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New hope for diabetic nerve pain: phase 3 trial launches

NCT ID NCT06628908

Symptom relief Sponsor: Vertex Pharmaceuticals Incorporated 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a new medicine called suzetrigine for people with nerve pain from diabetes. About 1,100 adults with diabetic peripheral neuropathy will receive either suzetrigine, a placebo, or an active comparator to see if it safely reduces pain over 12 weeks. The goal is to find a better treatment option for this common and painful condition.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,100 people

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

Started

Oct 2024

Expected to finish

May 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 to 80 years

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.

Key Inclusion Criteria: * Body weight greater than or equal to (≥) 45 kilogram (kg) * Body mass index (BMI) ≥18.0 to less than (\<) 40.0 kilogram per meter square (kg/m\^2) * Diagnosis of diabetes mellitus type 1 or type 2 by glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pain in lower extremities due to DPN * Weekly average of daily NPRS score ≥4 and less than or equal to (≤) 9 with limited variation in the 7-day Baseline Period Key Exclusion Criteria: * More than 3 missing daily NPRS scores during the 7-day Baseline Period * Any sensory abnormality (excluding DPN) as pre-specified in the protocol Other protocol defined Inclusion/Exclusion criteria may apply.

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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

    59 sites. 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

  • 3Sync Research - Miami Lakes

    RECRUITING

    Miami Lakes, Florida, 33014, United States

  • AMR Daphne, AL

    COMPLETED

    Daphne, Alabama, 36526, United States

  • AMR Fort Myers (The Clinical Study Center)

    RECRUITING

    Fort Myers, Florida, 33912, United States

  • AMR Kansas City

    RECRUITING

    Kansas City, Missouri, 64114, United States

  • AMR Lexington

    RECRUITING

    Lexington, Kentucky, 40509, United States

  • AMR Nashville, TN

    COMPLETED

    Nashville, Tennessee, 37203, United States

  • AMR Wichita East, KS (Heartland Research Associates)

    RECRUITING

    Wichita, Kansas, 67207, United States

  • AMR-Miami

    RECRUITING

    Doral, Florida, 33172, United States

  • Accel Research - Decatur

    RECRUITING

    Decatur, Georgia, 30030, United States

  • Accel Research - Deland

    RECRUITING

    DeLand, Florida, 32720, United States

  • Accel Research - Maitland

    COMPLETED

    Maitland, Florida, 32751, United States

  • Accel Research - St. Petersburg-Largo

    RECRUITING

    Largo, Florida, 33777, United States

  • Albany Medical College

    COMPLETED

    Albany, New York, 12208, United States

  • Angel City Research, Inc

    RECRUITING

    Los Angeles, California, 90010, United States

  • Be Well Clinical Studies - Austin

    RECRUITING

    Round Rock, Texas, 78681, United States

  • CNS Healthcare - Jacksonville

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Carolinas Pain Institute - Winston-Salem Office

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • Clinical Trials Research

    RECRUITING

    Sacramento, California, 95821, United States

  • Clinical Trials of South Carolina - Berkeley - Charleston

    RECRUITING

    Charleston, South Carolina, 29406, United States

  • Columbia Presbyterian - The Neurological Institute of New York

    RECRUITING

    New York, New York, 10032, United States

  • Conquest Clinical Research - Orlando - Neuro

    RECRUITING

    Orlando, Florida, 32832, United States

  • Conquest Clinical Research - Winter Park

    RECRUITING

    Winter Park, Florida, 32789, United States

  • Diablo Clinical Research (DCR)

    COMPLETED

    Walnut Creek, California, 94598, United States

  • Dominion Medical Associates, Inc.

    RECRUITING

    Richmond, Virginia, 23219, United States

  • Empire Clinical Research

    RECRUITING

    Pomona, California, 91767, United States

  • Eximia Research - Raleigh

    RECRUITING

    Raleigh, North Carolina, 27607, United States

  • Feinberg School of Medicine - Anesthesiology

    RECRUITING

    Chicago, Illinois, 60611, United States

  • HRI - Hassman Research Institute

    COMPLETED

    Marlton, New Jersey, 08053, United States

  • Healthcare Research Network - Flossmoor IL

    RECRUITING

    Flossmoor, Illinois, 604773027, United States

  • Healthcare Research Network - Hazelwood MO

    RECRUITING

    Hazelwood, Missouri, 63042, United States

  • Kalo Clinical Research - West Valley City

    RECRUITING

    West Valley City, Utah, 84120, United States

  • Long Beach Research Institute

    RECRUITING

    Long Beach, California, 90805, United States

  • M3 Wake Research - Charleston

    RECRUITING

    Charleston, South Carolina, 29414, United States

  • META Medical Research Institute

    RECRUITING

    Dayton, Ohio, 45432, United States

  • Mass General Brigham - Brigham and Women's Hospital - Main Campus

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • MedVadis Research Corporation

