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

May 18, 2026 updated by: Vertex Pharmaceuticals Incorporated

A Phase 3, Randomized, Double-blind, Placebo-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 in participants with pain associated with diabetic peripheral neuropathy (DPN).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

734

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
      • Birmingham, Alabama, United States, 35216
        • Recruiting
        • Accel Research - Birmingham
      • Birmingham, Alabama, United States, 35205
        • Recruiting
        • Central Research Associates, LLC
      • Mobile, Alabama, United States, 36608
        • Recruiting
        • AMR Mobile
    • Arizona
      • Glendale, Arizona, United States, 85304
        • Recruiting
        • Sun City Clinical Research
      • Scottsdale, Arizona, United States, 85260
        • Recruiting
        • Scottsdale Clinical Trials
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Recruiting
        • Lynn Institute of the Ozarks
    • California
      • Canoga Park, California, United States, 91303
        • Recruiting
        • HOPE Clinical Research
      • Huntington Beach, California, United States, 92647
        • Recruiting
        • Marvel Clinical Research
      • La Mesa, California, United States, 91942
        • Recruiting
        • Eximia Research-CA, LLC
      • Long Beach, California, United States, 90805
        • Recruiting
        • Long Beach Research Institute
      • Modesto, California, United States, 95355
        • Recruiting
        • Paradigm Clincial Research - Modesto
      • Pasadena, California, United States, 91101
        • Recruiting
        • Pasadena Clinical Trials
      • Riverside, California, United States, 92503
        • Recruiting
        • Artemis Institute for Clinical Research - Riverside
      • San Bernardino, California, United States, 92408
        • Recruiting
        • Velocity Clinical Research -San Bernardino
    • Colorado
      • Boulder, Colorado, United States, 80301
        • Recruiting
        • Alpine Clinical Research Center
      • Wheat Ridge, Colorado, United States, 80033
        • Recruiting
        • Paradigm Clinical Research - Wheat Ridge
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Recruiting
        • Chase Medical Research
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Recruiting
        • Velocity Clinical Research - Washington DC
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Recruiting
        • Neurology Offices of South Florida, PLLC
      • DeLand, Florida, United States, 32720
        • Recruiting
        • Accel Research - Deland
      • Hallandale, Florida, United States, 33009
        • Recruiting
        • Velocity Clinical Research - Hallandale Beach
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • CNS Healthcare - Jacksonville
      • Jupiter, Florida, United States, 33458
        • Recruiting
        • Health Awareness, Inc. - Jupiter
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • 3Sync Research -Miami Lakes
      • Naples, Florida, United States, 34105
        • Recruiting
        • Aqualane Clinical Research
      • Orlando, Florida, United States, 32806
        • Recruiting
        • CNS Healthcare - Orlando
      • Palm Harbor, Florida, United States, 34684
        • Recruiting
        • Suncoast Clinical Research - Palm Harbor
      • Palm Springs, Florida, United States, 33461
        • Recruiting
        • 3Sync Research - Palm Springs
      • Port Saint Lucie, Florida, United States, 34952
        • Recruiting
        • Health Awareness, Inc. - Port St. Lucie
      • Viera, Florida, United States, 32940
        • Recruiting
        • ClinCloud - Viera
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Conquest Clinical Research - Winter Park
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Recruiting
        • Atlanta Center for Medical Research
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • Accel Research - Decatur
      • Fayetteville, Georgia, United States, 30214
        • Recruiting
        • Javara Inc./Privia Medical Group - Fayetteville, GA
      • Savannah, Georgia, United States, 31406
        • Recruiting
        • Velocity Clinical Research - Savannah
    • Illinois
      • Tinley Park, Illinois, United States, 60477
        • Recruiting
        • Healthcare Research Network - Flossmoor IL
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Recruiting
        • Velocity Clinical Research - Baton Rouge
      • Lafayette, Louisiana, United States, 70508
        • Recruiting
        • Velocity Clinical Research - Lafayette
    • Maryland
      • Rockville, Maryland, United States, 20854
        • Recruiting
        • Velocity Clinical Research - Rockville
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Recruiting
