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LY2608204

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Nov 16, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01247363A Study of LY2608204 in Patients With Type 2 DiabetesPHASE1 COMPLETED 20Nov 1, 2010Mar 1, 2011Nov 16, 20182 United States, Singapore
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Study Endpoints
Primary Endpoints
Number of Participants With Clinically Significant Adverse Effects
Day 1 through Day 49

Clinically significant adverse effects refer to any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the medicinal investigational product.

Secondary Endpoints
Area Under the Concentration Time Curve (AUC)
Predose, 1, 2, 4, 6, 7, 10, 12 and 24 hours Postdose
Maximum Drug Concentration (Cmax)
Predose, 1, 2, 4, 6, 7, 10, 12, 24, 48, 120 and 168 hours Postdose
Time to Maximum Drug Concentration (Tmax)
Predose, 1, 2, 4, 6, 7, 10, 12, 24, 48, 120 and 168 hours Postdose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
LY2608204EXPERIMENTALOral capsules of LY2608204 given once daily at a starting dose of 160 milligram (mg), which may be titrated in 3 dose escalations to 240 mg, 320 mg and 400 mg, with a 7-day treatment duration at each dose level for up to 28 days total treatment.
Interventions
NameTypeDescription
LY2608204DRUGAdministered orally.
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Patients diagnosed with Type 2 diabetes mellitus (T2DM) who are currently treated with diet/lifestyle measures alone or in combination with anti-diabetic agents, including insulins * Have fasting blood glucose (FBG) greater than or equal to 160 milligram/deciliter (mg/dL), wit...

Countries:United StatesSingapore
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