    RECRUITING

    Waltham, Massachusetts, 02451, United States

  • Neuro-Pain Medical Center

    RECRUITING

    Fresno, California, 93710, United States

  • Northwest Clinical Research Center (NWCRC)

    RECRUITING

    Bellevue, Washington, 98007, United States

  • Pinnacle Research Group, LLC

    RECRUITING

    Anniston, Alabama, 36207, United States

  • SCLA Management - Pain Management and Injury Relief

    RECRUITING

    Thousand Oaks, California, 91320, United States

  • San Antonio Clinical Trials

    RECRUITING

    San Antonio, Texas, 78240, United States

  • Scottsdale Clinical Trials

    RECRUITING

    Scottsdale, Arizona, 85260, United States

  • St. Louis Children's Hospital - Nephrology

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Suburban Research Associates - Media

    RECRUITING

    Media, Pennsylvania, 19063, United States

  • Suncoast Clinical Research - New Port Richey

    RECRUITING

    New Port Richey, Florida, 34652, United States

  • Suncoast Research Associates - Miami

    RECRUITING

    Miami, Florida, 33172, United States

  • Swift Clinical OpCo, Inc

    RECRUITING

    Brooklyn, New York, 11226, United States

  • Synexus Clinical Research - Birmingham

    COMPLETED

    Birmingham, Alabama, 35211, United States

  • Synexus Clinical Research - Cincinnati

    COMPLETED

    Cincinnati, Ohio, 45236, United States

  • Synexus Clinical Research - Dallas (DFW) (DRS)

    COMPLETED

    Dallas, Texas, 75234, United States

  • Synexus Clinical Research - Evansville

    COMPLETED

    Evansville, Indiana, 47714, United States

  • Synexus Clinical Research - Las Vegas

    COMPLETED

    Las Vegas, Nevada, 89113, United States

  • Synexus Clinical Research - New York (DRS)

    COMPLETED

    New York, New York, 10017, United States

  • Synexus Clinical Research - Orlando

    COMPLETED

    Orlando, Florida, 32806, United States

  • Synexus Clinical Research - Phoenix Central

    COMPLETED

    Phoenix, Arizona, 85020, United States

  • Synexus Clinical Research - St. Louis

    COMPLETED

    St Louis, Missouri, 63141, United States

  • Synexus Clinical Research- Anderson

    COMPLETED

    Anderson, South Carolina, 29621, United States

  • Tandem Clinical Research- Covington

    RECRUITING

    Covington, Louisiana, 70433, United States

  • Velocity Clinical Research - Albuquerque

    RECRUITING

    Albuquerque, New Mexico, 87107, United States

  • Velocity Clinical Research - Baton Rouge

    RECRUITING

    Baton Rouge, Louisiana, 70809, United States

  • Velocity Clinical Research - Boise

    RECRUITING

    Meridian, Idaho, 83642, United States

  • Velocity Clinical Research - Cleveland

    RECRUITING

    Beachwood, Ohio, 44122, United States

  • Velocity Clinical Research - Denver

    RECRUITING

    Englewood, Colorado, 80110, United States

  • Velocity Clinical Research - Grants Pass

    COMPLETED

    Grants Pass, Oregon, 97527, United States

  • Velocity Clinical Research - Hallandale Beach

    RECRUITING

    Hallandale, Florida, 33009, United States

  • Velocity Clinical Research - Medford

    RECRUITING

    Medford, Oregon, 97504, United States

  • Velocity Clinical Research - Norfolk

    RECRUITING

    Norfolk, Nebraska, 68701, United States

  • Velocity Clinical Research - Providence

    RECRUITING

    East Greenwich, Rhode Island, 02818, United States

  • Velocity Clinical Research - Salt Lake City

    RECRUITING

    West Jordan, Utah, 84088, United States

  • Velocity Clinical Research - Spartanburg

    RECRUITING

    Spartanburg, South Carolina, 29303, United States

  • Velocity Clinical Research - Syracuse

    RECRUITING

    East Syracuse, New York, 13057, United States

  • Velocity Clinical Research - Waco

    RECRUITING

    Waco, Texas, 76710, United States

  • Velocity Clinical Research - Washington DC

    RECRUITING

    Washington D.C., District of Columbia, 20016, United States

  • Velocity Clinical Research, San Bernardino

    RECRUITING

    San Bernardino, California, 92408, United States

  • West Clinical Research

    RECRUITING

    Morehead City, North Carolina, 28557, United States

  • Zenos Clinical Research

    RECRUITING

    Dallas, Texas, 75230, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.