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

Completed · Phase 2 · Has a placebo group

Conditions studied: Neuropathic Pain, Distal Sensory Polyneuropathy

In brief

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.

Key facts

Study ID

NCT06568042

Run by

Eli Lilly and Company

People needed

558

Starts

2024-08-22

Expected to finish

2026-04-15

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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
• MD First Research - Chandler — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.