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

April 27, 2026 updated by: Vertex Pharmaceuticals Incorporated

A Phase 3, Randomized, Double-blind, Placebo- and Active-Controlled Study of the Efficacy and Safety of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Recruiting
        • Pinnacle Research Group, LLC
      • Birmingham, Alabama, United States, 35211
        • Completed
        • Synexus Clinical Research - Birmingham
      • Daphne, Alabama, United States, 36526
        • Completed
        • AMR Daphne, AL
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Completed
        • Synexus Clinical Research - Phoenix Central
      • Scottsdale, Arizona, United States, 85260
        • Recruiting
        • Scottsdale Clinical Trials
    • California
      • Fresno, California, United States, 93710
        • Recruiting
        • Neuro-Pain Medical Center
      • Long Beach, California, United States, 90805
        • Recruiting
        • Long Beach Research Institute
      • Los Angeles, California, United States, 90010
        • Recruiting
        • Angel City Research, Inc
      • Pomona, California, United States, 91767
        • Recruiting
        • Empire Clinical Research
      • Sacramento, California, United States, 95821
        • Recruiting
        • Clinical Trials Research
      • San Bernardino, California, United States, 92408
        • Recruiting
        • Velocity Clinical Research, San Bernardino
      • Thousand Oaks, California, United States, 91320
        • Recruiting
        • SCLA Management - Pain Management and Injury Relief
      • Walnut Creek, California, United States, 94598
        • Completed
        • Diablo Clinical Research (DCR)
    • Colorado
      • Englewood, Colorado, United States, 80110
        • Recruiting
        • Velocity Clinical Research - Denver
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Recruiting
        • Velocity Clinical Research - Washington DC
    • Florida
      • DeLand, Florida, United States, 32720
        • Recruiting
        • Accel Research - Deland
      • Doral, Florida, United States, 33172
        • Recruiting
        • AMR-Miami
      • Fort Myers, Florida, United States, 33912
        • Recruiting
        • AMR Fort Myers (The Clinical Study Center)
      • Hallandale, Florida, United States, 33009
        • Recruiting
        • Velocity Clinical Research - Hallandale Beach
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • CNS Healthcare - Jacksonville
      • Largo, Florida, United States, 33777
        • Recruiting
        • Accel Research - St. Petersburg-Largo
      • Maitland, Florida, United States, 32751
        • Completed
        • Accel Research - Maitland
      • Miami, Florida, United States, 33172
        • Recruiting
        • Suncoast Research Associates - Miami
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • 3Sync Research - Miami Lakes
      • New Port Richey, Florida, United States, 34652
        • Recruiting
        • Suncoast Clinical Research - New Port Richey
      • Orlando, Florida, United States, 32806
        • Completed
        • Synexus Clinical Research - Orlando
      • Orlando, Florida, United States, 32832
        • Recruiting
        • Conquest Clinical Research - Orlando - Neuro
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Conquest Clinical Research - Winter Park
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • Accel Research - Decatur
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Velocity Clinical Research - Boise
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Feinberg School of Medicine - Anesthesiology
      • Flossmoor, Illinois, United States, 604773027
        • Recruiting
        • Healthcare Research Network - Flossmoor IL
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Completed
        • Synexus Clinical Research - Evansville
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Recruiting
        • AMR Wichita East, KS (Heartland Research Associates)
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Recruiting
        • AMR Lexington
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Recruiting
        • Velocity Clinical Research - Baton Rouge
      • Covington, Louisiana, United States, 70433
        • Recruiting
        • Tandem Clinical Research- Covington
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Mass General Brigham - Brigham and Women's Hospital - Main Campus
      • Waltham, Massachusetts, United States, 02451
        • Recruiting
        • MedVadis Research Corporation
    • Missouri
      • Hazelwood, Missouri, United States, 63042
        • Recruiting
        • Healthcare Research Network - Hazelwood MO
      • Kansas City, Missouri, United States, 64114
        • Recruiting
        • AMR Kansas City
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • St. Louis Children's Hospital - Nephrology
      • St Louis, Missouri, United States, 63141
        • Completed
        • Synexus Clinical Research - St. Louis
    • Nebraska
      • Norfolk, Nebraska, United States, 68701
        • Recruiting
        • Velocity Clinical Research - Norfolk
