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LY3185643

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Sep 30, 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 Enrollment23
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02951780A Study of LY3185643 and rGlucagon in Healthy ParticipantsPHASE1 COMPLETED 23 — — Nov 1, 2016Mar 1, 2017Sep 30, 20191 Singapore
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Study Endpoints
Primary Endpoints
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3185643 and rGlucagon
0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose

Maximum observed plasma concentration (Cmax) was assessed for LY3185643 and rGlucagon.

Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3185643 and rGlucagon
0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose

Area under the concentration versus time curve from zero to infinity (AUC0-inf) was assessed for LY3185643 and rGlucagon.

Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of Blood Glucose of LY3185643 and rGlucagon
-5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dose

Cmax was assessed for LY3185643 and rGlucagon.

Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of C-peptide of LY3185643 and rGlucagon
-5, 0 (predose), 5, 15, 30, 60 and 120 minutes post-dose

Cmax was assessed for C-peptide of LY3185643 and rGlucagon

Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of Blood Glucose of LY3185643 and rGlucagon
-5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dose

Area under the concentration versus time curve from time zero to 3 hours \[AUC (0-3)\] was assessed for LY3185643 and rGlucagon.

Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of C-Peptide of LY3185643 and rGlucagon
-5, 0 (pre-dose), 5, 15, 30, 60 and 120 minutes post-dose

Area under the concentration versus time curve from time zero to 3 hours \[AUC (0-3)\] was assessed for C-peptide of LY3185643 and rGlucagon.

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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3185643EXPERIMENTALLY3185643 administered subcutaneous (SC)
rGlucagonEXPERIMENTALrGlucagon administered subcutaneous (SC)
Interventions
NameTypeDescription
LY3185643DRUGAdministered SC
rGlucagonDRUGAdministered SC
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Eligibility Criteria
Age Range21 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are overtly healthy as determined by medical history and physical examination * Body mass index of 18.0 to 30.0 kilograms per square meter (kg/m²) Exclusion Criteria: * Have participated, within the last 30 days, in a clinical trial involving an investigational product * Kno...

Countries:Singapore
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