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NCT07285018PHASE2Recruiting

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

Eli Lilly and Company

Start Date

2/16/2026

Completion Date

7/1/2027

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

Age Range: 18 years to No maximum

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

Interventions

DRUG

LY4065967

DRUG

Placebo

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Conditions

Diabetic Peripheral Neuropathic Pain

Locations

Central Research Associates

Birmingham, Alabama 35205

United States

Synexus Clinical Research US, Inc.

Phoenix, Arizona 85020

United States

Arizona Research Center

Phoenix, Arizona 85053

United States

Desert Oasis Healthcare Medical Group

Palm Springs, California 92262

United States

Artemis Institute for Clinical Research

Riverside, California 92503

United States

Artemis Institute for Clinical Research

San Diego, California 92123

United States

CMR of Greater New Haven

Hamden, Connecticut 06517

United States

Bradenton Research Center, Inc.

Bradenton, Florida 34205

United States

Accel Research Sites - DeLand Clinical Research Unit

DeLand, Florida 32720

United States

K2 MEDICAL Research THE VILLAGES

Lady Lake, Florida 32159

United States

K2 Medical Research ORLANDO

Maitland, Florida 32751

United States

Merritt Island Medical Research, LLC

Merritt Island, Florida 32952

United States

Suncoast Research Group

Miami, Florida 33135

United States

New Horizon Research Center

Miami, Florida 33165

United States

Suncoast Clinical Research, Inc.

New Port Richey, Florida 34652

United States

Renstar Medical Research

Ocala, Florida 34470

United States

Precision Clinical Research

Sunrise, Florida 33351

United States

Charter Research - Lady Lake

The Villages, Florida 32162

United States

Conquest Research

Winter Park, Florida 32789

United States

North Georgia Clinical Research

Woodstock, Georgia 30189

United States

Northwestern University

Chicago, Illinois 60611

United States

DelRicht Research

New Orleans, Louisiana 70115

United States

Lucida Clinical Trials

New Bedford, Massachusetts 02740

United States

MedVadis Research Corporation

Waltham, Massachusetts 02451

United States

Great Lakes Research Group, Inc.

Bay City, Michigan 48706

United States

StudyMetrix Research

City of Saint Peters, Missouri 63303

United States

Clinvest Research LLC

Springfield, Missouri 65807

United States

Rochester Clinical Research, LLC

Rochester, New York 14609

United States

Lillestol Research

Fargo, North Dakota 58104

United States

META Medical Research Institute

Dayton, Ohio 45432

United States

DelRicht Research

Tulsa, Oklahoma 74133

United States

Altoona Center For Clinical Research

Duncansville, Pennsylvania 16635

United States

FutureSearch Trials of Neurology

Austin, Texas 78731

United States

Re:Cognition Health - Fort Worth

Fort Worth, Texas 76104

United States

Northwest Clinical Research Center

Bellevue, Washington 98007

United States

Rainier Clinical Research Center

Renton, Washington 98057

United States

Ponce Medical School Foundation Inc.

Ponce, 00716

Puerto Rico