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LY2828360

Phase 2

Osteoarthritis, Knee | Small molecule | Musculoskeletal |Eli Lilly and Company|Last Updated: May 19, 2020

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment39
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01319929A Study of LY2828360 in Patients With Osteoarthritic Knee PainPHASE2 COMPLETED 39Mar 1, 2011Sep 1, 2011May 19, 20201 Denmark
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Study Endpoints
Primary Endpoints
Change From Baseline to 4 Week Endpoint in Weekly Mean of Daily 24-Hour Average Pain Scores (APS)
Baseline, 4 weeks

The weekly mean of the 24-Hour APS was calculated from participants' daily entries for 24-hour average pain rating on an 11-point scale with scores from 0 (no pain) to 10 (worst possible pain). Data were recorded twice a day at approximately the same time each day, preferably first thing in the morning and in the afternoon.

Secondary Endpoints
Pharmacokinetics (PK) of LY2828360: Maximal Concentration (Cmax)
Pre-last dose to 8 hours post-last dose (at end of each 4-week treatment period)
Pharmacokinetics (PK) of LY2828360: Area Under the Concentration-Time Curve (AUC)
Pre-last dose to 8 hours post-last dose (at end of each 4-week treatment period)
Change From Baseline to 4 Week Endpoint in Weekly Mean of Night Pain and Worst Daily Pain Scores
Baseline, 4 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
LY2828360 then PlaceboEXPERIMENTAL80 milligrams (mg) of LY2828360 daily by mouth for 4 weeks: placebo daily by mouth for 4 weeks. There is a washout period of 3 weeks between treatments.
Placebo then LY2828360EXPERIMENTALPlacebo daily by mouth for 4 weeks: LY2828360 daily by mouth for 4 weeks. There is a washout period of 3 weeks between treatments.
Interventions
NameTypeDescription
LY2828360DRUGAdministered orally
PlaceboDRUGAdministered orally
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Eligibility Criteria
Age Range40 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Are male or female participants with osteoarthritis (OA), as determined by medical history and physical examination. Males and females with stable medical problems that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the...

Countries:Denmark
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