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LY4065967

Phase 2

Diabetic Peripheral Neuropathic Pain | Small molecule | Neurology |Eli Lilly and Company|Last Updated: Mar 27, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07285018A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic PainPHASE2 RECRUITING 150Feb 16, 2026Jul 1, 2027Mar 27, 202637 United States, Puerto Rico
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Study Endpoints
Primary Endpoints
Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
Baseline, Week 8
Secondary Endpoints
Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score
Baseline, Week 8
Change from Baseline in Overall Improvement as Measured by Patient's Global Impression of Change (PGI-C)
Baseline, Week 8
Change from Baseline in Worst Pain Intensity as Measured by NRS
Baseline, Week 8
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY4065967EXPERIMENTALParticipants will receive LY4065967 orally.
PlaceboPLACEBO_COMPARATORParticipants will receive placebo orally.
Interventions
NameTypeDescription
LY4065967DRUGAdministered orally
PlaceboDRUGAdministered orally
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites37

Inclusion Criteria: * Have presence of diabetic peripheral neuropathy, of symmetrical nature and in lower extremities for ≥6 months and diagnosed by a score of Part B ≥3 on Michigan Neuropathy Screening Instrument (©University of Michigan) * Have a history and current diagnosis of type 1 or type 2 ...

Countries:United StatesPuerto Rico
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07285018primaryCompletionDate: changed
LOWMay 24, 2026NCT07285018studyFirstPostDate: changed