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New hope for diabetic nerve pain: experimental drug enters phase 2 trial

NCT ID NCT07285018

Symptom relief Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This study tests whether a new drug called LY4065967 can safely reduce nerve pain in people with diabetes. About 150 adults with diabetic nerve pain in their legs for at least 6 months will receive either the study drug or a placebo. The main goal is to see if the drug lowers average pain levels over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diabetic neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic peripheral neuropathic pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    37 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Accel Research Sites - DeLand Clinical Research Unit

    RECRUITING

    DeLand, Florida, 32720, United States

  • Altoona Center For Clinical Research

    RECRUITING

    Duncansville, Pennsylvania, 16635, United States

  • Arizona Research Center

    RECRUITING

    Phoenix, Arizona, 85053, United States

  • Artemis Institute for Clinical Research

    RECRUITING

    Riverside, California, 92503, United States

  • Artemis Institute for Clinical Research

    RECRUITING

    San Diego, California, 92123, United States

  • Bradenton Research Center, Inc.

    RECRUITING

    Bradenton, Florida, 34205, United States

  • CMR of Greater New Haven

    RECRUITING

    Hamden, Connecticut, 06517, United States

  • Central Research Associates

    RECRUITING

    Birmingham, Alabama, 35205, United States

  • Charter Research - Lady Lake

    RECRUITING

    The Villages, Florida, 32162, United States

  • Clinvest Research LLC

    RECRUITING

    Springfield, Missouri, 65807, United States

  • Conquest Research

    RECRUITING

    Winter Park, Florida, 32789, United States

  • DelRicht Research

    RECRUITING

    New Orleans, Louisiana, 70115, United States

  • DelRicht Research

    RECRUITING

    Tulsa, Oklahoma, 74133, United States

  • Desert Oasis Healthcare Medical Group

    RECRUITING

    Palm Springs, California, 92262, United States

  • FutureSearch Trials of Neurology

    RECRUITING

    Austin, Texas, 78731, United States

  • Great Lakes Research Group, Inc.

    RECRUITING

    Bay City, Michigan, 48706, United States

  • K2 MEDICAL Research THE VILLAGES

    RECRUITING

    Lady Lake, Florida, 32159, United States

  • K2 Medical Research ORLANDO

    RECRUITING

    Maitland, Florida, 32751, United States

  • Lillestol Research

    RECRUITING

    Fargo, North Dakota, 58104, United States

  • Lucida Clinical Trials

    RECRUITING

    New Bedford, Massachusetts, 02740, United States

  • META Medical Research Institute

    RECRUITING

    Dayton, Ohio, 45432, United States

  • MedVadis Research Corporation

    RECRUITING

    Waltham, Massachusetts, 02451, United States

  • Merritt Island Medical Research, LLC

    RECRUITING

    Merritt Island, Florida, 32952, United States

  • New Horizon Research Center

    RECRUITING

    Miami, Florida, 33165, United States

  • North Georgia Clinical Research

    RECRUITING

    Woodstock, Georgia, 30189, United States

  • Northwest Clinical Research Center

    RECRUITING

    Bellevue, Washington, 98007, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Ponce Medical School Foundation Inc.

    RECRUITING

    Ponce, 00716, Puerto Rico

  • Precision Clinical Research

    RECRUITING

    Sunrise, Florida, 33351, United States

  • Rainier Clinical Research Center

    RECRUITING

    Renton, Washington, 98057, United States

  • Re:Cognition Health - Fort Worth

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Renstar Medical Research

    RECRUITING

    Ocala, Florida, 34470, United States

  • Rochester Clinical Research, LLC

    RECRUITING

    Rochester, New York, 14609, United States

  • StudyMetrix Research

    RECRUITING

    City of Saint Peters, Missouri, 63303, United States

  • Suncoast Clinical Research, Inc.

    RECRUITING

    New Port Richey, Florida, 34652, United States

  • Suncoast Research Group

    RECRUITING

    Miami, Florida, 33135, United States

  • Synexus Clinical Research US, Inc.

    RECRUITING

    Phoenix, Arizona, 85020, United States

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