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Effects of LY3848575 Versus Placebo in Participants With Painful Distal Sensory Polyneuropathy

CompletedPhase 2NCT06568042
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

Brief summary (from the registry)

The purpose of this study is to evaluate how safe and how well a treatment works compared to placebo for people with nerve pain that begins in their feet and moves up the leg to just below the knee. Participation may last up to 30 weeks including screening.

Study details

Official title
A Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Finding Study Evaluating LY3848575 in Chronic Neuropathic Pain Associated With Distal Sensory Polyneuropathy
Conditions
Interventions
Sponsor
Eli Lilly and Company
Start date
2024-08-22
Primary completion
2026-01-12
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
Canada, Germany, Japan, Mexico, Poland, South Korea, United States
Total sites listed
76

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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, such as metabolic, toxic exposure, nutritional, immunologic, infectious, hereditary, multifactorial, or no known cause identified (idiopathic), of symmetrical nature and in lower extremities (with or without involvement of the hands). * Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain- relieving therapies and/or nutritional supplements and will not start any new nonpharmacologic pain-relieving therapies and/or nutritional supplements during study participation. * Are willing to discontinue all medications taken for chronic pain conditions, except the allowed pain medications. * Individuals NOT of childbearing potential may participate in the trial. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: * Other etiologies of pain that may not be due to DSP or confound the assessment due to painful DSP. * Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest. * Have not achieved glycemic control on a stable diabetes treatment regimen for at least 90 days prior to screening, have a healthcare provider who manages the participants' diabetes, and have a hemoglobin A1c (HbA1c) \>11% at screening. * Cancer within 2 years of baseline, except for: * cutaneous basal cell or squamous cell carcinoma resolved by excision, or * cancer treatment which led to chemotherapy that caused distal sensory polyneuropathy. * Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide. * Have a surgery planned during the study for any reason. * History of chronic alcohol, illicit drug, or narcotic use disorder within 2 years prior to screening.

Canadian sites (7)

FacilityCityProvince
Med Trust ResearchCourtice
Dawson Clinical Research Inc.Guelph
Premier Clinical Trial NetworkHamilton
OCT Research ULCKelowna
Genge PartnersMontreal
Richmond Clinical TrialsRichmond
Bluewater Clinical Research Group Inc.Sarnia
Canadian sites for NCT06568042CourticeGuelphHamiltonKelownaMontrealRichmondSarnia
Canadian sites for NCT06568042. 7 mapped locations with coordinates in the registry. Schematic plot, not to scale.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06568042