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LY3108743 -

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Jul 15, 2014

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 Enrollment44
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01995656A Study of LY3108743 in Healthy Participants and Participants With Type 2 DiabetesPHASE1 COMPLETED 44 — — Dec 1, 2013Apr 1, 2014Jul 15, 20141 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
Pre-dose up to Day 6 (5 days post-dose)
Secondary Endpoints
Maximum Change from Baseline up to 24 Hours in Level of Blood Glucose Before and After a Standard Meal
Baseline up to 24 hours
Pharmacokinetics: Maximum Concentration (Cmax) of LY3108743
Baseline up to 48 hours
Pharmacokinetics: Area Under the Curve (AUC) of LY3108743
Baseline up to 48 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Placebo - HealthyPLACEBO_COMPARATORPart A. Healthy participants will receive a single oral dose of placebo matching LY3108732 in at least 1 of 3 study periods.
LY3108743 - HealthyEXPERIMENTALPart A. Healthy participants will receive a single oral dose of LY3108743 in dose escalation cohorts in up to 2 of 3 study periods.
Placebo - DiabetesPLACEBO_COMPARATORPart B. Participants with diabetes mellitus will receive a single oral dose of placebo matching LY3108732 in at least 1 of 3 study periods.
LY3108743 - DiabetesEXPERIMENTALPart B. Participants with diabetes mellitus will receive a single oral dose of LY3108743 in dose escalation cohorts in up to 2 of 3 study periods.
Placebo - SolutionPLACEBO_COMPARATORPart C. Contingent on results from Parts A and B. Healthy participants will receive a single oral dose of placebo matching LY3108743 in 1 of 2 study periods.
LY3108743 - SolutionEXPERIMENTALPart C. Contingent on results from Parts A and B. Healthy participants will receive a single oral dose of LY3108743 in 1 of 2 study periods.
Interventions
NameTypeDescription
Placebo - CapsuleDRUGAdministered orally
LY3108743 - CapsuleDRUGAdministered orally
Placebo - SolutionDRUGAdministered orally
LY3108743 - SolutionDRUGAdministered orally
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Eligibility Criteria
Age Range21 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes * Have a body mass index (BMI) of 18.5 to 40.0 kilogram per square meter (kg/m\^2), inclusive, at screening * Have normal blood pressure * Participants w...

Countries:Singapore
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