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A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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

NCT07285018•Eli Lilly and Company

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (37)

Central Research Associates

Birmingham, Alabama, United States

Synexus Clinical Research US, Inc.

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

Key Dates

Start Date

February 16, 2026

Primary Completion Date

July 1, 2027

Completion Date

July 1, 2027

Last Updated

February 27, 2026

Enrollment

150

ESTIMATED participants

Conditions

Diabetic Peripheral Neuropathic Pain

Interventions

LY4065967

DRUG

Placebo

DRUG

Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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