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

RecruitingPhase 2

Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY4065967 for the Treatment of Diabetic Peripheral Neuropathic Pain

Who can join

Ages 18 and older · All sexes

Full eligibility 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

About the study

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.

What is being tested

Sponsor: Eli Lilly and Company · Participants: 150 · Started: Feb 16, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07285018

Locations in the U.S.

AlabamaCentral Research Associates, Birmingham
ArizonaArizona Research Center, Phoenix
Synexus Clinical Research US, Inc., Phoenix
CaliforniaDesert Oasis Healthcare Medical Group, Palm Springs
Artemis Institute for Clinical Research, Riverside
Artemis Institute for Clinical Research, San Diego
ConnecticutCMR of Greater New Haven, Hamden
FloridaBradenton Research Center, Inc., Bradenton
Accel Research Sites - DeLand Clinical Research Unit, DeLand
K2 MEDICAL Research THE VILLAGES, Lady Lake
K2 Medical Research ORLANDO, Maitland
Merritt Island Medical Research, LLC, Merritt Island
New Horizon Research Center, Miami
Suncoast Research Group, Miami
Suncoast Clinical Research, Inc., New Port Richey
Renstar Medical Research, Ocala
Precision Clinical Research, Sunrise
Charter Research - Lady Lake, The Villages
Conquest Research, Winter Park
GeorgiaNorth Georgia Clinical Research, Woodstock
IllinoisNorthwestern University, Chicago
LouisianaDelRicht Research, New Orleans
MassachusettsLucida Clinical Trials, New Bedford
MedVadis Research Corporation, Waltham
MichiganGreat Lakes Research Group, Inc., Bay City
MissouriStudyMetrix Research, City of Saint Peters
Clinvest Research LLC, Springfield
New YorkRochester Clinical Research, LLC, Rochester
North DakotaLillestol Research, Fargo
OhioMETA Medical Research Institute, Dayton
OklahomaDelRicht Research, Tulsa
PennsylvaniaAltoona Center For Clinical Research, Duncansville
TexasFutureSearch Trials of Neurology, Austin
Re:Cognition Health - Fort Worth, Fort Worth
WashingtonNorthwest Clinical Research Center, Bellevue
Rainier Clinical Research Center, Renton

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.