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NCT07231419PHASE3Recruiting

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

Vertex Pharmaceuticals Incorporated

Start Date

11/21/2025

Completion Date

4/6/2027

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).

Eligibility Criteria

Age Range: 18 years to 80 years

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.

Interventions

DRUG

Suzetrigine

DRUG

Placebo (matched to SUZ)

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Conditions

Diabetic Peripheral Neuropathic Pain

Locations

Central Research Associates, LLC

Birmingham, Alabama 35205

United States

Accel Research - Birmingham

Birmingham, Alabama 35216

United States

AMR Mobile

Mobile, Alabama 36608

United States

Sun City Clinical Research

Glendale, Arizona 85304

United States

Scottsdale Clinical Trials

Scottsdale, Arizona 85260

United States

Lynn Institute of the Ozarks

Little Rock, Arkansas 72204

United States

Hope Clinical Research

Canoga Park, California 91303

United States

Marvel Clinical Research

Huntington Beach, California 92647

United States

Eximia Research-CA, LLC

La Mesa, California 91942

United States

Long Beach Research Institute

Long Beach, California 90805

United States

Paradigm Clincial Research - Modesto

Modesto, California 95355

United States

Pasadena Clinical Trials

Pasadena, California 91101

United States

Artemis Institute for Clinical Research - Riverside

Riverside, California 92503

United States

Velocity Clinical Research -San Bernardino

San Bernardino, California 92408

United States

Alpine Clinical Research Center

Boulder, Colorado 80301

United States

Paradigm Clinical Research - Wheat Ridge

Wheat Ridge, Colorado 80033

United States

Chase Medical Research

Waterbury, Connecticut 06708

United States

Velocity Clinical Research - Washington DC

Washington D.C., District of Columbia 20016

United States

Neurology Offices of South Florida, PLLC

Boca Raton, Florida 33428

United States

Accel Research - Deland

DeLand, Florida 32720

United States

Velocity Clinical Research - Hallandale Beach

Hallandale, Florida 33009

United States

CNS Healthcare - Jacksonville

Jacksonville, Florida 32256

United States

Health Awareness, Inc. - Jupiter

Jupiter, Florida 33458

United States

3Sync Research -Miami Lakes

Miami Lakes, Florida 33014

United States

Aqualane Clinical Research

Naples, Florida 34105

United States

CNS Healthcare - Orlando

Orlando, Florida 32806

United States

Suncoast Clinical Research - Palm Harbor

Palm Harbor, Florida 34684

United States

3Sync Research - Palm Springs

Palm Springs, Florida 33461

United States

Health Awareness, Inc. - Port St. Lucie

Port Saint Lucie, Florida 34952

United States

ClinCloud - Viera

Viera, Florida 32940

United States

Conquest Clinical Research - Winter Park

Winter Park, Florida 32789

United States

Atlanta Center for Medical Research

Atlanta, Georgia 30331

United States

Accel Research - Decatur

Decatur, Georgia 30030

United States

Javara Inc./Privia Medical Group - Fayetteville, GA

Fayetteville, Georgia 30214

United States

Velocity Clinical Research - Savannah

Savannah, Georgia 31406

United States

Healthcare Research Network - Flossmoor IL

Tinley Park, Illinois 60477

United States

Velocity Clinical Research - Baton Rouge

Baton Rouge, Louisiana 70809

United States

Velocity Clinical Research - Lafayette

Lafayette, Louisiana 70508

United States

Velocity Clinical Research - Rockville

Rockville, Maryland 20854

United States

Boston Clinical Trials

Boston, Massachusetts 02131

United States

Quest Research Institute

Farmington Hills, Michigan 48334

United States

Velocity Clinical Research - Gulfport

Gulfport, Mississippi 39503

United States

SCLA Management - St. Louis Pain Consultants

Creve Coeur, Missouri 63141

United States

Healthcare Research Network - Hazelwood MO

Hazelwood, Missouri 63042

United States

AMR Kansas City

Kansas City, Missouri 64114

United States

M3 Wake Research - Las Vegas

Las Vegas, Nevada 89106

United States

CenExel AMRI

Toms River, New Jersey 08755

United States

Brooklyn Clinical Research

Brooklyn, New York 11226

United States

Velocity Clinical Research - Syracuse

East Syracuse, New York 13057

United States

Mid Hudson Medical Research, PLLC

New Windsor, New York 12553

United States

Rochester Clinical Research - Rochester

Rochester, New York 14609

United States

Asheville Clinical Research

Asheville, North Carolina 28803

United States

Monroe Biomedical research

Monroe, North Carolina 28112

United States

West Clinical Research

Morehead City, North Carolina 28557

United States

Velocity Clinical Research - Cleveland

Beachwood, Ohio 44122

United States

Velocity Clinical Research - Cincinnati - Blue Ash

Cincinnati, Ohio 45242

United States

Lynn Institute of Norman

Norman, Oklahoma 73072

United States

Velocity Clinical Research - Medford

Medford, Oregon 97504

United States

Velocity Clinical Research - Providence

East Greenwich, Rhode Island 02818

United States

Velocity Clinical Research - Anderson

Anderson, South Carolina 29621

United States

Coastal Carolina Research Center

North Charleston, South Carolina 29405

United States

Velocity Clinical Research - Spartanburg

Spartanburg, South Carolina 29303

United States

M3 Wake Research - Chattanooga

Chattanooga, Tennessee 37421

United States

Holston Medical Group

Kingsport, Tennessee 37660

United States

AMR Knoxville, TN

Knoxville, Tennessee 37909

United States

CNS Healthcare - Memphis

Memphis, Tennessee 38119

United States

Amarillo Medical Specialists LLP

Amarillo, Texas 79124

United States

QCR - BioBehavioral Research of Austin

Austin, Texas 78759

United States

Zenos Clinical Research

Dallas, Texas 75230

United States

Fort Worth Endocrine Research Center

Fort Worth, Texas 76132

United States

Epic Clinical Research

Lewisville, Texas 75057

United States

Prime Clinical Research - Mansfield - US 287

Mansfield, Texas 76063

United States

Clinical Trials of Texas, LLC

San Antonio, Texas 78229

United States

AMR Norfolk

Norfolk, Virginia 23502

United States

Velocity Clinical Research - Spokane

Spokane, Washington 99218

United States