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

Purpose

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.

Condition

  • Diabetic Peripheral Neuropathic Pain

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LY4065967 		Participants will receive LY4065967 orally.
  • Drug: LY4065967
    Administered orally
Placebo Comparator
Placebo 		Participants will receive placebo orally.
  • Drug: Placebo
    Administered orally

Recruiting Locations

Central Research Associates
Birmingham, Alabama 35205

Synexus Clinical Research US, Inc.
Phoenix, Arizona 85020

Arizona Research Center
Phoenix, Arizona 85053

Desert Oasis Healthcare Medical Group
Palm Springs, California 92262

Artemis Institute for Clinical Research
Riverside, California 92503

Artemis Institute for Clinical Research
San Diego, California 92123

CMR of Greater New Haven
Hamden, Connecticut 06517

Bradenton Research Center, Inc.
Bradenton, Florida 34205

Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida 32720

K2 MEDICAL Research THE VILLAGES
Lady Lake, Florida 32159

K2 Medical Research ORLANDO
Maitland, Florida 32751

Merritt Island Medical Research, LLC
Merritt Island, Florida 32952

Suncoast Research Group
Miami, Florida 33135

New Horizon Research Center
Miami, Florida 33165

Suncoast Clinical Research, Inc.
New Port Richey, Florida 34652

Renstar Medical Research
Ocala, Florida 34470

Precision Clinical Research
Sunrise, Florida 33351

Charter Research - Lady Lake
The Villages, Florida 32162

Conquest Research
Winter Park, Florida 32789

North Georgia Clinical Research
Woodstock, Georgia 30189

Northwestern University
Chicago, Illinois 60611

DelRicht Research
New Orleans, Louisiana 70115

Lucida Clinical Trials
New Bedford, Massachusetts 02740

MedVadis Research Corporation
Waltham, Massachusetts 02451

Great Lakes Research Group, Inc.
Bay City, Michigan 48706

StudyMetrix Research
City of Saint Peters, Missouri 63303

Clinvest Research LLC
Springfield, Missouri 65807

Rochester Clinical Research, LLC
Rochester, New York 14609

Lillestol Research
Fargo, North Dakota 58104

META Medical Research Institute
Dayton, Ohio 45432

DelRicht Research
Tulsa, Oklahoma 74133

Altoona Center For Clinical Research
Duncansville, Pennsylvania 16635

FutureSearch Trials of Neurology
Austin, Texas 78731

Re:Cognition Health - Fort Worth
Fort Worth, Texas 76104

Northwest Clinical Research Center
Bellevue, Washington 98007

Rainier Clinical Research Center
Renton, Washington 98057

Ponce Medical School Foundation Inc.
Ponce, Puerto Rico 00716

More Details

NCT ID
NCT07285018
Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center