Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07285018

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

Led by Eli Lilly and Company · Updated on 2026-03-27

150

Participants Needed

37

Research Sites

71 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have diabetic peripheral neuropathy affecting both lower legs for at least 6 months, diagnosed by a Michigan Neuropathy Screening Instrument score of 3 or higher
  • Have a history and current diagnosis of type 1 or type 2 diabetes mellitus
  • Have an HbA1c less than 11% and have been on a stable diabetes treatment regimen for at least 90 days before screening
  • Have a body mass index of 40 kg/m2 or less at screening
Not Eligible

You will not qualify if you...

  • Are pregnant or breastfeeding
  • Have other causes of pain that could affect self-assessment of diabetic peripheral neuropathic pain
  • Have had a lower limb amputation related to diabetes, including the great toe
  • Have low serum vitamin B12 levels (200 pg/mL or less)
  • Have high blood pressure (systolic >140 mm Hg or diastolic >90 mm Hg) at screening
  • Have a history or current significant heart disease, including arrhythmia, aortic aneurysm, heart failure, or electrolyte problems that increase arrhythmia risk according to the investigator's judgment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 37 locations

1

Central Research Associates

Birmingham, Alabama, United States, 35205

Actively Recruiting

2

Synexus Clinical Research US, Inc.

Phoenix, Arizona, United States, 85020

Actively Recruiting

3

Arizona Research Center

Phoenix, Arizona, United States, 85053

Actively Recruiting

4

Desert Oasis Healthcare Medical Group

Palm Springs, California, United States, 92262

Actively Recruiting

5

Artemis Institute for Clinical Research

Riverside, California, United States, 92503

Actively Recruiting

6

Artemis Institute for Clinical Research

San Diego, California, United States, 92123

Actively Recruiting

7

CMR of Greater New Haven

Hamden, Connecticut, United States, 06517

Actively Recruiting

8

Bradenton Research Center, Inc.

Bradenton, Florida, United States, 34205

Actively Recruiting

9

Accel Research Sites - DeLand Clinical Research Unit

DeLand, Florida, United States, 32720

Actively Recruiting

10

K2 MEDICAL Research THE VILLAGES

Lady Lake, Florida, United States, 32159

Actively Recruiting

11

K2 Medical Research ORLANDO

Maitland, Florida, United States, 32751

Actively Recruiting

12

Merritt Island Medical Research, LLC

Merritt Island, Florida, United States, 32952

Actively Recruiting

13

Suncoast Research Group

Miami, Florida, United States, 33135

Actively Recruiting

14

New Horizon Research Center

Miami, Florida, United States, 33165

Actively Recruiting

15

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States, 34652

Actively Recruiting

16

Renstar Medical Research

Ocala, Florida, United States, 34470

Actively Recruiting

17

Precision Clinical Research

Sunrise, Florida, United States, 33351

Actively Recruiting

18

Charter Research - Lady Lake

The Villages, Florida, United States, 32162

Actively Recruiting

19

Conquest Research

Winter Park, Florida, United States, 32789

Actively Recruiting

20

North Georgia Clinical Research

Woodstock, Georgia, United States, 30189

Actively Recruiting

21

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

22

DelRicht Research

New Orleans, Louisiana, United States, 70115

Actively Recruiting

23

Lucida Clinical Trials

New Bedford, Massachusetts, United States, 02740

Actively Recruiting

24

MedVadis Research Corporation

Waltham, Massachusetts, United States, 02451

Actively Recruiting

25

Great Lakes Research Group, Inc.

Bay City, Michigan, United States, 48706

Actively Recruiting

26

StudyMetrix Research

City of Saint Peters, Missouri, United States, 63303

Actively Recruiting

27

Clinvest Research LLC

Springfield, Missouri, United States, 65807

Actively Recruiting

28

Rochester Clinical Research, LLC

Rochester, New York, United States, 14609

Actively Recruiting

29

Lillestol Research

Fargo, North Dakota, United States, 58104

Actively Recruiting

30

META Medical Research Institute

Dayton, Ohio, United States, 45432

Actively Recruiting

31

DelRicht Research

Tulsa, Oklahoma, United States, 74133

Actively Recruiting

32

Altoona Center For Clinical Research

Duncansville, Pennsylvania, United States, 16635

Actively Recruiting

33

FutureSearch Trials of Neurology

Austin, Texas, United States, 78731

Actively Recruiting

34

Re:Cognition Health - Fort Worth

Fort Worth, Texas, United States, 76104

Actively Recruiting

35

Northwest Clinical Research Center

Bellevue, Washington, United States, 98007

Actively Recruiting

36

Rainier Clinical Research Center

Renton, Washington, United States, 98057

Actively Recruiting

37

Ponce Medical School Foundation Inc.

Ponce, Puerto Rico, 00716

Actively Recruiting

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Research Team

T

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

CONTACT

P

Physicians interested in becoming principal investigators please contact

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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