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LY2922470

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Jun 3, 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 Trials2
Total Enrollment92
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01867216A Study of Multiple Doses of LY2922470 in Participants With DiabetesPHASE1 COMPLETED 66 — — Jun 1, 2013Jan 1, 2014Jul 26, 20184 United States
NCT01746017A Study of LY2922470 in Healthy Participants and Participants With DiabetesPHASE1 COMPLETED 26 — — Dec 1, 2012Mar 1, 2013Jun 3, 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 through Study Completion (up to 56 days)

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is located in the Reported Adverse Events module.

Secondary Endpoints
Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470
Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose
Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470
Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdose
Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470
Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORMultiple oral dose of placebo administered to participants with diabetes once or twice daily for 28 days
LY2922470EXPERIMENTALMultiple ascending dose of LY292470 (starting at 60 mg) administered orally to participants with diabetes once or twice daily for 28 days
Placebo (Part A)PLACEBO_COMPARATORSingle oral dose of placebo administered to healthy participants in up to 1 of 4 study periods in Part A
LY2922470 (Part A)EXPERIMENTALSingle ascending dose of LY2922470 \[starting at 1 milligram (mg)\] administered orally to healthy participants in up to 3 of 4 study periods in Part A
Placebo (Part B)PLACEBO_COMPARATORSingle oral dose of placebo administered to participants with type 2 diabetes mellitus (T2DM) in up to 1 of 3 study periods in Part B
LY2922470 (Part B)EXPERIMENTALSingle ascending dose of LY2922470 administered orally to participants with T2DM in up to 2 of 3 study periods in Part B. Dose determined by Part A
Interventions
NameTypeDescription
PlaceboDRUGAdministered orally as capsules
LY2922470DRUGAdministered orally as capsules
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Must be a male, or a female who cannot become pregnant, and who has type 2 diabetes * Have a glycated hemoglobin (HbA1c) value of greater than or equal to 6.5% and less than or equal to 11% at screening * Do not have any change to their diabetes treatment (exercise with or wit...

Countries:United StatesSingapore
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