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Clinical Trials/NCT07285018
NCT07285018
Recruiting
Phase 2

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

Eli Lilly and Company37 sites in 2 countries150 target enrollmentStarted: February 16, 2026Last updated:
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InterventionsLY4065967Placebo

Overview

Phase
Phase 2
Status
Recruiting
Enrollment
150
Locations
37
Primary Endpoint
Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

LY4065967

Experimental

Participants will receive LY4065967 orally.

Intervention: LY4065967 (Drug)

Placebo

Placebo Comparator

Participants will receive placebo orally.

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

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

Time Frame: Baseline, Week 8

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (37)

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