A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain (NP07)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Peripheral Neuropathic Pain
• Intervention / Treatment: Drug: Placebo; Drug: LY4065967

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: LillyTrials@Lilly.com
• Study Contact Backup: Name: Physicians interested in becoming principal investigators please contact; Email: clinical_inquiry_hub@lilly.com

Study Locations

• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • Recruiting
    • Ponce Medical School Foundation Inc.
    • Principal Investigator: Elizabeth Barranco-Santana
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Recruiting
      • Central Research Associates
      • Principal Investigator: David DeAtkine
  • Arizona
    • Phoenix, Arizona, United States, 85053
      • Recruiting
      • Arizona Research Center
      • Principal Investigator: Louise Taber MD
    • Phoenix, Arizona, United States, 85020
      • Recruiting
      • Synexus Clinical Research US, Inc.
      • Principal Investigator: Jeffrey Zacher
  • California
    • Palm Springs, California, United States, 92262
      • Recruiting
      • Desert Oasis Healthcare Medical Group
      • Principal Investigator: Michael Jardula
    • Riverside, California, United States, 92503
      • Recruiting
      • Artemis Institute for Clinical Research
      • Principal Investigator: Jack Vu
    • San Diego, California, United States, 92123
      • Recruiting
      • Artemis Institute for Clinical Research
      • Principal Investigator: Stacey Layle
  • Connecticut
    • Hamden, Connecticut, United States, 06517
      • Recruiting
      • CMR of Greater New Haven
      • Principal Investigator: Joseph Soufer
  • Florida
    • Bradenton, Florida, United States, 34205
      • Recruiting
      • Bradenton Research Center, Inc.
      • Principal Investigator: Eric Folkens
    • DeLand, Florida, United States, 32720
      • Recruiting
      • Accel Research Sites - Deland Clinical Research Unit
      • Principal Investigator: Bruce Rankin
    • Lady Lake, Florida, United States, 32159
      • Recruiting
      • K2 MEDICAL Research THE VILLAGES
      • Principal Investigator: Craig Curtis
    • Maitland, Florida, United States, 32751
      • Recruiting
      • K2 Medical Research ORLANDO
      • Principal Investigator: Brandon Lenox
    • Merritt Island, Florida, United States, 32952
      • Recruiting
      • Merritt Island Medical Research, LLC
      • Principal Investigator: David Kirk
    • Miami, Florida, United States, 33135
      • Recruiting
      • Suncoast Research Group
      • Principal Investigator: Mark Kutner
    • Miami, Florida, United States, 33165
      • Recruiting
      • New Horizon Research Center
      • Principal Investigator: Lazaro Nunez
    • New Port Richey, Florida, United States, 34652
      • Recruiting
      • Suncoast Clinical Research, Inc.
      • Principal Investigator: Cathy Barnes
    • Ocala, Florida, United States, 34470
      • Recruiting
      • Renstar Medical Research
      • Principal Investigator: David Oliver
    • Sunrise, Florida, United States, 33351
      • Recruiting
      • Precision Clinical Research
      • Principal Investigator: Richard Linn
    • The Villages, Florida, United States, 32162
      • Recruiting
      • Charter Research - Lady Lake
      • Principal Investigator: Stephen Miller
    • Winter Park, Florida, United States, 32789
      • Recruiting
      • Conquest Research
      • Principal Investigator: Anand Patel
  • Georgia
    • Woodstock, Georgia, United States, 30189
      • Recruiting
      • North Georgia Clinical Research
      • Principal Investigator: Bram Wieskopf
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Principal Investigator: Thomas Schnitzer
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Recruiting
      • Delricht Research
      • Principal Investigator: Patrick Dennis
  • Massachusetts
    • New Bedford, Massachusetts, United States, 02740
      • Recruiting
      • Lucida Clinical Trials
      • Principal Investigator: David Shih
    • Waltham, Massachusetts, United States, 02451
      • Recruiting
      • MedVadis Research Corporation
      • Principal Investigator: David DiBenedetto
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Recruiting
      • Great Lakes Research Group, Inc.
      • Principal Investigator: Jeffrey Potts
  • Missouri
    • City of Saint Peters, Missouri, United States, 63303
      • Recruiting
      • StudyMetrix Research
      • Principal Investigator: Timothy Smith
    • Springfield, Missouri, United States, 65807
      • Recruiting
      • Clinvest Research LLC
      • Principal Investigator: Ralph Duda
  • New York
    • Rochester, New York, United States, 14609
      • Recruiting
      • Rochester Clinical Research, LLC
      • Principal Investigator: Patrick Connors
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Recruiting
      • Lillestol Research
      • Principal Investigator: Michael Lillestol
  • Ohio
    • Dayton, Ohio, United States, 45432
      • Recruiting
      • META Medical Research Institute
      • Principal Investigator: Priyesh Mehta
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
      • Recruiting
      • Delricht Research
      • Principal Investigator: Melita Tate
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Recruiting
      • Altoona Center For Clinical Research
      • Principal Investigator: Alan Kivitz
  • Texas
    • Austin, Texas, United States, 78731
      • Recruiting
      • FutureSearch Trials of Neurology
      • Principal Investigator: John Hudson
    • Fort Worth, Texas, United States, 76104
      • Recruiting
      • Re:Cognition Health - Fort Worth
      • Principal Investigator: Claudia Perez
  • Washington
    • Bellevue, Washington, United States, 98007
      • Recruiting
      • Northwest Clinical Research Center
      • Principal Investigator: Arifulla Khan, MD
    • Renton, Washington, United States, 98057
      • Recruiting
      • Rainier Clinical Research Center
      • Principal Investigator: Sheryl Marks

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will receive placebo orally.	Drug: Placebo; Administered orally
Experimental: LY4065967; Participants will receive LY4065967 orally.	Drug: LY4065967; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)	Baseline, Week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Total Amount of Rescue Medication Used Daily During the Treatment Phase	Week 8

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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 record dates

Study Major Dates

• Study Start (Actual): February 16, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 27370; H0P-MC-CPMP (Other Identifier: Eli Lilly and Company); H0P-MC-NP07 (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing 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.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No