Recruiting

Phase 3

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

Sponsor:

Vertex Pharmaceuticals Incorporated

Code:

NCT07231419

Conditions

Diabetic Peripheral Neuropathic Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Suzetrigine

Placebo (matched to SUZ)

Study Details

Brief summary:

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).

Conditions

Diabetic Peripheral Neuropathic Pain

Study ID

NCT07231419

Start date

Nov 21, 2025

Status verified date

Jul, 2026

Completion date

Apr 6, 2027

Anticipated

Primary completion date

Apr 6, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

734 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Suzetrigine (SUZ)

Participants will be randomized to receive SUZ.

placebo comparator: Placebo

Participants will be randomized to receive placebo matched to SUZ.

Interventions

Suzetrigine

Tablets for oral administration

Placebo (matched to SUZ)

Placebo matched to SUZ for oral administration.

Primary outcome measure

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 ]

Central Contacts and Locations

Central contacts

Medical Information

6173416777 medicalinfo@vrtx.com

Locations

Central Research Associates, LLC

Recruiting

Birmingham, Alabama, United States, 35205

Accel Research - Birmingham

Recruiting

Birmingham, Alabama, United States, 35216

Sun City Clinical Research

Recruiting

Glendale, Arizona, United States, 85304

Scottsdale Clinical Trials

Recruiting

Scottsdale, Arizona, United States, 85260

Lynn Institute of the Ozarks

Recruiting

Little Rock, Arkansas, United States, 72204

Hope Clinical Research

Recruiting

Canoga Park, California, United States, 91303

Marvel Clinical Research

Recruiting

Huntington Beach, California, United States, 92647

Eximia Research-CA, LLC

Recruiting

La Mesa, California, United States, 91942

Long Beach Research Institute

Recruiting

Long Beach, California, United States, 90805

Paradigm Clincial Research - Modesto

Recruiting

Modesto, California, United States, 95355

Pasadena Clinical Trials

Recruiting

Pasadena, California, United States, 91101

Artemis Institute for Clinical Research - Riverside

Recruiting

Riverside, California, United States, 92503

Velocity Clinical Research -San Bernardino

Recruiting

San Bernardino, California, United States, 92408

Alpine Clinical Research Center

Recruiting

Boulder, Colorado, United States, 80301

Paradigm Clinical Research - Wheat Ridge

Recruiting

Wheat Ridge, Colorado, United States, 80033

Chase Medical Research

Recruiting

Waterbury, Connecticut, United States, 06708

Velocity Clinical Research - Washington DC

Recruiting

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

Neurology Offices of South Florida, PLLC

Recruiting

Boca Raton, Florida, United States, 33428

Accel Research - Deland

Recruiting

DeLand, Florida, United States, 32720

Velocity Clinical Research - Hallandale Beach

Recruiting

Hallandale, Florida, United States, 33009

CNS Healthcare - Jacksonville

Recruiting

Jacksonville, Florida, United States, 32256

Health Awareness, Inc. - Jupiter

Recruiting

Jupiter, Florida, United States, 33458

3Sync Research -Miami Lakes

Recruiting

Miami Lakes, Florida, United States, 33014

CNS Healthcare - Orlando

Recruiting

Orlando, Florida, United States, 32806

3Sync Research - Palm Springs

Recruiting

Palm Springs, Florida, United States, 33461

Health Awareness, Inc. - Port St. Lucie

Recruiting

Port Saint Lucie, Florida, United States, 34952

ClinCloud - Viera

Recruiting

Viera, Florida, United States, 32940

Conquest Clinical Research - Winter Park

Recruiting

Winter Park, Florida, United States, 32789

Atlanta Center for Medical Research

Recruiting

Atlanta, Georgia, United States, 30331

Accel Research - Decatur

Recruiting

Decatur, Georgia, United States, 30030

