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LY3016859 ISA

Phase 2

Osteoarthritis, Knee | Small molecule | Neurology |Eli Lilly and Company|Last Updated: Apr 20, 2026

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-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment10,000
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05986292A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic PainPHASE2 RECRUITING 10,000Jan 30, 2020Apr 1, 2027Apr 20, 202664 United States, Puerto Rico
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Study Endpoints
Primary Endpoints
Number of Participants Who Were Allocated to Each ISA
Baseline, Up to Week 8
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeSCREENING
Treatment Arms
ArmTypeDescription
LY3016859 Osteoarthritis ISAEXPERIMENTALParticipants are randomized to receive either active LY3016859 or matching placebo
LY3016859 Diabetic Neuropathic Pain ISAEXPERIMENTALParticipants are randomized to receive either active LY3016859 or matching placebo
LY3016859 Chronic Back Pain ISAEXPERIMENTALParticipants are randomized to receive either active LY3016859 or matching placebo
LY3556050 Osteoarthritis ISAEXPERIMENTALParticipants are randomized to receive either active LY3556050 or matching placebo
LY3556050 Diabetic Neuropathic Pain ISAEXPERIMENTALParticipants are randomized to receive either active LY3556050 or matching placebo
LY3556050 Chronic Back Pain ISAEXPERIMENTALParticipants are randomized to receive either active LY3556050 or matching placebo
LY3526318 Osteoarthritis ISAEXPERIMENTALParticipants are randomized to receive either active LY3526318 or matching placebo
LY3526318 Diabetic Neuropathic Pain ISAEXPERIMENTALParticipants are randomized to receive either active LY3526318 or matching placebo
LY3526318 Chronic Back Pain ISAEXPERIMENTALParticipants are randomized to receive either active LY3526318 or matching placebo
LY3857210 Osteoarthritis ISAEXPERIMENTALParticipants are randomized to receive either active LY3857210 or matching placebo
LY3857210 Diabetic Neuropathic Pain ISAEXPERIMENTALParticipants are randomized to receive either active LY3857210 or matching placebo
LY3857210 Chronic Back Pain ISAEXPERIMENTALParticipants are randomized to receive either active LY3857210 or matching placebo
Interventions
NameTypeDescription
LY3016859 ISADRUGAdministered intravenously (IV)
LY3556050 ISADRUGAdministered orally
LY3526318 ISADRUGAdministered orally
LY3857210 ISADRUGAdministered orally
Placebo OralDRUGPlacebo administered orally
PlaceboDRUGPlacebo administered IV
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites64

Inclusion Criteria: * have a visual analog scale (VAS) pain value \>40 and \<95 at screening and prerandomization screening. * have a history of daily pain for at least 12 weeks based on participant report or medical history * have a value of ≤30 on the pain catastrophizing scale * have a body mass...

Countries:United StatesPuerto Rico
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05986292primaryCompletionDate: changed
LOWMay 24, 2026NCT05986292studyFirstPostDate: changed