Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy

Last updated: October 13, 2025
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Active - Recruiting

Phase

3

Condition

Pain

Pain (Pediatric)

Neurologic Disorders

Treatment

Pregabalin

Placebo (matched to Pregabalin)

Suzetrigine

Clinical Study ID

NCT06628908
VX24-548-110
  • Ages 18-80
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with diabetic peripheral neuropathy (DPN).

Eligibility Criteria

Inclusion

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 limitedvariation in the 7-day Baseline Period

Exclusion

Key Exclusion Criteria:

  • More than 3 missing daily NPRS scores during the 7-day Baseline Period

  • Participation in a previous study in which the participant received SUZ

  • Any sensory abnormality (excluding DPN) as pre-specified in the protocol

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 1100
Treatment Group(s): 4
Primary Treatment: Pregabalin
Phase: 3
Study Start date:
October 01, 2024
Estimated Completion Date:
May 31, 2027

Connect with a study center

  • Pinnacle Research Group, LLC

    Anniston, Alabama 36207
    United States

    Site Not Available

  • Synexus Clinical Research US - Birmingham

    Birmingham, Alabama 35211
    United States

    Site Not Available

  • AMR Daphne, AL

    Daphne, Alabama 36526
    United States

    Site Not Available

  • Pinnacle Research Group, LLC

    Anniston 4830198, Alabama 4829764 36207
    United States

    Active - Recruiting

  • Synexus Clinical Research - Birmingham

    Birmingham 4049979, Alabama 4829764 35211
    United States

    Completed

  • Synexus Clinical Research US - Birmingham

    Birmingham 4049979, Alabama 4829764 35211
    United States

    Completed

  • AMR Daphne, AL

    Daphne 4058219, Alabama 4829764 36526
    United States

    Completed

  • Synexus Clinical Research US - Phoenix Central

    Phoenix, Arizona 85020
    United States

    Site Not Available

  • Scottsdale Clinical Trials

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Synexus Clinical Research - Phoenix Central

    Phoenix 5308655, Arizona 5551752 85020
    United States

    Completed

  • Synexus Clinical Research US - Phoenix Central

    Phoenix 5308655, Arizona 5551752 85020
    United States

    Completed

  • Scottsdale Clinical Trials

    Scottsdale 5313457, Arizona 5551752 85260
    United States

    Active - Recruiting

  • Neuro-Pain Medical Center

    Fresno, California 93710
    United States

    Site Not Available

  • Long Beach Research Institute

    Long Beach, California 90805
    United States

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  • Angel City Research, Inc

    Los Angeles, California 90010
    United States

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    Pomona, California 91767
    United States

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    Sacramento, California 95821
    United States

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    San Bernardino, California 92408
    United States

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  • Velocity Clinical Research, San Bernardino

    San Bernardino, California 92408
    United States

    Site Not Available

  • Pain Management and Injury Relief

    Thousand Oaks, California 91320
    United States

    Site Not Available

  • Diablo Clinical Research

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Neuro-Pain Medical Center

    Fresno 5350937, California 5332921 93710
    United States

    Active - Recruiting

  • Long Beach Research Institute

    Long Beach 5367929, California 5332921 90805
    United States

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    Los Angeles 5368361, California 5332921 90010
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    Sacramento 5389489, California 5332921 95821
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  • Velocity Clinical Research, San Bernardino

    San Bernardino 5391710, California 5332921 92408
    United States

    Active - Recruiting

  • Pain Management and Injury Relief

    Thousand Oaks 5402405, California 5332921 91320
    United States

    Active - Recruiting

  • SCLA Management - Pain Management and Injury Relief

    Thousand Oaks 5402405, California 5332921 91320
    United States

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    Walnut Creek 5406990, California 5332921 94598
    United States

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    United States

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    United States

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    Fort Myers, Florida 33912
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    Hallandale Beach, Florida 33009
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    Jacksonville, Florida 32256
    United States

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    Miami, Florida 33137
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  • AMR-Miami

    Doral 4153471, Florida 4155751 33172
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  • AMR Fort Myers (The Clinical Study Center)

    Fort Myers 4155995, Florida 4155751 33912
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    Hallandale 4157898, Florida 4155751 33009
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    Jacksonville 4160021, Florida 4155751 32256
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  • Clinical Neuroscience Solutions, Inc.

