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LY3848575

Phase 2

Neuropathic Pain | Small molecule | Neurology |Eli Lilly and Company|Last Updated: Apr 29, 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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment558
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06568042Effects of LY3848575 Versus Placebo in Participants With Painful Distal Sensory PolyneuropathyPHASE2 ACTIVE NOT_RECRUITING 558Aug 22, 2024Sep 1, 2026Apr 29, 202676 United States, Canada +5
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Study Endpoints
Primary Endpoints
Mean Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS)
Baseline, Week 12
Secondary Endpoints
Mean Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS)
Baseline, Week 12
Mean Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Custom Form (CF) v1.1
Baseline, Week 12
Mean Change from Baseline in Pain Interference with Sleep
Baseline, Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY3848575 Dose 1EXPERIMENTALLY3848575 low dose administered subcutaneously (SC).
LY3848575 Dose 2EXPERIMENTALLY3848575 mid dose administered SC.
LY3848575 Dose 3EXPERIMENTALLY3848575 high dose administered SC.
PlaceboPLACEBO_COMPARATORPlacebo administered SC.
Interventions
NameTypeDescription
LY3848575DRUGAdministered SC
PlaceboDRUGAdministered SC
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites76

Inclusion Criteria: * Have a Visual Analog Scale (VAS) pain value ≥40 and \<95 at screening. * Presence of painful distal sensory polyneuropathy (DSP) without prominent motor or autonomic features with gradual or insidious onset with a minimum duration of 6 months and a known cause of nerve injury,...

Countries:United StatesCanadaGermanyJapanMexicoPolandSouth Korea
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06568042Enrollment: 450 → 558
LOWMay 24, 2026NCT06568042studyFirstPostDate: changed