Fact CheckerSign in

NCT06568042CompletedPhase 2

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

A Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Finding Study Evaluating LY3848575 in Chronic Neuropathic Pain Associated With Distal Sensory Polyneuropathy

Source: ClinicalTrials.gov · Last updated 10 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
558 (actual)
First submitted
21 Aug 2024
Start date
22 Aug 2024
Primary completion date
12 Jan 2026
Lead sponsor
Eli Lilly and Company
NCT number
NCT06568042
EU CT number
2024-513435-24-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 558
  • From 22 Aug 2024 to the primary completion date, 12 Jan 2026
  • 76 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.

Lab values

  • 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.

Other

  • 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.
  • Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (76)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Med Trust Research
Coordinator of this site? Confirm its status
CourticeCanadaUnknown status
Dawson Clinical Research Inc.
Coordinator of this site? Confirm its status
GuelphCanadaUnknown status
Premier Clinical Trial Network
Coordinator of this site? Confirm its status
HamiltonCanadaUnknown status
OCT Research ULC
Coordinator of this site? Confirm its status
KelownaCanadaUnknown status
Genge Partners
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
Richmond Clinical Trials
Coordinator of this site? Confirm its status
RichmondCanadaUnknown status
Bluewater Clinical Research Group Inc.
Coordinator of this site? Confirm its status
SarniaCanadaUnknown status
FutureMeds GmbH
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
Studienzentrum Dr. Bischof GmbH
Coordinator of this site? Confirm its status
BöblingenGermanyUnknown status
Universitaetsklinikum Schleswig Holstein Campus Kiel
Coordinator of this site? Confirm its status
KielGermanyUnknown status
ZNS Siegen
Coordinator of this site? Confirm its status
SiegenGermanyUnknown status
Studienzentrum Nord-West
Coordinator of this site? Confirm its status
WesterstedeGermanyUnknown status
St. Luke's International Hospital
Coordinator of this site? Confirm its status
ChūōkuJapanUnknown status
Chugoku Central Hospital
Coordinator of this site? Confirm its status
Fukuyama-shiJapanUnknown status
Mito Medical Center
Coordinator of this site? Confirm its status
HigashiibarakiJapanUnknown status
Rinku General Medical Center
Coordinator of this site? Confirm its status
IzumisanoJapanUnknown status
Sagara Hospital
Coordinator of this site? Confirm its status
KagoshimaJapanUnknown status
Kamezawa Clinic
Coordinator of this site? Confirm its status
KasugaiJapanUnknown status
The Cancer Institute Hospital of JFCR
Coordinator of this site? Confirm its status
Kōtō CityJapanUnknown status
Kikuchi Naika Clinic
Coordinator of this site? Confirm its status
MaebashiJapanUnknown status
Aizawa Hospital
Coordinator of this site? Confirm its status
MatsumotoJapanUnknown status
Kojunkai Daido Hospital
Coordinator of this site? Confirm its status
NagoyaJapanUnknown status
Nishinomiya Municipal Central Hospital
Coordinator of this site? Confirm its status
NishinomiyaJapanUnknown status
Fujigaki Clinic
Coordinator of this site? Confirm its status
ŌitaJapanUnknown status
Medical Corporation Sato Medical clinic
Coordinator of this site? Confirm its status
OotakuJapanUnknown status
Minamiosaka Hospital
Coordinator of this site? Confirm its status
OsakaJapanUnknown status
Saga-ken Medical Centre Koseikan
Coordinator of this site? Confirm its status
SagaJapanUnknown status
Asama General Hospital
Coordinator of this site? Confirm its status
SakuJapanUnknown status
Tokyo Shinagawa Hospital
Coordinator of this site? Confirm its status
Shinagawa-kuJapanUnknown status
Niwa Family Clinic
Coordinator of this site? Confirm its status
TokyoJapanUnknown status
Chosun University Hospital
Coordinator of this site? Confirm its status
GwangjuSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Konkuk University Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Samsung Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Seoul National University Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Scientia Investigacion Clinica S.C.
