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

NCT06568042 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 18825J4F-MC-CYAB2024-513435-24-00
• Study Type: interventional
• Target: 558
• Locations: 7 countries
• Sites: 76

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.

Conditions

Neuropathic Pain; Distal Sensory Polyneuropathy

Keywords

Peripheral Neuropathy; Diabetic Peripheral Neuropathy; Chemotherapy Induced Peripheral Neuropathy; HIV Induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Mean Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS)

  Baseline, Week 12

Secondary Outcomes (10)

• 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

Study Arms (4)

LY3848575 Dose 1

EXPERIMENTAL

LY3848575 low dose administered subcutaneously (SC).

Drug: LY3848575

LY3848575 Dose 2

EXPERIMENTAL

LY3848575 mid dose administered SC.

Drug: LY3848575

LY3848575 Dose 3

EXPERIMENTAL

LY3848575 high dose administered SC.

Drug: LY3848575

Placebo

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

Interventions

LY3848575 DRUG

Administered SC

LY3848575 Dose 1; LY3848575 Dose 2; LY3848575 Dose 3

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (76)

MD First Research - Chandler

Chandler, Arizona, 85286, United States

Location

HOPE Research Institute

Phoenix, Arizona, 85032, United States

Location

Neuro-Pain Medical Center

Fresno, California, 93710, United States

Location

Alpine Clinical Research Center

Boulder, Colorado, 80301, United States

Location

Accel Research Sites - St. Pete-Largo Clinical Research Unit

Largo, Florida, 33777, United States

Location

Design Neuroscience Center

Miami Lakes, Florida, 33016, United States

Location

Conquest Research - Orlando

Orlando, Florida, 32832, United States

Location

Charter Research - Lady Lake

The Villages, Florida, 32162, United States

Location

Encore Medical Research - Weston

Weston, Florida, 33331, United States

Location

Conquest Research

Winter Park, Florida, 32789, United States

Location

Integrated Clinical Trial Services, Inc.

West Des Moines, Iowa, 50265, United States

Location

Lucida Clinical Trials

New Bedford, Massachusetts, 02740, United States

Location

SKY Integrative Medical Center/SKYCRNG

Ridgeland, Mississippi, 39157, United States

Location

StudyMetrix Research

City of Saint Peters, Missouri, 63303, United States

Location

Mid Hudson Medical Research

New Windsor, New York, 12553, United States

Location

University of Rochester Medical Center

Rochester, New York, 14618, United States

Location

Asheville Neurology Specialists, PA

Asheville, North Carolina, 28806, United States

Location

Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Neurology Diagnostics, Inc.

Dayton, Ohio, 45459, United States

Location

New Phase Research and Development

Knoxville, Tennessee, 37909, United States

Location

Cedar Health Research

Dallas, Texas, 75251, United States

Location

Biopharma Informatic, LLC

Houston, Texas, 77043, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Med Trust Research

Courtice, L1E 2J5, Canada

Location

Dawson Clinical Research Inc.

Guelph, N1H 1B1, Canada

Location

Premier Clinical Trial Network

Hamilton, L8L5G4, Canada

Location

OCT Research ULC

Kelowna, V1Y 1Z9, Canada

Location

Genge Partners

Montreal, H4A 3T2, Canada

Location

Richmond Clinical Trials

Richmond, V6V 2L1, Canada

Location

Bluewater Clinical Research Group Inc.

Sarnia, N7T 4X3, Canada

Location

FutureMeds GmbH

Berlin, 10629, Germany

Location

Studienzentrum Dr. Bischof GmbH

Böblingen, 71034, Germany

Location

Universitaetsklinikum Schleswig-Holstein Campus Kiel

Kiel, 24105, Germany

Location

ZNS Siegen

Siegen, 57076, Germany

Location

Studienzentrum Nord-West

Westerstede, 26655, Germany

Location

St. Luke's International Hospital

Chūōku, 104-8560, Japan

Location

Chugoku Central Hospital

Fukuyama-shi, 720-0001, Japan

Location

Mito Medical Center

Higashiibaraki, 311-3117, Japan

Location

Rinku General Medical Center

Izumisano, 598-8577, Japan

Location

Sagara Hospital

Kagoshima, 892-0833, Japan

Location

Kamezawa Clinic

Kasugai, 486-0817, Japan

Location

The Cancer Institute Hospital of JFCR

Kōtō City, 135-8550, Japan

Location

Kikuchi Naika Clinic

Maebashi, 370-3573, Japan

Location

Aizawa Hospital

Matsumoto, 390-0814, Japan

Location

Kojunkai Daido Hospital

Nagoya, 457-8511, Japan

Location

Nishinomiya Municipal Central Hospital

Nishinomiya, 663-8014, Japan

Location

Medical Corporation Sato Medical clinic

Ootaku, 143-0015, Japan

Location

Minamiosaka Hospital

Osaka, 559-0012, Japan

Location

Fujigaki Clinic

Ōita, 870-0942, Japan

Location

Saga-Ken Medical Centre Koseikan

Saga, 840-8571, Japan

Location

Asama General Hospital

Saku, 385-0022, Japan

Location

Tokyo Shinagawa Hospital

Shinagawa-ku, 140-8522, Japan

Location

Niwa Family Clinic

Tokyo, 182-0006, Japan

Location

Scientia Investigacion Clinica S.C.

Chihuahua City, 31207, Mexico

Location

Investigación Clínica Cuernavaca, S.C.

Cuernavaca, 62448, Mexico

Location

Centro de Investigación Clínica y Medicina Traslacional (CIMeT)

Guadalajara, 44340, Mexico

Location

Health Pharma Querétaro

Juriquilla, 76230, Mexico

Location

Grupo Medico Camino Sc

Mexico City, 03310, Mexico

Location

Medical Care and Research SA de CV

Mérida, 97070, Mexico

Location

Cicmex Centro de Investigación Clínica de México

Morelia, 58000, Mexico

Location

Centro de Investigacion Clinica de Oaxaca

Oaxaca City, 68020, Mexico

Location

Podlaskie Centrum Psychogeriatrii

Bialystok, 15-756, Poland

Location

Centrum Medyczne NEUROMED

Bydgoszcz, 85-163, Poland

Location

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, 80-546, Poland

Location

Neuro-Care Sp. z o.o. sp. kom.

Katowice, 40-749, Poland

Location

Diamond Clinic

Krakow, 31-559, Poland

Location

Santa Familia PTG Lodz

Lodz, 90-302, Poland

Location

Nzoz Neuro-Kard Ilkowski i Partnerzy SPL

Poznan, 61-853, Poland

Location

MICS Centrum Medyczne Warszawa - Chłodna

Warsaw, 00-872, Poland

Location

Chosun University Hospital

Gwangju, 61453, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

The Catholic Univ. of Korea Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Related Links

• Related Info

MeSH Terms

Conditions

Neuralgia; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 23, 2024
• Study Start: August 22, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

KR (6); CA (7); JP (18); DE (5); US (24); ME (8); PL (8)