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

NCT07285018 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: 27370H0P-MC-NP07H0P-MC-CPMP
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 37

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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)

  Baseline, Week 8

Secondary Outcomes (6)

• Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score

  Baseline, Week 8

• Change from Baseline in Overall Improvement as Measured by Patient's Global Impression of Change (PGI-C)

  Baseline, Week 8

• Change from Baseline in Worst Pain Intensity as Measured by NRS

  Baseline, Week 8

• Change from Baseline in Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale)

  Baseline, Week 8

• Change from Baseline in Emotional Functioning as Measured by the EuroQol-5D 5 Level Questionnaire (EQ 5D 5L)

  Baseline, Week 8

Study Arms (2)

LY4065967

EXPERIMENTAL

Participants will receive LY4065967 orally.

Drug: LY4065967

Placebo

PLACEBO COMPARATOR

Participants will receive placebo orally.

Drug: Placebo

Interventions

LY4065967 DRUG

Administered orally

LY4065967

Placebo DRUG

Administered orally

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (37)

Central Research Associates

Birmingham, Alabama, 35205, United States

RECRUITING

Synexus Clinical Research US, Inc.

Phoenix, Arizona, 85020, United States

RECRUITING

Arizona Research Center

Phoenix, Arizona, 85053, United States

RECRUITING

Desert Oasis Healthcare Medical Group

Palm Springs, California, 92262, United States

RECRUITING

Artemis Institute for Clinical Research

Riverside, California, 92503, United States

RECRUITING

Artemis Institute for Clinical Research

San Diego, California, 92123, United States

RECRUITING

CMR of Greater New Haven

Hamden, Connecticut, 06517, United States

RECRUITING

Bradenton Research Center, Inc.

Bradenton, Florida, 34205, United States

RECRUITING

Accel Research Sites - DeLand Clinical Research Unit

DeLand, Florida, 32720, United States

RECRUITING

K2 MEDICAL Research THE VILLAGES

Lady Lake, Florida, 32159, United States

RECRUITING

K2 Medical Research ORLANDO

Maitland, Florida, 32751, United States

RECRUITING

Merritt Island Medical Research, LLC

Merritt Island, Florida, 32952, United States

RECRUITING

Suncoast Research Group

Miami, Florida, 33135, United States

RECRUITING

New Horizon Research Center

Miami, Florida, 33165, United States

RECRUITING

Suncoast Clinical Research, Inc.

New Port Richey, Florida, 34652, United States

RECRUITING

Renstar Medical Research

Ocala, Florida, 34470, United States

RECRUITING

Precision Clinical Research

Sunrise, Florida, 33351, United States

RECRUITING

Charter Research - Lady Lake

The Villages, Florida, 32162, United States

RECRUITING

Conquest Research

Winter Park, Florida, 32789, United States

RECRUITING

North Georgia Clinical Research

Woodstock, Georgia, 30189, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

DelRicht Research

New Orleans, Louisiana, 70115, United States

RECRUITING

Lucida Clinical Trials

New Bedford, Massachusetts, 02740, United States

RECRUITING

MedVadis Research Corporation

Waltham, Massachusetts, 02451, United States

RECRUITING

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706, United States

RECRUITING

StudyMetrix Research

City of Saint Peters, Missouri, 63303, United States

RECRUITING

Clinvest Research LLC

Springfield, Missouri, 65807, United States

RECRUITING

Rochester Clinical Research, LLC

Rochester, New York, 14609, United States

RECRUITING

Lillestol Research

Fargo, North Dakota, 58104, United States

RECRUITING

META Medical Research Institute

Dayton, Ohio, 45432, United States

RECRUITING

DelRicht Research

Tulsa, Oklahoma, 74133, United States

RECRUITING

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635, United States

RECRUITING

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

RECRUITING

Re:Cognition Health - Fort Worth

Fort Worth, Texas, 76104, United States

RECRUITING

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

RECRUITING

Rainier Clinical Research Center

Renton, Washington, 98057, United States

RECRUITING

Ponce Medical School Foundation Inc.

Ponce, 00716, Puerto Rico

RECRUITING

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 16, 2025
• Study Start: February 16, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

US (36); PR (1)