Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY4065967 for the Treatment of Diabetic Peripheral Neuropathic Pain Status: Recruiting
Location: See all (37) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Participation Requirements View:
Inclusion Criteria
Exclusion 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)
Central Research Associates
RECRUITING
Birmingham
Arizona Research Center
RECRUITING
Phoenix
Synexus Clinical Research US, Inc.
RECRUITING
Phoenix
Desert Oasis Healthcare Medical Group
RECRUITING
Palm Springs
Artemis Institute for Clinical Research
RECRUITING
Riverside
Artemis Institute for Clinical Research
RECRUITING
San Diego
CMR of Greater New Haven
RECRUITING
Hamden
Bradenton Research Center, Inc.
RECRUITING
Bradenton
Accel Research Sites - DeLand Clinical Research Unit
RECRUITING
Deland
K2 MEDICAL Research THE VILLAGES
RECRUITING
Lady Lake
K2 Medical Research ORLANDO
RECRUITING
Maitland
Merritt Island Medical Research, LLC
RECRUITING
Merritt Island
New Horizon Research Center
RECRUITING
Miami
Suncoast Research Group
RECRUITING
Miami
Suncoast Clinical Research, Inc.
RECRUITING
New Port Richey
Renstar Medical Research
RECRUITING
Ocala
Precision Clinical Research
RECRUITING
Sunrise
Charter Research - Lady Lake
RECRUITING
The Villages
Conquest Research
RECRUITING
Winter Park
North Georgia Clinical Research
RECRUITING
Woodstock
Northwestern University
RECRUITING
Chicago
DelRicht Research
RECRUITING
New Orleans
Lucida Clinical Trials
RECRUITING
New Bedford
MedVadis Research Corporation
RECRUITING
Waltham
Great Lakes Research Group, Inc.
RECRUITING
Bay City
StudyMetrix Research
RECRUITING
City Of Saint Peters
Clinvest Research LLC
RECRUITING
Springfield
Lillestol Research
RECRUITING
Fargo
Rochester Clinical Research, LLC
RECRUITING
Rochester
META Medical Research Institute
RECRUITING
Dayton
DelRicht Research
RECRUITING
Tulsa
Altoona Center For Clinical Research
RECRUITING
Duncansville
FutureSearch Trials of Neurology
RECRUITING
Austin
Re:Cognition Health - Fort Worth
RECRUITING
Fort Worth
Northwest Clinical Research Center
RECRUITING
Bellevue
Rainier Clinical Research Center
RECRUITING
Renton
Ponce Medical School Foundation Inc.
RECRUITING
Ponce
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Start Date: 2026-02-16
Estimated Completion Date: 2027-07
Target number of participants: 150
Experimental: LY4065967
Participants will receive LY4065967 orally.
Placebo_comparator: Placebo
Participants will receive placebo orally.
Leads: Eli Lilly and Company