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
Sites (76)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Med Trust Research Coordinator of this site? Confirm its status | Courtice | Canada | Unknown status |
| Dawson Clinical Research Inc. Coordinator of this site? Confirm its status | Guelph | Canada | Unknown status |
| Premier Clinical Trial Network Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| OCT Research ULC Coordinator of this site? Confirm its status | Kelowna | Canada | Unknown status |
| Genge Partners Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Richmond Clinical Trials Coordinator of this site? Confirm its status | Richmond | Canada | Unknown status |
| Bluewater Clinical Research Group Inc. Coordinator of this site? Confirm its status | Sarnia | Canada | Unknown status |
| FutureMeds GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Studienzentrum Dr. Bischof GmbH Coordinator of this site? Confirm its status | Böblingen | Germany | Unknown status |
| Universitaetsklinikum Schleswig Holstein Campus Kiel Coordinator of this site? Confirm its status | Kiel | Germany | Unknown status |
| ZNS Siegen Coordinator of this site? Confirm its status | Siegen | Germany | Unknown status |
| Studienzentrum Nord-West Coordinator of this site? Confirm its status | Westerstede | Germany | Unknown status |
| St. Luke's International Hospital Coordinator of this site? Confirm its status | Chūōku | Japan | Unknown status |
| Chugoku Central Hospital Coordinator of this site? Confirm its status | Fukuyama-shi | Japan | Unknown status |
| Mito Medical Center Coordinator of this site? Confirm its status | Higashiibaraki | Japan | Unknown status |
| Rinku General Medical Center Coordinator of this site? Confirm its status | Izumisano | Japan | Unknown status |
| Sagara Hospital Coordinator of this site? Confirm its status | Kagoshima | Japan | Unknown status |
| Kamezawa Clinic Coordinator of this site? Confirm its status | Kasugai | Japan | Unknown status |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Kōtō City | Japan | Unknown status |
| Kikuchi Naika Clinic Coordinator of this site? Confirm its status | Maebashi | Japan | Unknown status |
| Aizawa Hospital Coordinator of this site? Confirm its status | Matsumoto | Japan | Unknown status |
| Kojunkai Daido Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Nishinomiya Municipal Central Hospital Coordinator of this site? Confirm its status | Nishinomiya | Japan | Unknown status |
| Fujigaki Clinic Coordinator of this site? Confirm its status | Ōita | Japan | Unknown status |
| Medical Corporation Sato Medical clinic Coordinator of this site? Confirm its status | Ootaku | Japan | Unknown status |
| Minamiosaka Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Saga-ken Medical Centre Koseikan Coordinator of this site? Confirm its status | Saga | Japan | Unknown status |
| Asama General Hospital Coordinator of this site? Confirm its status | Saku | Japan | Unknown status |
| Tokyo Shinagawa Hospital Coordinator of this site? Confirm its status | Shinagawa-ku | Japan | Unknown status |
| Niwa Family Clinic Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Chosun University Hospital Coordinator of this site? Confirm its status | Gwangju | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Konkuk University Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic Univ. of Korea Seoul St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Scientia Investigacion Clinica S.C. Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Unknown status |
| Investigación Clínica Cuernavaca, S.C. Coordinator of this site? Confirm its status | Cuernavaca | Mexico | Unknown status |
| Centro de Investigación Clínica y Medicina Traslacional (CIMeT) Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Health Pharma Querétaro Coordinator of this site? Confirm its status | Juriquilla | Mexico | Unknown status |
| Medical Care and Research Sa de Cv Coordinator of this site? Confirm its status | Mérida | Mexico | Unknown status |
| Grupo Medico Camino Sc Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Cicmex Centro de Investigación Clínica de México Coordinator of this site? Confirm its status | Morelia | Mexico | Unknown status |
| Centro de Investigacion Clinica de Oaxaca Coordinator of this site? Confirm its status | Oaxaca City | Mexico | Unknown status |
| Podlaskie Centrum Psychogeriatrii Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
| Centrum Medyczne NEUROMED Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Unknown status |
| Centrum Badan Klinicznych PI-House sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Neuro-Care Sp. z o.o. sp. kom. Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Diamond Clinic Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Santa Familia Ptg Lodz Coordinator of this site? Confirm its status | Lodz | Poland | Unknown status |
| Nzoz Neuro-Kard Ilkowski i Partnerzy SPL Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| MICS Centrum Medyczne Warszawa - Chłodna Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Asheville Neurology Specialists PA Coordinator of this site? Confirm its status | Asheville | United States | Unknown status |
| Northwest Clinical Research Center Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| Alpine Clinical Research Center Coordinator of this site? Confirm its status | Boulder | United States | Unknown status |
| MD First Research - Chandler Coordinator of this site? Confirm its status | Chandler | United States | Unknown status |
| StudyMetrix Research Coordinator of this site? Confirm its status | City of Saint Peters | United States | Unknown status |
| Cedar Health Research Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Neurology Diagnostics, Inc. Coordinator of this site? Confirm its status | Dayton | United States | Unknown status |
| Neuro-Pain Medical Center Coordinator of this site? Confirm its status | Fresno | United States | Unknown status |
| Clinical Trial Network Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Biopharma Informatic, LLC Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| New Phase Research And Development Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| Accel Research Sites - St. Pete-Largo Clinical Research Unit Coordinator of this site? Confirm its status | Largo | United States | Unknown status |
| Design Neuroscience Center Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Lucida Clinical Trials Coordinator of this site? Confirm its status | New Bedford | United States | Unknown status |
| Mid Hudson Medical Research Coordinator of this site? Confirm its status | New Windsor | United States | Unknown status |
| Conquest Research - Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Hope Research Institute Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| SKY Integrative Medical Center/SKYCRNG Coordinator of this site? Confirm its status | Ridgeland | United States | Unknown status |
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Charter Research - Lady Lake Coordinator of this site? Confirm its status | The Villages | United States | Unknown status |
| Integrated Clinical Trial Services, Inc. Coordinator of this site? Confirm its status | West Des Moines | United States | Unknown status |
| Encore Medical Research - Weston Coordinator of this site? Confirm its status | Weston | United States | Unknown status |
| Center for Clinical Research Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
| Conquest Research Coordinator of this site? Confirm its status | Winter Park | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.