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NCT Number: NCT07285018

A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ponce Medical School Foundation Inc., Ponce, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY4065967

Drug

Administered orally

Placebo

Drug

Administered orally

Primary outcomes

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

    Time frame: Baseline, Week 8

Secondary outcomes

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

    Time frame: Baseline, Week 8

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

    Time frame: Baseline, Week 8

  3. Change from Baseline in Worst Pain Intensity as Measured by NRS

    Time frame: Baseline, Week 8

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

    Time frame: Baseline, Week 8

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

    Time frame: Baseline, Week 8

  6. Total Amount of Rescue Medication Used Daily During the Treatment Phase

    Time frame: Week 8

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

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

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Acronym: NP07

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 16, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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