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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Diabetic Peripheral Neuropathic Pain

In brief

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.

Key facts

Study ID

NCT07285018

Run by

Eli Lilly and Company

People needed

150

Starts

2026-02-16

Expected to finish

2027-07-01

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Central Research Associates — Birmingham, Alabama, United States (enrolling)
• Synexus Clinical Research US, Inc. — Phoenix, Arizona, United States (enrolling)
• Arizona Research Center — Phoenix, Arizona, United States (enrolling)
• Desert Oasis Healthcare Medical Group — Palm Springs, California, United States (enrolling)
• Artemis Institute for Clinical Research — Riverside, California, United States (enrolling)
• Artemis Institute for Clinical Research — San Diego, California, United States (enrolling)
• CMR of Greater New Haven — Hamden, Connecticut, United States (enrolling)
• Bradenton Research Center, Inc. — Bradenton, Florida, United States (enrolling)
• Accel Research Sites - DeLand Clinical Research Unit — DeLand, Florida, United States (enrolling)
• K2 MEDICAL Research THE VILLAGES — Lady Lake, Florida, United States (enrolling)
• K2 Medical Research ORLANDO — Maitland, Florida, United States (enrolling)
• Merritt Island Medical Research, LLC — Merritt Island, Florida, United States (enrolling)
• Suncoast Research Group — Miami, Florida, United States (enrolling)
• New Horizon Research Center — Miami, Florida, United States (enrolling)
• Suncoast Clinical Research, Inc. — New Port Richey, Florida, United States (enrolling)
• Renstar Medical Research — Ocala, Florida, United States (enrolling)
• Precision Clinical Research — Sunrise, Florida, United States (enrolling)
• Charter Research - Lady Lake — The Villages, Florida, United States (enrolling)
• Conquest Research — Winter Park, Florida, United States (enrolling)
• North Georgia Clinical Research — Woodstock, Georgia, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• DelRicht Research — New Orleans, Louisiana, United States (enrolling)
• Lucida Clinical Trials — New Bedford, Massachusetts, United States (enrolling)
• MedVadis Research Corporation — Waltham, Massachusetts, United States (enrolling)
• Great Lakes Research Group, Inc. — Bay City, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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