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LY3848575

Phase 2

Neuropathic Pain | Small molecule | Neurology |Eli Lilly and Company|Last Updated: Jul 10, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment558

FDA Designations

No designations recorded

Clinical trial landscape

LY3848575 · 2 trials · 3 indications

Phase 2 1Phase 1 1
NCT06568042Effects of LY3848575 Versus Placebo in Participants With Painful Distal Sensory PolyneuropathyNeuropathic Pain
COMPLETED558 Analytics
PHASE2COMPLETED
Effects of LY3848575 Versus Placebo in Participants With Painful Distal Sensory Polyneuropathy
Neuropathic PainUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS)
Baseline, Week 12
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline through 142 days

A summary of TEAEs, SAEs and Other Non-serious Adverse Events (AEs), Regardless of causality, will be reported in the Reported Adverse Events module

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.
LY3848575 IVEXPERIMENTALSingle ascending doses of LY3848575 administered intravenously (IV).
Placebo IVPLACEBO_COMPARATORPlacebo administered IV.
LY3848575 SCEXPERIMENTALMultiple doses of LY3848575 administered subcutaneously (SC).
Placebo SCPLACEBO_COMPARATORPlacebo administered SC.

Interventions

NameTypeDescription
LY3848575DRUGAdministered SC
PlaceboDRUGAdministered SC
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Eligibility Criteria

Age Range18 Years to 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)

MEDIUMAug 10, 2026NCT06568042TRIAL_REMOVED: changed
MEDIUMAug 10, 2026NCT06568042TRIAL_REMOVED: changed
HIGHJul 10, 2026NCT06568042Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJul 10, 2026NCT06568042Status: ACTIVE_NOT_RECRUITING → COMPLETED

Frequently asked questions about LY3848575

What is LY3848575 used for?

LY3848575 is an investigational small molecule being studied for neuropathic pain, specifically painful distal sensory polyneuropathy. It has also been evaluated in healthy participants. The drug is being developed by Eli Lilly and Company and is currently in clinical development.

Who makes LY3848575?

LY3848575 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is an investigational small molecule in clinical development for neuropathic pain.

What phase is LY3848575 in?

LY3848575 is in clinical development. A Phase 1 study in healthy participants has been completed, and a Phase 2 study in participants with painful distal sensory polyneuropathy has also been completed. The drug is investigational and not yet approved.

What clinical trials is LY3848575 in?

LY3848575 has been studied in two completed clinical trials. NCT05727072 was a Phase 1 study in healthy participants in the United States. NCT06568042 was a Phase 2 study comparing LY3848575 to placebo in participants with painful distal sensory polyneuropathy, conducted across multiple countries.

Is LY3848575 being studied in a placebo-controlled trial?

Yes, LY3848575 has been studied in a placebo-controlled trial. The Phase 2 study NCT06568042 compared LY3848575 against placebo in participants with painful distal sensory polyneuropathy. This trial was randomized and double-blind, with 558 participants enrolled.