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

Phase 2

Recruiting

• Conditions: Neuropathic Pain; Distal Sensory Polyneuropathy
• Interventions: Drug: LY3848575; 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

Study Timeline

• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-08-21
• Study Start: 2024-08-22
• Study First Posted: 2024-08-23
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-25
• Primary Completion: 2026-06
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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.

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 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
Mean Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS)	Baseline, Week 12

Trial Locations

Locations (81)

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

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