physical examination * Have a body mass index (BMI) of \>18.5 and \<30.0 kilogram per square meter (kg/m²), inclusive Exclusion Criteria: * Are currently enrolled in a clinical trial involving an inve...

Countries:Germany
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