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Clinical Trials in the USA / NCT07285018
Recruiting Phase 2

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

NCT07285018 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 2
Started
2026-02-16
Last updated
2026-07-07

Condition(s) studied

Diabetic Peripheral Neuropathic Pain

Investigational drug(s) / intervention(s)

LY4065967Placebo

LY4065967: Administered orally

Placebo: Administered orally

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

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

Trial sites (37)

FacilityCityRegionStatus
Central Research Associates Birmingham Alabama Recruiting
Synexus Clinical Research US, Inc. Phoenix Arizona Recruiting
Arizona Research Center Phoenix Arizona Recruiting
Desert Oasis Healthcare Medical Group Palm Springs California Recruiting
Artemis Institute for Clinical Research Riverside California Recruiting
Artemis Institute for Clinical Research San Diego California Recruiting
CMR of Greater New Haven Hamden Connecticut Recruiting
Bradenton Research Center, Inc. Bradenton Florida Recruiting
Accel Research Sites - DeLand Clinical Research Unit DeLand Florida Recruiting
K2 MEDICAL Research THE VILLAGES Lady Lake Florida Recruiting
K2 Medical Research ORLANDO Maitland Florida Recruiting
Merritt Island Medical Research, LLC Merritt Island Florida Recruiting
Suncoast Research Group Miami Florida Recruiting
New Horizon Research Center Miami Florida Recruiting
Suncoast Clinical Research, Inc. New Port Richey Florida Recruiting
Renstar Medical Research Ocala Florida Recruiting
Precision Clinical Research Sunrise Florida Recruiting
Charter Research - Lady Lake The Villages Florida Recruiting
Conquest Research Winter Park Florida Recruiting
North Georgia Clinical Research Woodstock Georgia Recruiting
Northwestern University Chicago Illinois Recruiting
DelRicht Research New Orleans Louisiana Recruiting
Lucida Clinical Trials New Bedford Massachusetts Recruiting
MedVadis Research Corporation Waltham Massachusetts Recruiting
Great Lakes Research Group, Inc. Bay City Michigan Recruiting
StudyMetrix Research City of Saint Peters Missouri Recruiting
Clinvest Research LLC Springfield Missouri Recruiting
Rochester Clinical Research, LLC Rochester New York Recruiting
Lillestol Research Fargo North Dakota Recruiting
META Medical Research Institute Dayton Ohio Recruiting
DelRicht Research Tulsa Oklahoma Recruiting
Altoona Center For Clinical Research Duncansville Pennsylvania Recruiting
FutureSearch Trials of Neurology Austin Texas Recruiting
Re:Cognition Health - Fort Worth Fort Worth Texas Recruiting
Northwest Clinical Research Center Bellevue Washington Recruiting
Rainier Clinical Research Center Renton Washington Recruiting
Ponce Medical School Foundation Inc. Ponce Puerto Rico Recruiting

More Eli Lilly and Company trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07285018 on ClinicalTrials.gov ↗ ← All trials in the USA