Recruiting
Phase 2

LY4065967

Sponsor:

Eli Lilly and Company

Code:

NCT07285018

Conditions

Diabetic Peripheral Neuropathic Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LY4065967

Placebo

Study Details

Brief 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.

Conditions

Diabetic Peripheral Neuropathic Pain

Study ID

NCT07285018

Start date

Feb 16, 2026

Status verified date

Jul, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LY4065967

Participants will receive LY4065967 orally.

placebo comparator: Placebo

Participants will receive placebo orally.

Interventions

LY4065967

Administered orally

Placebo

Administered orally

Primary outcome measure

  • Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) [ Time Frame: Baseline, Week 8 ]

Central Contacts and Locations

Central contacts

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

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

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Central Research Associates

Recruiting

Birmingham, Alabama, United States, 35205

Principal Investigator:

David DeAtkine

Synexus Clinical Research US, Inc.

Recruiting

Phoenix, Arizona, United States, 85020

Principal Investigator:

Shawn Searle

Arizona Research Center

Recruiting

Phoenix, Arizona, United States, 85053

Principal Investigator:

Louise Taber MD

Desert Oasis Healthcare Medical Group

Recruiting

Palm Springs, California, United States, 92262

Principal Investigator:

Michael Jardula

Artemis Institute for Clinical Research

Recruiting

Riverside, California, United States, 92503

Principal Investigator:

Jack Vu

Artemis Institute for Clinical Research

Recruiting

San Diego, California, United States, 92123

Principal Investigator:

Stacey Layle

CMR of Greater New Haven

Recruiting

Hamden, Connecticut, United States, 06517

Principal Investigator:

Joseph Soufer

Bradenton Research Center, Inc.

Recruiting

Bradenton, Florida, United States, 34205

Principal Investigator:

Eric Folkens

Accel Research Sites - DeLand Clinical Research Unit

Recruiting

DeLand, Florida, United States, 32720

Principal Investigator:

Bruce Rankin

K2 MEDICAL Research THE VILLAGES

Recruiting

Lady Lake, Florida, United States, 32159

Principal Investigator:

Craig Curtis

K2 Medical Research ORLANDO

Recruiting

Maitland, Florida, United States, 32751

Principal Investigator:

Brandon Lenox

Merritt Island Medical Research, LLC

Recruiting

Merritt Island, Florida, United States, 32952

Principal Investigator:

David Kirk

Suncoast Research Group

Recruiting

Miami, Florida, United States, 33135

Principal Investigator:

Mark Kutner

New Horizon Research Center

Recruiting

Miami, Florida, United States, 33165

Principal Investigator:

Lazaro Nunez

Suncoast Clinical Research, Inc.

Recruiting

New Port Richey, Florida, United States, 34652

Principal Investigator:

Cathy Barnes

Renstar Medical Research

Recruiting

Ocala, Florida, United States, 34470

Principal Investigator:

David Oliver

Precision Clinical Research

Recruiting

Sunrise, Florida, United States, 33351

Principal Investigator:

Richard Linn

Charter Research - Lady Lake

Recruiting

The Villages, Florida, United States, 32162

Principal Investigator:

Stephen Miller

Conquest Research

Recruiting

Winter Park, Florida, United States, 32789

Principal Investigator:

Anand Patel

North Georgia Clinical Research

Recruiting

Woodstock, Georgia, United States, 30189

Principal Investigator:

Bram Wieskopf

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

Thomas Schnitzer

DelRicht Research

Recruiting

New Orleans, Louisiana, United States, 70115

Principal Investigator:

Patrick Dennis

Lucida Clinical Trials

Recruiting

New Bedford, Massachusetts, United States, 02740

Principal Investigator:

David Shih

MedVadis Research Corporation

Recruiting

Waltham, Massachusetts, United States, 02451

Principal Investigator:

David DiBenedetto

Great Lakes Research Group, Inc.

Recruiting

Bay City, Michigan, United States, 48706

Principal Investigator:

Jeffrey Potts

StudyMetrix Research

Recruiting

City of Saint Peters, Missouri, United States, 63303

Principal Investigator:

Timothy Smith

Clinvest Research LLC

Recruiting

Springfield, Missouri, United States, 65807

Principal Investigator:

Ralph Duda

Rochester Clinical Research, LLC

Recruiting

Rochester, New York, United States, 14609

Principal Investigator:

Patrick Connors

Lillestol Research

Recruiting

Fargo, North Dakota, United States, 58104

Principal Investigator:

Michael Lillestol

META Medical Research Institute

Recruiting

Dayton, Ohio, United States, 45432

Principal Investigator:

Priyesh Mehta

DelRicht Research

Recruiting

Tulsa, Oklahoma, United States, 74133

Principal Investigator:

Melita Tate

Altoona Center For Clinical Research

Recruiting

Duncansville, Pennsylvania, United States, 16635

Principal Investigator:

Alan Kivitz

FutureSearch Trials of Neurology

Recruiting

Austin, Texas, United States, 78731

Principal Investigator:

John Hudson

Re:Cognition Health - Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Principal Investigator:

Claudia Perez

Northwest Clinical Research Center

Recruiting

Bellevue, Washington, United States, 98007

Principal Investigator:

Arifulla Khan, MD

Rainier Clinical Research Center

Recruiting

Renton, Washington, United States, 98057

Principal Investigator:

Sheryl Marks

More Information

Sponsor

Eli Lilly and Company

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-07-07.