Javara Inc./Privia Medical Group - Fayetteville, GA

Recruiting

Fayetteville, Georgia, United States, 30214

Velocity Clinical Research - Savannah

Recruiting

Savannah, Georgia, United States, 31406

Healthcare Research Network - Flossmoor IL

Recruiting

Tinley Park, Illinois, United States, 60477

Velocity Clinical Research - Baton Rouge

Recruiting

Baton Rouge, Louisiana, United States, 70809

Velocity Clinical Research - Lafayette

Recruiting

Lafayette, Louisiana, United States, 70508

Velocity Clinical Research - Rockville

Recruiting

Rockville, Maryland, United States, 20854

Boston Clinical Trials

Recruiting

Boston, Massachusetts, United States, 02131

Quest Research Institute

Recruiting

Farmington Hills, Michigan, United States, 48334

Velocity Clinical Research - Gulfport

Recruiting

Gulfport, Mississippi, United States, 39503

Healthcare Research Network - Hazelwood MO

Recruiting

Hazelwood, Missouri, United States, 63042

AMR Kansas City

Recruiting

Kansas City, Missouri, United States, 64114

M3 Wake Research - Las Vegas

Recruiting

Las Vegas, Nevada, United States, 89106

CenExel AMRI

Recruiting

Toms River, New Jersey, United States, 08755

Brooklyn Clinical Research

Recruiting

Brooklyn, New York, United States, 11226

Velocity Clinical Research - Syracuse

Recruiting

East Syracuse, New York, United States, 13057

Mid Hudson Medical Research, PLLC

Recruiting

New Windsor, New York, United States, 12553

Rochester Clinical Research - Rochester

Recruiting

Rochester, New York, United States, 14609

Asheville Clinical Research

Recruiting

Asheville, North Carolina, United States, 28803

Monroe Biomedical research

Recruiting

Monroe, North Carolina, United States, 28112

West Clinical Research

Recruiting

Morehead City, North Carolina, United States, 28557

Velocity Clinical Research - Cleveland

Recruiting

Beachwood, Ohio, United States, 44122

Velocity Clinical Research - Cincinnati - Blue Ash

Recruiting

Cincinnati, Ohio, United States, 45242

Lynn Institute of Norman

Recruiting

Norman, Oklahoma, United States, 73072

Velocity Clinical Research - Medford

Recruiting

Medford, Oregon, United States, 97504

Velocity Clinical Research - Providence

Recruiting

East Greenwich, Rhode Island, United States, 02818

Velocity Clinical Research - Anderson

Recruiting

Anderson, South Carolina, United States, 29621

Coastal Carolina Research Center

Recruiting

North Charleston, South Carolina, United States, 29405

Velocity Clinical Research - Spartanburg

Recruiting

Spartanburg, South Carolina, United States, 29303

M3 Wake Research - Chattanooga

Recruiting

Chattanooga, Tennessee, United States, 37421

Holston Medical Group

Recruiting

Kingsport, Tennessee, United States, 37660

CNS Healthcare - Memphis

Recruiting

Memphis, Tennessee, United States, 38119

Amarillo Medical Specialists LLP

Recruiting

Amarillo, Texas, United States, 79124

QCR - BioBehavioral Research of Austin

Recruiting

Austin, Texas, United States, 78759

Zenos Clinical Research

Recruiting

Dallas, Texas, United States, 75230

Fort Worth Endocrine Research Center

Recruiting

Fort Worth, Texas, United States, 76132

Epic Clinical Research

Recruiting

Lewisville, Texas, United States, 75057

Prime Clinical Research - Mansfield - US 287

Recruiting

Mansfield, Texas, United States, 76063

Clinical Trials of Texas, LLC

Recruiting

San Antonio, Texas, United States, 78229

AMR Norfolk

Recruiting

Norfolk, Virginia, United States, 23502

Velocity Clinical Research - Spokane

Recruiting

Spokane, Washington, United States, 99218

More Information

Sponsor

Vertex Pharmaceuticals Incorporated

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Vertex Pharmaceuticals Incorporated on 2026-07-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.