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

March 26, 2026 updated by: Eli Lilly and Company

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
Time Frame: Baseline, Week 8
Baseline, Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score
Time Frame: Baseline, Week 8
Baseline, Week 8
Change from Baseline in Overall Improvement as Measured by Patient's Global Impression of Change (PGI-C)
Time Frame: Baseline, Week 8
Baseline, Week 8
Change from Baseline in Worst Pain Intensity as Measured by NRS
Time Frame: Baseline, Week 8
Baseline, Week 8
Change from Baseline in Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale)
Time Frame: Baseline, Week 8
Baseline, Week 8
Change from Baseline in Emotional Functioning as Measured by the EuroQol-5D 5 Level Questionnaire (EQ 5D 5L)
Time Frame: Baseline, Week 8
Baseline, Week 8
Total Amount of Rescue Medication Used Daily During the Treatment Phase
Time Frame: Week 8
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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