Effects of LY3848575 Versus Placebo in Participants With Painful Distal Sensory Polyneuropathy
- Conditions
- Neuropathic PainDistal Sensory Polyneuropathy
- Interventions
- Drug: Placebo
- Registration Number
- NCT06568042
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
- 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.
-
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.
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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.
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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.
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Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
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Have a surgery planned during the study for any reason.
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History of chronic alcohol, illicit drug, or narcotic use disorder within 2 years prior to screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3848575 Dose 1 LY3848575 LY3848575 low dose administered subcutaneously (SC). LY3848575 Dose 2 LY3848575 LY3848575 mid dose administered SC. LY3848575 Dose 3 LY3848575 LY3848575 high dose administered SC. Placebo Placebo Placebo administered SC.
- Primary Outcome Measures
Name Time Method Mean Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Baseline, Week 12
- Secondary Outcome Measures
Name Time Method 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 Mean Change from Baseline in PROMIS Short Form (SF) Physical Functioning (PF) 10a (PROMIS PF 10a) Baseline, Week 12 Mean Change from Baseline in PROMIS (SF) Sleep Disturbance 8b (PROMIS SD 8b) Baseline, Week 12 Mean Change from Baseline in 36-Item Short Form Health Survey Version 2 (SF-36 v2) Baseline, Week 12 Mean Change from Baseline in Patient's Global Impression (PGI) of Illness Severity as Measured by PGI-Severity Baseline, Week 12 Mean Overall Improvement as Measured by Patient's Global Impression of Change Week 12 Use of Rescue Medication Baseline up to Week 12 Pharmacokinetic (PK): Serum Concentration of LY3848575 Baseline up to Week 12
Related Research Topics
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Trial Locations
- Locations (83)
Alpine Clinical Research Center
🇺🇸Boulder, Colorado, United States
emovis GmbH
🇩🇪Berlin, Germany
MD First Research - Chandler
🇺🇸Chandler, Arizona, United States
HOPE Research Institute
🇺🇸Phoenix, Arizona, United States
Neuro-Pain Medical Center
🇺🇸Fresno, California, United States
The Los Angeles Headache Center
🇺🇸Los Angeles, California, United States
First Choice Neurology - Aventura Neurology
🇺🇸Aventura, Florida, 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
🇺🇸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
OCT Research ULC
🇨🇦Kelowna, British Columbia, Canada
Richmond Clinical Trials
🇨🇦Richmond, British Columbia, Canada
Med Trust Research
🇨🇦Courtice, Ontario, Canada
Dawson Clinical Research Inc.
🇨🇦Guelph, Ontario, Canada
Premier Clinical Trial Network
🇨🇦Hamilton, Ontario, Canada
Bluewater Clinical Research Group Inc.
🇨🇦Sarnia, Ontario, Canada
Genge Partners
🇨🇦Montreal, Quebec, Canada
MUDr. Alena Vachova
🇨🇿Ceske Budejovice, Jihočeský Kraj, Czechia
MUDr. Miroslav Koliba s.r.o.
🇨🇿Ostrava, Ostrava Město, Czechia
NEUROS s.r.o.
🇨🇿Pilsen, Plzeň-město, Czechia
Milan Kvapil s.r.o., Diabetologicka ambulance
🇨🇿Praha, Praha 4, Czechia
Praglandia s.r.o
🇨🇿Praha 5, Czechia
Studienzentrum Dr. Bischof GmbH
🇩🇪Boeblingen, Baden-Württemberg, Germany
Studienzentrum Nord-West
🇩🇪Westerstede, Niedersachsen, Germany
ZNS Siegen
🇩🇪Siegen, Nordrhein-Westfalen, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel
🇩🇪Kiel, Schleswig-Holstein, Germany
Kamezawa Clinic
🇯🇵Kasugai, Aichi, Japan
Kojunkai Daido Hospital
🇯🇵Nagoya, Aichi, Japan
Kikuchi Naika Clinic
🇯🇵Maebashi, Gunma, Japan
Chugoku Central Hospital
🇯🇵Fukuyama-shi, Hiroshima, Japan
Nishinomiya Municipal Central Hospital
🇯🇵Nishinomiya, Hyogo, Japan
Mito Medical Center
🇯🇵Higashiibaraki, Ibaraki, Japan
Aizawa Hospital
🇯🇵Matsumoto, Nagano, Japan
Asama General Hospital
🇯🇵Saku, Nagano, Japan
Rinku General Medical Center
🇯🇵Izumisano, Osaka, Japan
Saga-Ken Medical Centre Koseikan
🇯🇵Saga-shi, Saga, Japan
St. Luke's International Hospital
🇯🇵Chuo-ku, Tokyo, Japan
Medical Corporation Sato Medical clinic
🇯🇵Ootaku, Tokyo, Japan
Tokyo Shinagawa Hospital
🇯🇵Shinagawa-ku, Tokyo, Japan
NTT Medical Center Tokyo
🇯🇵Shinagawa-ku, Tokyo, Japan
Sagara Hospital
🇯🇵Kagoshima, Japan
Fujigaki Clinic
🇯🇵Oita, Japan
Minamiosaka Hospital
🇯🇵Osaka, Japan
Niwa Family Clinic
🇯🇵Tokyo, Japan
Chosun University Hospital
🇰🇷Gwangju, Kwangju-Kwangyǒkshi, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
The Catholic Univ. of Korea Seoul St. Mary's Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Grupo Medico Camino Sc
🇲🇽Mexico City, Distrito Federal, Mexico
Centro de Investigación Clínica y Medicina Traslacional (CIMeT)
🇲🇽Guadalajara, Jalisco, Mexico
Cicmex Centro de Investigación Clínica de México
🇲🇽Morelia, Michoacán, Mexico
Investigación Clínica Cuernavaca, S.C.
🇲🇽Cuernavaca, Morelos, Mexico
Centro de Investigacion Clinica de Oaxaca
🇲🇽Oaxaca de Juarez, Oaxaca, Mexico
Health Pharma Querétaro
🇲🇽Juriquilla, Querétaro, Mexico
Medical Care and Research SA de CV
🇲🇽Merida, Yucatán, Mexico
Scientia Investigacion Clinica S.C.
🇲🇽Chihuahua, Mexico
Centrum Medyczne NEUROMED
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
MICS Centrum Medyczne Warszawa
🇵🇱Warszawa, Mazowieckie, Poland
Diamond Clinic
🇵🇱Krakow, Małopolskie, Poland
Podlaskie Centrum Psychogeriatrii
🇵🇱Białystok, Podlaskie, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
🇵🇱Gdansk, Pomorskie, Poland
Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
🇵🇱Poznan, Wielkopolskie, Poland
Santa Familia PTG Lodz
🇵🇱Lodz, Łódzkie, Poland
Neuro-Care Sp. z o.o. sp. kom.
🇵🇱Katowice, Śląskie, Poland