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LY3374849 -

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Oct 17, 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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment89
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03726125A Study of LY3374849 in Healthy ParticipantsPHASE1 COMPLETED 89Nov 20, 2018Sep 27, 2019Oct 17, 20191 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 up to study completion (estimated at 11 weeks)

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
Glucodynamics: Total Amount of Glucose Infused (Gtot)
Baseline up to 36 hours post-dose for each study arm
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3374849
Baseline at predose through 6 days post-dose for each study arm
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3374849 - SC (Part A)EXPERIMENTALSingle subcutaneous (SC) dose of LY3374849
Insulin Degludec - SC (Part A)EXPERIMENTALSingle SC dose of insulin degludec
LY3374849 - SC (Part B)EXPERIMENTALSingle dose of LY3374849 administered SC in up to three of three study periods
LY3374849 - IV (Part B)EXPERIMENTALSingle dose of LY3374849 administered intravenously (IV) in up to one of three study periods
LY3374849 - IV (Part C)EXPERIMENTALSingle IV dose of LY3374849 in one of two study periods
Insulin Degludec - IV (Part C)EXPERIMENTALSingle IV dose of insulin degludec in one of two study periods
Interventions
NameTypeDescription
LY3374849 - SCDRUGAdministered SC
Insulin Degludec - SCDRUGAdministered SC
LY3374849 - IVDRUGAdministered IV
Insulin Degludec - IVDRUGAdministered IV
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Eligibility Criteria
Age Range21 Years — 70 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or a female who cannot become pregnant * Have a body mass index (BMI) of at least 18 kilogram per square meter (kg/m²) * Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study * Ha...

Countries:Singapore
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