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • Completed
        • Synexus Clinical Research - Las Vegas
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Completed
        • HRI - Hassman Research Institute
    • New Mexico
      • Albuquerque, New Mexico, United States, 87107
        • Recruiting
        • Velocity Clinical Research - Albuquerque
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical College
      • Brooklyn, New York, United States, 11226
        • Recruiting
        • Swift Clinical OpCo, Inc
      • East Syracuse, New York, United States, 13057
        • Recruiting
        • Velocity Clinical Research - Syracuse
      • New York, New York, United States, 10017
        • Completed
        • Synexus Clinical Research - New York (DRS)
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia Presbyterian - The Neurological Institute of New York
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • West Clinical Research
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • Eximia Research - Raleigh
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Carolinas Pain Institute - Winston-Salem Office
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Recruiting
        • Velocity Clinical Research - Cleveland
      • Cincinnati, Ohio, United States, 45236
        • Completed
        • Synexus Clinical Research - Cincinnati
      • Dayton, Ohio, United States, 45432
        • Recruiting
        • META Medical Research Institute
    • Oregon
      • Grants Pass, Oregon, United States, 97527
        • Completed
        • Velocity Clinical Research - Grants Pass
      • Medford, Oregon, United States, 97504
        • Recruiting
        • Velocity Clinical Research - Medford
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Recruiting
        • Suburban Research Associates - Media
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Recruiting
        • Velocity Clinical Research - Providence
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Completed
        • Synexus Clinical Research- Anderson
      • Charleston, South Carolina, United States, 29406
        • Recruiting
        • Clinical Trials of South Carolina - Berkeley - Charleston
      • Charleston, South Carolina, United States, 29414
        • Recruiting
        • M3 Wake Research - Charleston
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Velocity Clinical Research - Spartanburg
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Completed
        • AMR Nashville, TN
    • Texas
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Zenos Clinical Research
      • Dallas, Texas, United States, 75234
        • Completed
        • Synexus Clinical Research - Dallas (DFW) (DRS)
      • Round Rock, Texas, United States, 78681
        • Recruiting
        • Be Well Clinical Studies - Austin
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • San Antonio Clinical Trials
      • Waco, Texas, United States, 76710
        • Recruiting
        • Velocity Clinical Research - Waco
    • Utah
      • West Jordan, Utah, United States, 84088
        • Recruiting
        • Velocity Clinical Research - Salt Lake City
      • West Valley City, Utah, United States, 84120
        • Recruiting
        • Kalo Clinical Research - West Valley City
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • Dominion Medical Associates, Inc.
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Northwest Clinical Research Center (NWCRC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pregabalin
Participants will be randomized to receive Pregabalin.
Drug: Pregabalin
Capsules for oral administration.
Drug: Placebo (matched to SUZ)
Placebo matched to SUZ for oral administration.
Experimental: Suzetrigine (SUZ)
Participants will be randomized to receive SUZ.
Drug: Suzetrigine
Tablets for oral administration.
Other Names:
  • VX-548
  • SUZ
Drug: Placebo (matched to Pregabalin)
Placebo matched to Pregabalin for oral administration.
Placebo Comparator: Placebo
Participants will be randomized to receive placebo matched to SUZ and Pregabalin.
Drug: Placebo (matched to Pregabalin)
Placebo matched to Pregabalin for oral administration.
Drug: Placebo (matched to SUZ)
Placebo matched to SUZ for oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 Compared to Placebo
Time Frame: From Baseline up to Week 12
From Baseline up to Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in the Medical Outcomes Study 36-item Short-form Health Status (SF 36v2) Physical Component Summary (PCS) Score at Week 12 Compared to Placebo (pooled with data from Study VX24-548-111)
Time Frame: From Baseline up to Week 12
From Baseline up to Week 12
Change From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12 Compared to Pregabalin
Time Frame: From Baseline up to Week 12
From Baseline up to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

September 30, 2024

First Submitted That Met QC Criteria

October 3, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX24-548-110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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