Effects of LY3848575 Versus Placebo in Participants With Painful Distal Sensory Polyneuropathy
NCT ID: NCT06568042
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
450 participants
INTERVENTIONAL
2024-08-22
2026-09-30
Brief Summary
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Participation may last up to 30 weeks including screening.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LY3848575 Dose 1
LY3848575 low dose administered subcutaneously (SC).
LY3848575
Administered SC
LY3848575 Dose 2
LY3848575 mid dose administered SC.
LY3848575
Administered SC
LY3848575 Dose 3
LY3848575 high dose administered SC.
LY3848575
Administered SC
Placebo
Placebo administered SC.
Placebo
Administered SC
Interventions
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LY3848575
Administered SC
Placebo
Administered SC
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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MD First Research - Chandler
Chandler, Arizona, United States
HOPE Research Institute
Phoenix, Arizona, United States
Neuro-Pain Medical Center
Fresno, California, United States
Alpine Clinical Research Center
Boulder, Colorado, United States
Accel Research Sites - St. Pete-Largo Clinical Research Unit
Largo, Florida, United States
Design Neuroscience Center
Miami Lakes, Florida, United States
Conquest Research - Orlando
Orlando, Florida, United States
Charter Research - Lady Lake
The Villages, Florida, United States
Encore Medical Research - Weston
Weston, Florida, United States
Conquest Research
Winter Park, Florida, United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, United States
Lucida Clinical Trials
New Bedford, Massachusetts, United States
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, United States
StudyMetrix Research
City of Saint Peters, Missouri, United States
Mid Hudson Medical Research
New Windsor, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Asheville Neurology Specialists, PA
Asheville, North Carolina, United States
Center for Clinical Research
Winston-Salem, North Carolina, United States
Neurology Diagnostics, Inc.
Dayton, Ohio, United States
New Phase Research and Development
Knoxville, Tennessee, United States
Cedar Health Research
Dallas, Texas, United States
Biopharma Informatic, LLC
Houston, Texas, United States
Clinical Trial Network
Houston, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Med Trust Research
Courtice, , Canada
Dawson Clinical Research Inc.
Guelph, , Canada
Premier Clinical Trial Network
Hamilton, , Canada
OCT Research ULC
Kelowna, , Canada
Genge Partners
Montreal, , Canada
Richmond Clinical Trials
Richmond, , Canada
Bluewater Clinical Research Group Inc.
Sarnia, , Canada
FutureMeds GmbH
Berlin, , Germany
Studienzentrum Dr. Bischof GmbH
Böblingen, , Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, , Germany
ZNS Siegen
Siegen, , Germany
Studienzentrum Nord-West
Westerstede, , Germany
St. Luke's International Hospital
Chūōku, , Japan
Chugoku Central Hospital
Fukuyama-shi, , Japan
Mito Medical Center
Higashiibaraki, , Japan
Rinku General Medical Center
Izumisano, , Japan
Sagara Hospital
Kagoshima, , Japan
Kamezawa Clinic
Kasugai, , Japan
The Cancer Institute Hospital of JFCR
Kōtō City, , Japan
Kikuchi Naika Clinic
Maebashi, , Japan
Aizawa Hospital
Matsumoto, , Japan
Kojunkai Daido Hospital
Nagoya, , Japan
Nishinomiya Municipal Central Hospital
Nishinomiya, , Japan
Medical Corporation Sato Medical clinic
Ootaku, , Japan
Minamiosaka Hospital
Osaka, , Japan
Fujigaki Clinic
Ōita, , Japan
Saga-Ken Medical Centre Koseikan
Saga, , Japan
Asama General Hospital
Saku, , Japan
Tokyo Shinagawa Hospital
Shinagawa-ku, , Japan
Niwa Family Clinic
Tokyo, , Japan
Scientia Investigacion Clinica S.C.
Chihuahua City, , Mexico
Investigación Clínica Cuernavaca, S.C.
Cuernavaca, , Mexico
Centro de Investigación Clínica y Medicina Traslacional (CIMeT)
Guadalajara, , Mexico
Health Pharma Querétaro
Juriquilla, , Mexico
Grupo Medico Camino Sc
Mexico City, , Mexico
Medical Care and Research SA de CV
Mérida, , Mexico
Cicmex Centro de Investigación Clínica de México
Morelia, , Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, , Mexico
Podlaskie Centrum Psychogeriatrii
Bialystok, , Poland
Centrum Medyczne NEUROMED
Bydgoszcz, , Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, , Poland
Neuro-Care Sp. z o.o. sp. kom.
Katowice, , Poland
Diamond Clinic
Krakow, , Poland
Santa Familia PTG Lodz
Lodz, , Poland
Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
Poznan, , Poland
MICS Centrum Medyczne Warszawa - Chłodna
Warsaw, , Poland
Chosun University Hospital
Gwangju, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, , South Korea
Countries
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Related Links
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Related Info
Other Identifiers
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J4F-MC-CYAB
Identifier Type: OTHER
Identifier Source: secondary_id
2024-513435-24-00
Identifier Type: CTIS
Identifier Source: secondary_id
18825
Identifier Type: -
Identifier Source: org_study_id