A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
NCT ID: NCT07285018
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2025-12-18
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LY4065967
Participants will receive LY4065967 orally.
LY4065967
Administered orally
Placebo
Participants will receive placebo orally.
Placebo
Administered orally
Interventions
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LY4065967
Administered orally
Placebo
Administered orally
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Central Research Associates
Birmingham, Alabama, United States
Central Phoenix Medical Clinic
Phoenix, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Desert Oasis Healthcare Medical Group
Palm Springs, California, United States
Artemis Institute for Clinical Research
Riverside, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
CMR of Greater New Haven
Hamden, Connecticut, United States
Bradenton Research Center, Inc.
Bradenton, Florida, United States
Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, United States
K2 MEDICAL Research THE VILLAGES
Lady Lake, Florida, United States
K2 Medical Research ORLANDO
Maitland, Florida, United States
Merritt Island Medical Research, LLC
Merritt Island, Florida, United States
Suncoast Research Group
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Precision Clinical Research
Sunrise, Florida, United States
Charter Research - Lady Lake
The Villages, Florida, United States
Conquest Research
Winter Park, Florida, United States
North Georgia Clinical Research
Woodstock, Georgia, United States
Northwestern University
Chicago, Illinois, United States
DelRicht Research
New Orleans, Louisiana, United States
Lucida Clinical Trials
New Bedford, Massachusetts, United States
MedVadis Research Corporation
Waltham, Massachusetts, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
StudyMetrix Research
City of Saint Peters, Missouri, United States
Clinvest Research LLC
Springfield, Missouri, United States
Rochester Clinical Research, LLC
Rochester, New York, United States
Lillestol Research
Fargo, North Dakota, United States
META Medical Research Institute
Dayton, Ohio, United States
DelRicht Research
Tulsa, Oklahoma, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
Re:Cognition Health - Fort Worth
Fort Worth, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Rainier Clinical Research Center
Renton, Washington, United States
Ponce Medical School Foundation Inc.
Ponce, , Puerto Rico
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Other Identifiers
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H0P-MC-NP07
Identifier Type: OTHER
Identifier Source: secondary_id
H0P-MC-CPMP
Identifier Type: OTHER
Identifier Source: secondary_id
27370
Identifier Type: -
Identifier Source: org_study_id
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