        • Boston Clinical Trials
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Quest Research Institute
    • Mississippi
      • Gulfport, Mississippi, United States, 39503
        • Recruiting
        • Velocity Clinical Research - Gulfport
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Recruiting
        • SCLA Management - St. Louis Pain Consultants
      • Hazelwood, Missouri, United States, 63042
        • Recruiting
        • Healthcare Research Network - Hazelwood MO
      • Kansas City, Missouri, United States, 64114
        • Recruiting
        • AMR Kansas City
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • M3 Wake Research - Las Vegas
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • CenExel AMRI
    • New York
      • Brooklyn, New York, United States, 11226
        • Recruiting
        • Brooklyn Clinical Research
      • East Syracuse, New York, United States, 13057
        • Recruiting
        • Velocity Clinical Research - Syracuse
      • New Windsor, New York, United States, 12553
        • Recruiting
        • Mid Hudson Medical Research, PLLC
      • Rochester, New York, United States, 14609
        • Recruiting
        • Rochester Clinical Research - Rochester
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Recruiting
        • Asheville Clinical Research
      • Monroe, North Carolina, United States, 28112
        • Recruiting
        • Monroe Biomedical Research
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • West Clinical Research
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Recruiting
        • Velocity Clinical Research - Cleveland
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • Velocity Clinical Research - Cincinnati - Blue Ash
    • Oklahoma
      • Norman, Oklahoma, United States, 73072
        • Recruiting
        • Lynn Institute of Norman
    • Oregon
      • Medford, Oregon, United States, 97504
        • Recruiting
        • Velocity Clinical Research - Medford
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Recruiting
        • Velocity Clinical Research - Providence
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Recruiting
        • Velocity Clinical Research - Anderson
      • North Charleston, South Carolina, United States, 29405
        • Recruiting
        • Coastal Carolina Research Center
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Velocity Clinical Research - Spartanburg
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Recruiting
        • M3 Wake Research - Chattanooga
      • Kingsport, Tennessee, United States, 37660
        • Recruiting
        • Holston Medical Group
      • Knoxville, Tennessee, United States, 37909
        • Recruiting
        • AMR Knoxville, TN
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • CNS Healthcare - Memphis
    • Texas
      • Amarillo, Texas, United States, 79124
        • Recruiting
        • Amarillo Medical Specialists LLP
      • Austin, Texas, United States, 78759
        • Recruiting
        • QCR - BioBehavioral Research of Austin
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Zenos Clinical Research
      • Fort Worth, Texas, United States, 76132
        • Recruiting
        • Fort Worth Endocrine Research Center
      • Lewisville, Texas, United States, 75057
        • Recruiting
        • Epic Clinical Research
      • Mansfield, Texas, United States, 76063
        • Recruiting
        • Prime Clinical Research - Mansfield - US 287
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Clinical Trials of Texas, LLC
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • AMR Norfolk
    • Washington
      • Spokane, Washington, United States, 99218
        • Recruiting
        • Velocity Clinical Research - Spokane

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 to less than (<) 40 kilogram per meter square (kg/m^2)
  • Diagnosis of diabetes mellitus type 1 or type 2 and with glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pain in lower extremities due to DPN for at least 1 year
  • 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
  • Received Journavx within 30 days of study drug dosing
  • 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
Experimental: Suzetrigine (SUZ)
Participants will be randomized to receive SUZ.
Drug: Suzetrigine
Tablets for oral administration
Other Names:
  • VX-548
  • SUZ
Placebo Comparator: Placebo
Participants will be randomized to receive placebo matched to SUZ.
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 VX24-548-110)
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)

November 21, 2025

Primary Completion (Estimated)

April 6, 2027

Study Completion (Estimated)

April 6, 2027

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • VX24-548-111

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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