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RecruitingPhase 2

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

Eli Lilly and Company · NCT07285018

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
150
US sites recruiting
36
Study start
February 16, 2026
Record last updated
July 7, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: LY4065967; Placebo

Conditions: Diabetic Peripheral Neuropathic Pain

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Have presence of diabetic peripheral neuropathy, of symmetrical nature and in lower extremities for ≥6 months and diagnosed by a score of Part B ≥3 on Michigan Neuropathy 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 90 days prior to screening
  • Have a body mass index at screening of ≤40 kilogram per meter squared (kg/m2)

Exclusion Criteria

  • Are pregnant or breastfeeding
  • Have a history of other potentially causative and/or confounding sources of pain that 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, including arrhythmia, aortic aneurysm, heart failure, current electrolyte abnormalities, or any other conditions that could predispose to arrhythmia in the judgement of the investigator

Recruiting US locations

  • Central Research Associates

    Birmingham, AL 35205

    Site contact: David DeAtkine

  • Synexus Clinical Research US, Inc.

    Phoenix, AZ 85020

    Site contact: Shawn Searle

  • Arizona Research Center

    Phoenix, AZ 85053

    Site contact: Louise Taber MD

  • Desert Oasis Healthcare Medical Group

    Palm Springs, CA 92262

    Site contact: Michael Jardula

  • Artemis Institute for Clinical Research

    Riverside, CA 92503

    Site contact: Jack Vu

  • Artemis Institute for Clinical Research

    San Diego, CA 92123

    Site contact: Stacey Layle

  • CMR of Greater New Haven

    Hamden, CT 06517

    Site contact: Joseph Soufer

  • Bradenton Research Center, Inc.

    Bradenton, FL 34205

    Site contact: Eric Folkens

  • Accel Research Sites - DeLand Clinical Research Unit

    DeLand, FL 32720

    Site contact: Bruce Rankin

  • K2 MEDICAL Research THE VILLAGES

    Lady Lake, FL 32159

    Site contact: Craig Curtis

  • K2 Medical Research ORLANDO

    Maitland, FL 32751

    Site contact: Brandon Lenox

  • Merritt Island Medical Research, LLC

    Merritt Island, FL 32952

    Site contact: David Kirk

  • Suncoast Research Group

    Miami, FL 33135

    Site contact: Mark Kutner

  • New Horizon Research Center

    Miami, FL 33165

    Site contact: Lazaro Nunez

  • Suncoast Clinical Research, Inc.

    New Port Richey, FL 34652

    Site contact: Cathy Barnes

  • Renstar Medical Research

    Ocala, FL 34470

    Site contact: David Oliver

  • Precision Clinical Research

    Sunrise, FL 33351

    Site contact: Richard Linn

  • Charter Research - Lady Lake

    The Villages, FL 32162

    Site contact: Stephen Miller

  • Conquest Research

    Winter Park, FL 32789

    Site contact: Anand Patel

  • North Georgia Clinical Research

    Woodstock, GA 30189

    Site contact: Bram Wieskopf

  • Northwestern University

    Chicago, IL 60611

    Site contact: Thomas Schnitzer

  • DelRicht Research

    New Orleans, LA 70115

    Site contact: Patrick Dennis

  • Lucida Clinical Trials

    New Bedford, MA 02740

    Site contact: David Shih

  • MedVadis Research Corporation

    Waltham, MA 02451

    Site contact: David DiBenedetto

  • Great Lakes Research Group, Inc.

    Bay City, MI 48706

    Site contact: Jeffrey Potts

  • StudyMetrix Research

    City of Saint Peters, MO 63303

    Site contact: Timothy Smith

  • Clinvest Research LLC

    Springfield, MO 65807

    Site contact: Ralph Duda

  • Rochester Clinical Research, LLC

    Rochester, NY 14609

    Site contact: Patrick Connors

  • Lillestol Research

    Fargo, ND 58104

    Site contact: Michael Lillestol

  • META Medical Research Institute

    Dayton, OH 45432

    Site contact: Priyesh Mehta

  • DelRicht Research

    Tulsa, OK 74133

    Site contact: Melita Tate

  • Altoona Center For Clinical Research

    Duncansville, PA 16635

    Site contact: Alan Kivitz

  • FutureSearch Trials of Neurology

    Austin, TX 78731

    Site contact: John Hudson

  • Re:Cognition Health - Fort Worth

    Fort Worth, TX 76104

    Site contact: Claudia Perez

  • Northwest Clinical Research Center

    Bellevue, WA 98007

    Site contact: Arifulla Khan, MD

  • Rainier Clinical Research Center

    Renton, WA 98057

    Site contact: Sheryl Marks

Study contacts (from the official record)

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com
  • Physicians interested in becoming principal investigators please contact · clinical_inquiry_hub@lilly.com
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A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in… (NCT07285018) | Bored Studies