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LY3325656

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Aug 23, 2018

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 Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03115099A Study of LY3325656 in Healthy Participants and Participants With Type 2 DiabetesPHASE1 COMPLETED 80 — — May 31, 2017Apr 5, 2018Aug 23, 20182 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 through approximately 12 weeks and 5 weeks after first administration of study drug in Parts A and B, respectively

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: Area Under the Concentration Curve (AUC) of LY3325656
Baseline up to 72 hours after each dose of study drug
Pharmacokinetics: Maximum Concentration (Cmax) of LY3325656
Baseline up to 72 hours after each dose of study drug
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Placebo (Part A)PLACEBO_COMPARATORSingle oral dose of placebo (sugar pill) administered to healthy participants in up to 1 study period in Part A
LY3325656 (Part A)EXPERIMENTALSingle ascending dose of LY3325656 administered orally to healthy participants in up to 3 study periods in Part A
Placebo (Part B)PLACEBO_COMPARATORSingle oral dose of placebo (sugar pill) administered to participants with T2DM in 1 study period in Part B
LY3325656 (Part B)EXPERIMENTALSingle oral dose of LY3325656 administered to participants with T2DM in 1 study period in Part B
Liraglutide (Part B)ACTIVE_COMPARATORSingle subcutaneous dose of liraglutide administered to participants with T2DM in 1 study period in Part B
LY3325656 + Sitagliptin (Part B)EXPERIMENTALSingle oral dose of LY3325656 and sitagliptin administered to participants with T2DM in 1 study period in Part B
Interventions
NameTypeDescription
LY3325656DRUGAdministered orally
PlaceboDRUGAdministered orally
LiraglutideDRUGAdministered subcutaneously
SitagliptinDRUGAdministered orally
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Eligibility Criteria
Age Range21 Years — 70 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: For all participants: * 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 screening body mass index (BMI) of at least 18.5 kilograms per square meter (kg/m²) * Have blood pressure, pulse rate, bl...

Countries:Singapore
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