    Jacksonville 4160021, Florida 4155751 32256
    United States

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  • Feinberg School of Medicine

    Chicago, Illinois 60611
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  • Healthcare Research Network II, LLC

    Flossmoor, Illinois 60422
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  • Feinberg School of Medicine

    Chicago 4887398, Illinois 4896861 60611
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  • Feinberg School of Medicine - Anesthesiology

    Chicago 4887398, Illinois 4896861 60611
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  • Healthcare Research Network - Flossmoor IL

    Flossmoor 4892684, Illinois 4896861 604773027
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    Flossmoor 4892684, Illinois 4896861 60422
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    Evansville, Indiana 47714
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    Wichita, Kansas 67207
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    Wichita 4281730, Kansas 4273857 67207
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  • AMR Wichita East, KS (Heartland Research Associates)

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    Lexington, Kentucky 40509
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    Boston, Massachusetts 02115
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    Waltham, Massachusetts 02451
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    Boston 4930956, Massachusetts 6254926 02115
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    Waltham 4954380, Massachusetts 6254926 02451
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    Hazelwood, Missouri 63042
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    Kansas City, Missouri 64114
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    Saint Louis, Missouri 63141
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    Hazelwood 4389967, Missouri 4398678 63042
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    Hazelwood 4389967, Missouri 4398678 63042
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  • AMR Kansas City

    Kansas City 4393217, Missouri 4398678 64114
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  • St. Louis Children's Hospital - Nephrology

    St Louis 4407066, Missouri 4398678 63110
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    St Louis 4407066, Missouri 4398678 63141
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    St Louis 4407066, Missouri 4398678 63141
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  • Velocity Clinical Research - Norfolk

    Norfolk, Nebraska 68701
    United States

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    Norfolk 5073965, Nebraska 5073708 68701
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  • Synexus Clinical Research - Henderson

    Las Vegas, Nevada 89113
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    Las Vegas 5506956, Nevada 5509151 89113
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  • Hassman Research Institute

    Marlton, New Jersey 08053
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  • HRI - Hassman Research Institute

    Marlton 4502911, New Jersey 5101760 08053
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  • Hassman Research Institute

    Marlton 4502911, New Jersey 5101760 08053
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    Albuquerque, New Mexico 87107
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  • Velocity Clinical Research - Albuquerque

    Albuquerque 5454711, New Mexico 5481136 87107
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  • Albany Medical Center

    Albany, New York 12208
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    Brooklyn, New York 11226
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    East Syracuse, New York 13057
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    New York, New York 10017
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  • The Neurological Institute of New York

    New York, New York 10032
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    Albany 5106834, New York 5128638 12208
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    Albany 5106834, New York 5128638 12208
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    Brooklyn 5110302, New York 5128638 11226
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    East Syracuse 5116079, New York 5128638 13057
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    New York 5128581, New York 5128638 10032
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    New York 5128581, New York 5128638 10017
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  • Synexus Clinical Research- New York

    New York 5128581, New York 5128638 10017
    United States

    Completed

  • The Neurological Institute of New York

    New York 5128581, New York 5128638 10032
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    Active - Recruiting

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    Morehead City, North Carolina 28557
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    Raleigh, North Carolina 27607
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    Raleigh, North Carolina 27607
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    Winston-Salem, North Carolina 27103
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    Morehead City 4480153, North Carolina 4482348 28557
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  • Eximia Research - Raleigh

    Raleigh 4487042, North Carolina 4482348 27607
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    Winston-Salem 4499612, North Carolina 4482348 27103
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    Winston-Salem 4499612, North Carolina 4482348 27103
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    Cincinnati, Ohio 45236
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    Dayton, Ohio 45432
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    Beachwood 5146711, Ohio 5165418 44122
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    Cincinnati 4508722, Ohio 5165418 45236
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    Cincinnati 4508722, Ohio 5165418 45236
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    Dayton 4509884, Ohio 5165418 45432
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    Grants Pass, Oregon 97527
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    Medford, Oregon 97504
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    Grants Pass 5729080, Oregon 5744337 97527
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    Medford 5740099, Oregon 5744337 97504
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    Media, Pennsylvania 19063
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    Media 4559575, Pennsylvania 6254927 19063
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    East Greenwich, Rhode Island 02818
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    East Greenwich 5221875, Rhode Island 5224323 02818
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    Anderson, South Carolina 29621
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    Charleston, South Carolina 29414
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    Charleston, South Carolina 29406
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    Spartanburg, South Carolina 29303
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    Anderson 4569298, South Carolina 4597040 29621
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    Charleston 4574324, South Carolina 4597040 29414
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    Charleston 4574324, South Carolina 4597040 29406
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    Nashville, Tennessee 37203
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    Dallas, Texas 75234
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    Dallas, Texas 75230
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    Round Rock, Texas 78681
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    Waco, Texas 76710
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    Dallas 4684888, Texas 4736286 75234
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    Dallas 4684888, Texas 4736286 75234
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    Round Rock 4724129, Texas 4736286 78681
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    Richmond, Virginia 23219
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    Richmond 4781708, Virginia 6254928 23219
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    Bellevue, Washington 98007
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    Bellevue 5786882, Washington 5815135 98007
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