Skip to main content
OpenTrials
Completed

NCT Number: NCT06568042

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Med Trust Research, Courtice, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

LY3848575

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

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

    Time frame: Baseline, Week 12

Secondary outcomes

  1. Mean Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS)

    Time frame: Baseline, Week 12

  2. Mean Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Custom Form (CF) v1.1

    Time frame: Baseline, Week 12

  3. Mean Change from Baseline in Pain Interference with Sleep

    Time frame: Baseline, Week 12

  4. Mean Change from Baseline in PROMIS Short Form (SF) Physical Functioning (PF) 10a (PROMIS PF 10a)

    Time frame: Baseline, Week 12

  5. Mean Change from Baseline in PROMIS (SF) Sleep Disturbance 8b (PROMIS SD 8b)

    Time frame: Baseline, Week 12

  6. Mean Change from Baseline in 36-Item Short Form Health Survey Version 2 (SF-36 v2)

    Time frame: Baseline, Week 12

  7. Mean Change from Baseline in Patient's Global Impression (PGI) of Illness Severity as Measured by PGI-Severity

    Time frame: Baseline, Week 12

  8. Mean Overall Improvement as Measured by Patient's Global Impression of Change

    Time frame: Week 12

  9. Use of Rescue Medication

    Time frame: Baseline up to Week 12

  10. Pharmacokinetic (PK): Serum Concentration of LY3848575

    Time frame: Baseline up to Week 12

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Finding Study Evaluating LY3848575 in Chronic Neuropathic Pain Associated With Distal Sensory Polyneuropathy

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 23, 2024
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.