A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain

Last updated: July 3, 2026
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Placebo

LY4065967

Clinical Study ID

NCT07285018
27370
H0P-MC-CPMP
H0P-MC-NP07
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to test the safety and efficacy of study drug LY4065967 for the treatment of diabetic peripheral neuropathic pain (DPNP). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 (©University of Michigan)

  • Have a history and current diagnosis of type 1 or type 2 diabetes mellitus.

  • Have an HbA1c <11% and on a stable regimen for treatment of diabetes at least 90days prior to screening

  • Have a body mass index at screening of ≤40 kilogram per meter squared (kg/m2)

Exclusion

Exclusion Criteria:

  • Are pregnant or breastfeeding

  • Have a history of other potentially causative and/or confounding sources of painthat may impair self-assessment of pain due to diabetic peripheral neuropathic pain (DPNP)

  • Have lower limb amputation due to diabetes inclusive of great toe (metatarsal bone)

  • Have serum vitamin B12 ≤200 picogram per milliliter (pg/mL)

  • Have an abnormal BP (systolic BP >140 mm Hg and diastolic BP>90 mm Hg) at screening

  • Have history or current clinically significant cardiac disease, includingarrhythmia, aortic aneurysm, heart failure, current electrolyte abnormalities, orany other conditions that could predispose to arrhythmia in the judgement of theinvestigator

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
February 16, 2026
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • Ponce Medical School Foundation Inc.

    Ponce, 00716
    Puerto Rico

    Active - Recruiting

  • Central Research Associates

    Birmingham, Alabama 35205
    United States

    Active - Recruiting

  • Arizona Research Center

    Phoenix, Arizona 85053
    United States

    Active - Recruiting

  • Synexus Clinical Research US, Inc.

    Phoenix, Arizona 85020
    United States

    Active - Recruiting

  • Arizona Research Center

    Phoenix 5308655, Arizona 5551752 85053
    United States

    Active - Recruiting

  • Central Phoenix Medical Clinic

    Phoenix 5308655, Arizona 5551752 85020
    United States

    Site Not Available

  • Desert Oasis Healthcare Medical Group

    Palm Springs, California 92262
    United States

    Active - Recruiting

  • Artemis Institute for Clinical Research

    Riverside, California 92503
    United States

    Active - Recruiting

  • Artemis Institute for Clinical Research

    San Diego, California 92123
    United States

    Active - Recruiting

  • Artemis Institute for Clinical Research

    San Diego 5391811, California 5332921 92103
    United States

    Site Not Available

  • CMR of Greater New Haven

    Hamden, Connecticut 06517
    United States

    Active - Recruiting

  • Bradenton Research Center, Inc.

    Bradenton, Florida 34205
    United States

    Active - Recruiting

  • Accel Research Sites - DeLand Clinical Research Unit

    DeLand, Florida 32720
    United States

    Active - Recruiting

  • K2 MEDICAL Research THE VILLAGES

    Lady Lake, Florida 32159
    United States

    Active - Recruiting

  • K2 Medical Research ORLANDO

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Merritt Island Medical Research, LLC

    Merritt Island, Florida 32952
    United States

    Active - Recruiting

  • New Horizon Research Center

    Miami, Florida 33165
    United States

    Active - Recruiting

  • Suncoast Research Group

    Miami, Florida 33135
    United States

    Active - Recruiting

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida 34652
    United States

    Active - Recruiting

  • Renstar Medical Research

    Ocala, Florida 34470
    United States

    Active - Recruiting

  • Precision Clinical Research

    Sunrise, Florida 33351
    United States

    Active - Recruiting

  • Charter Research - Lady Lake

    The Villages, Florida 32162
    United States

    Active - Recruiting

  • Conquest Research

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • Suncoast Research Group

    Miami 4164138, Florida 4155751 33135
    United States

    Active - Recruiting

  • North Georgia Clinical Research

    Woodstock, Georgia 30189
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • DelRicht Research

    New Orleans, Louisiana 70115
    United States

    Active - Recruiting

  • Lucida Clinical Trials

    New Bedford, Massachusetts 02740
    United States

    Active - Recruiting

  • MedVadis Research Corporation

    Waltham, Massachusetts 02451
    United States

    Active - Recruiting

  • Great Lakes Research Group, Inc.

    Bay City, Michigan 48706
    United States

    Active - Recruiting

  • StudyMetrix Research

    City of Saint Peters, Missouri 63303
    United States

    Active - Recruiting

  • Clinvest Research LLC

    Springfield, Missouri 65807
    United States

    Active - Recruiting

  • Rochester Clinical Research, LLC

    Rochester, New York 14609
    United States

    Active - Recruiting

  • Lillestol Research

    Fargo, North Dakota 58104
    United States

    Active - Recruiting

  • META Medical Research Institute

    Dayton, Ohio 45432
    United States

    Active - Recruiting

  • DelRicht Research

    Tulsa, Oklahoma 74133
    United States

    Active - Recruiting

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Active - Recruiting

  • FutureSearch Trials of Neurology

    Austin, Texas 78731
    United States

    Active - Recruiting

  • Re:Cognition Health - Fort Worth

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Active - Recruiting

  • Rainier Clinical Research Center

    Renton, Washington 98057
    United States

    Active - Recruiting

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