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LY2922083

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Aug 8, 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
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01748552A Study of LY2922083 in Healthy Participants and Participants With DiabetesPHASE1 COMPLETED 36 — — Dec 1, 2012Aug 1, 2013Aug 8, 20191 Singapore
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Study Endpoints
Primary Endpoints
Number of Participants With 1 or More Serious Adverse Event(s) (SAEs)
Baseline through study completion (up to 70 days)

Events deemed by the Investigator to be SAEs related to study drug administration are reported. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Secondary Endpoints
Pharmacokinetics (PK): Area Under the Concentration Curve From Time 0 to Infinite Time [AUC(0-∞)] of LY2922083
Predose up to 72 hours (h) after each dose of study drug (Part A: predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose. Part B: predose, 0.5, 1.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose.)
PK: Maximum Concentration (Cmax) of LY2922083
Predose up to 72 h after each dose of study drug (Part A: predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose. Part B: predose, 0.5, 1.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose.)
Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time 0 to 24 h Postdose [AUEC(0-24)]
Baseline (predose for Part A and Day -1 time-matched for Part B), up to 24 h postdose (1.5, 2.5, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18, and 24 h postdose)
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Placebo (Part A)PLACEBO_COMPARATORSingle oral dose of placebo administered to healthy participants in up to 1 of 3 study periods in Part A
LY2922083 (Part A)EXPERIMENTALSingle ascending dose of LY2922083 (starting at 0.5 milligrams \[mg\]) administered orally to healthy participants in up to 2 of 3 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
LY2922083 (Part B)EXPERIMENTALSingle ascending dose of LY2922083 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
LY2922083DRUGAdministered orally as capsules
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Eligibility Criteria
Age Range21 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 18.0 kilograms per square meter (kg/m\^2) * Have blood pressure, pulse rate,...

Countries:Singapore
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