A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain

Last updated: January 23, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

2

Condition

Pain

Diabetic Neuropathy

Pain (Pediatric)

Treatment

LY3556050

Placebo

Clinical Study ID

NCT06074562
18509
2023-506127-29-00
J2P-MC-LXBD
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to determine the safety and efficacy of LY3556050 versus placebo in participants with diabetic peripheral neuropathic pain (DPNP). The study will lasts approximately 24 weeks, across 3 study periods.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a history and current diagnosis of Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D) diagnosed for at least 6 months prior to screening.

  • Have a stable glycemic control on stable diabetes treatment regimen for at least 90days prior to day 1 with a hemoglobin A1c (HbA1c) ≤10 for T1D and HbA1c ≤11 forparticipants with T2D at time of screening.

  • Have a history of daily peripheral neuropathic pain for at least 12 weeks based onparticipant report or medical history.

  • Have a visual analog scale (VAS) pain value ≥40 and <95 during screening.

  • Have presence of diabetic peripheral neuropathy of symmetrical nature and in lowerextremities for ≥6 months and diagnosed by a score of Part B ≥3 on MichiganNeuropathy Screening Instrument

  • Are willing to maintain a consistent regimen of any ongoing nonpharmacologicpain-relieving therapies (for example, physical therapy) and will not start any newnonpharmacologic pain-relieving therapies during study participation.

  • Are willing to discontinue all medications taken for chronic pain conditions, exceptallowed concomitant pain medication permitted per protocol, for the duration of thestudy

  • Have a body mass index ≤45 kilogram/square meter (kg/m²) (inclusive).

  • Are men, or women able to abide by reproductive and contraceptive requirements.

Exclusion

Exclusion Criteria:

  • History of other potentially causative and/or confounding sources of pain that mayimpair self-assessment of pain due to DPNP.

  • Have had a procedure within the past 6 months intended to produce permanent sensoryloss in the target area of interest (for example, ablation techniques.

  • Have had cancer within 2 years of baseline, except for cutaneous basal cell orsquamous cell carcinoma resolved by excision.

  • Are, in the judgment of the investigator, actively suicidal and therefore deemed tobe at significant risk for suicide.

  • Have in the judgement of the investigator, an acute, serious, or unstable medicalcondition or a history or presence of any other medical illness that would precludestudy participation.

  • Have a positive HIV test result at screening.

  • Have a surgery planned during the study for any reason.

  • Have a substance use disorder as defined by the Diagnostic and Statistical Manual ofMental Disorders (5th edition; DSM-5; American Psychiatric Association)

Study Design

Total Participants: 410
Treatment Group(s): 2
Primary Treatment: LY3556050
Phase: 2
Study Start date:
October 05, 2023
Estimated Completion Date:
July 31, 2025

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