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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-18

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Peripheral Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY4065967

Participants will receive LY4065967 orally.

Group Type EXPERIMENTAL

LY4065967

Intervention Type DRUG

Administered orally

Placebo

Participants will receive placebo orally.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Interventions

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LY4065967

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status NOT_YET_RECRUITING

Central Phoenix Medical Clinic

Phoenix, Arizona, United States

Site Status NOT_YET_RECRUITING

Arizona Research Center

Phoenix, Arizona, United States

Site Status NOT_YET_RECRUITING

Desert Oasis Healthcare Medical Group

Palm Springs, California, United States

Site Status NOT_YET_RECRUITING

Artemis Institute for Clinical Research

Riverside, California, United States

Site Status RECRUITING

Artemis Institute for Clinical Research

San Diego, California, United States

Site Status NOT_YET_RECRUITING

CMR of Greater New Haven

Hamden, Connecticut, United States

Site Status RECRUITING

Bradenton Research Center, Inc.

Bradenton, Florida, United States

Site Status NOT_YET_RECRUITING

Accel Research Sites - DeLand Clinical Research Unit

DeLand, Florida, United States

Site Status NOT_YET_RECRUITING

K2 MEDICAL Research THE VILLAGES

Lady Lake, Florida, United States

Site Status NOT_YET_RECRUITING

K2 Medical Research ORLANDO

Maitland, Florida, United States

Site Status NOT_YET_RECRUITING

Merritt Island Medical Research, LLC

Merritt Island, Florida, United States

Site Status NOT_YET_RECRUITING

Suncoast Research Group

Miami, Florida, United States

Site Status NOT_YET_RECRUITING

New Horizon Research Center

Miami, Florida, United States

Site Status RECRUITING

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States

Site Status NOT_YET_RECRUITING

Renstar Medical Research

Ocala, Florida, United States

Site Status NOT_YET_RECRUITING

Precision Clinical Research

Sunrise, Florida, United States

Site Status NOT_YET_RECRUITING

Charter Research - Lady Lake

The Villages, Florida, United States

Site Status RECRUITING

Conquest Research

Winter Park, Florida, United States

Site Status NOT_YET_RECRUITING

North Georgia Clinical Research

Woodstock, Georgia, United States

Site Status NOT_YET_RECRUITING

Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

DelRicht Research

New Orleans, Louisiana, United States

Site Status NOT_YET_RECRUITING

Lucida Clinical Trials

New Bedford, Massachusetts, United States

Site Status NOT_YET_RECRUITING

MedVadis Research Corporation

Waltham, Massachusetts, United States

Site Status NOT_YET_RECRUITING

Great Lakes Research Group, Inc.

Bay City, Michigan, United States

Site Status NOT_YET_RECRUITING

StudyMetrix Research

City of Saint Peters, Missouri, United States

Site Status RECRUITING

Clinvest Research LLC

Springfield, Missouri, United States

Site Status RECRUITING

Rochester Clinical Research, LLC

Rochester, New York, United States

Site Status NOT_YET_RECRUITING

Lillestol Research

Fargo, North Dakota, United States

Site Status RECRUITING

META Medical Research Institute

Dayton, Ohio, United States

Site Status NOT_YET_RECRUITING

DelRicht Research

Tulsa, Oklahoma, United States

Site Status NOT_YET_RECRUITING

Altoona Center For Clinical Research

Duncansville, Pennsylvania, United States

Site Status RECRUITING

FutureSearch Trials of Neurology

Austin, Texas, United States

Site Status RECRUITING

Re:Cognition Health - Fort Worth

Fort Worth, Texas, United States

Site Status NOT_YET_RECRUITING

Northwest Clinical Research Center

Bellevue, Washington, United States

Site Status RECRUITING

Rainier Clinical Research Center

Renton, Washington, United States

Site Status NOT_YET_RECRUITING

Ponce Medical School Foundation Inc.

Ponce, , Puerto Rico

Site Status NOT_YET_RECRUITING

Countries

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United States Puerto Rico

Central Contacts

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

Role: CONTACT

1-317-615-4559

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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