Coordinator of this site? Confirm its status
Chihuahua CityMexicoUnknown status
Investigación Clínica Cuernavaca, S.C.
Coordinator of this site? Confirm its status
CuernavacaMexicoUnknown status
Centro de Investigación Clínica y Medicina Traslacional (CIMeT)
Coordinator of this site? Confirm its status
GuadalajaraMexicoUnknown status
Health Pharma Querétaro
Coordinator of this site? Confirm its status
JuriquillaMexicoUnknown status
Medical Care and Research Sa de Cv
Coordinator of this site? Confirm its status
MéridaMexicoUnknown status
Grupo Medico Camino Sc
Coordinator of this site? Confirm its status
Mexico CityMexicoUnknown status
Cicmex Centro de Investigación Clínica de México
Coordinator of this site? Confirm its status
MoreliaMexicoUnknown status
Centro de Investigacion Clinica de Oaxaca
Coordinator of this site? Confirm its status
Oaxaca CityMexicoUnknown status
Podlaskie Centrum Psychogeriatrii
Coordinator of this site? Confirm its status
BialystokPolandUnknown status
Centrum Medyczne NEUROMED
Coordinator of this site? Confirm its status
BydgoszczPolandUnknown status
Centrum Badan Klinicznych PI-House sp. z o.o.
Coordinator of this site? Confirm its status
GdanskPolandUnknown status
Neuro-Care Sp. z o.o. sp. kom.
Coordinator of this site? Confirm its status
KatowicePolandUnknown status
Diamond Clinic
Coordinator of this site? Confirm its status
KrakowPolandUnknown status
Santa Familia Ptg Lodz
Coordinator of this site? Confirm its status
LodzPolandUnknown status
Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
Coordinator of this site? Confirm its status
PoznanPolandUnknown status
MICS Centrum Medyczne Warszawa - Chłodna
Coordinator of this site? Confirm its status
WarsawPolandUnknown status
Asheville Neurology Specialists PA
Coordinator of this site? Confirm its status
AshevilleUnited StatesUnknown status
Northwest Clinical Research Center
Coordinator of this site? Confirm its status
BellevueUnited StatesUnknown status
Alpine Clinical Research Center
Coordinator of this site? Confirm its status
BoulderUnited StatesUnknown status
MD First Research - Chandler
Coordinator of this site? Confirm its status
ChandlerUnited StatesUnknown status
StudyMetrix Research
Coordinator of this site? Confirm its status
City of Saint PetersUnited StatesUnknown status
Cedar Health Research
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
Neurology Diagnostics, Inc.
Coordinator of this site? Confirm its status
DaytonUnited StatesUnknown status
Neuro-Pain Medical Center
Coordinator of this site? Confirm its status
FresnoUnited StatesUnknown status
Clinical Trial Network
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Biopharma Informatic, LLC
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
New Phase Research And Development
Coordinator of this site? Confirm its status
KnoxvilleUnited StatesUnknown status
Accel Research Sites - St. Pete-Largo Clinical Research Unit
Coordinator of this site? Confirm its status
LargoUnited StatesUnknown status
Design Neuroscience Center
Coordinator of this site? Confirm its status
Miami LakesUnited StatesUnknown status
Lucida Clinical Trials
Coordinator of this site? Confirm its status
New BedfordUnited StatesUnknown status
Mid Hudson Medical Research
Coordinator of this site? Confirm its status
New WindsorUnited StatesUnknown status
Conquest Research - Orlando
Coordinator of this site? Confirm its status
OrlandoUnited StatesUnknown status
Hope Research Institute
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status
SKY Integrative Medical Center/SKYCRNG
Coordinator of this site? Confirm its status
RidgelandUnited StatesUnknown status
University of Rochester Medical Center
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
Charter Research - Lady Lake
Coordinator of this site? Confirm its status
The VillagesUnited StatesUnknown status
Integrated Clinical Trial Services, Inc.
Coordinator of this site? Confirm its status
West Des MoinesUnited StatesUnknown status
Encore Medical Research - Weston
Coordinator of this site? Confirm its status
WestonUnited StatesUnknown status
Center for Clinical Research
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesUnknown status
Conquest Research
Coordinator of this site? Confirm its status
Winter ParkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.