Recruiting

Phase 3

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

Sponsor:

Vertex Pharmaceuticals Incorporated

Code:

NCT06628908

Conditions

Diabetic Peripheral Neuropathic Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Suzetrigine

Placebo (matched to SUZ)

Pregabalin

Placebo (matched to Pregabalin)

Study Details

Brief 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).

Conditions

Diabetic Peripheral Neuropathic Pain

Study ID

NCT06628908

Start date

Oct 1, 2024

Status verified date

Jun, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 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) ≥18.0 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 Design

Enrollment

1100 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.

active comparator: Pregabalin

Participants will be randomized to receive Pregabalin.

placebo comparator: Placebo

Participants will be randomized to receive placebo matched to SUZ and Pregabalin.

Interventions

Suzetrigine

Tablets for oral administration.

Placebo (matched to SUZ)

Placebo matched to SUZ for oral administration.

Pregabalin

Capsules for oral administration.

Placebo (matched to Pregabalin)

Placebo matched to Pregabalin 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

617-341-6777 medicalinfo@vrtx.com

Locations

Pinnacle Research Group, LLC

Recruiting

Anniston, Alabama, United States, 36207

Scottsdale Clinical Trials

Recruiting

Scottsdale, Arizona, United States, 85260

Neuro-Pain Medical Center

Recruiting

Fresno, California, United States, 93710

Long Beach Research Institute

Recruiting

Long Beach, California, United States, 90805

Angel City Research, Inc

Recruiting

Los Angeles, California, United States, 90010

Empire Clinical Research

Recruiting

Pomona, California, United States, 91767

Clinical Trials Research

Recruiting

Sacramento, California, United States, 95821

Velocity Clinical Research, San Bernardino

Recruiting

San Bernardino, California, United States, 92408

SCLA Management - Pain Management and Injury Relief

Recruiting

Thousand Oaks, California, United States, 91320

Velocity Clinical Research - Denver

Recruiting

Englewood, Colorado, United States, 80110

Velocity Clinical Research - Washington DC

Recruiting

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

Accel Research - Deland

Recruiting

DeLand, Florida, United States, 32720

AMR-Miami

Recruiting

Doral, Florida, United States, 33172

AMR Fort Myers (The Clinical Study Center)

Recruiting

Fort Myers, Florida, United States, 33912

Velocity Clinical Research - Hallandale Beach

Recruiting

Hallandale, Florida, United States, 33009

CNS Healthcare - Jacksonville

Recruiting

Jacksonville, Florida, United States, 32256

Accel Research - St. Petersburg-Largo

Recruiting

Largo, Florida, United States, 33777

Suncoast Research Associates - Miami

Recruiting

Miami, Florida, United States, 33172

3Sync Research - Miami Lakes

Recruiting

Miami Lakes, Florida, United States, 33014

Suncoast Clinical Research - New Port Richey

Recruiting

New Port Richey, Florida, United States, 34652

Conquest Clinical Research - Orlando - Neuro

Recruiting

Orlando, Florida, United States, 32832

Conquest Clinical Research - Winter Park

Recruiting

Winter Park, Florida, United States, 32789

Accel Research - Decatur

Recruiting

Decatur, Georgia, United States, 30030

Velocity Clinical Research - Boise

Recruiting

Meridian, Idaho, United States, 83642

Feinberg School of Medicine - Anesthesiology

Recruiting

Chicago, Illinois, United States, 60611

Healthcare Research Network - Flossmoor IL

Recruiting

Flossmoor, Illinois, United States, 604773027

AMR Wichita East, KS (Heartland Research Associates)

Recruiting

Wichita, Kansas, United States, 67207

AMR Lexington

Recruiting

Lexington, Kentucky, United States, 40509

Velocity Clinical Research - Baton Rouge

Recruiting

Baton Rouge, Louisiana, United States, 70809

Tandem Clinical Research- Covington

Recruiting

Covington, Louisiana, United States, 70433

Mass General Brigham - Brigham and Women's Hospital - Main Campus

Recruiting

Boston, Massachusetts, United States, 02115

MedVadis Research Corporation

Recruiting

Waltham, Massachusetts, United States, 02451

Healthcare Research Network - Hazelwood MO

Recruiting

Hazelwood, Missouri, United States, 63042

AMR Kansas City

Recruiting

Kansas City, Missouri, United States, 64114

St. Louis Children's Hospital - Nephrology

Recruiting

St Louis, Missouri, United States, 63110

Velocity Clinical Research - Norfolk

Recruiting

Norfolk, Nebraska, United States, 68701

Velocity Clinical Research - Albuquerque

Recruiting

Albuquerque, New Mexico, United States, 87107

Swift Clinical OpCo, Inc

Recruiting

Brooklyn, New York, United States, 11226

Velocity Clinical Research - Syracuse

Recruiting

East Syracuse, New York, United States, 13057

Columbia Presbyterian - The Neurological Institute of New York

Recruiting

New York, New York, United States, 10032

West Clinical Research

Recruiting

Morehead City, North Carolina, United States, 28557

Eximia Research - Raleigh

Recruiting

Raleigh, North Carolina, United States, 27607

Carolinas Pain Institute - Winston-Salem Office

Recruiting

Winston-Salem, North Carolina, United States, 27103

Velocity Clinical Research - Cleveland

Recruiting

Beachwood, Ohio, United States, 44122

META Medical Research Institute

Recruiting

Dayton, Ohio, United States, 45432

Velocity Clinical Research - Medford

Recruiting

Medford, Oregon, United States, 97504

Suburban Research Associates - Media

Recruiting

Media, Pennsylvania, United States, 19063

Velocity Clinical Research - Providence

Recruiting

East Greenwich, Rhode Island, United States, 02818

Clinical Trials of South Carolina - Berkeley - Charleston

Recruiting

Charleston, South Carolina, United States, 29406

M3 Wake Research - Charleston

Recruiting

Charleston, South Carolina, United States, 29414

Velocity Clinical Research - Spartanburg

Recruiting

Spartanburg, South Carolina, United States, 29303

Zenos Clinical Research

Recruiting

Dallas, Texas, United States, 75230

Be Well Clinical Studies - Austin

Recruiting

Round Rock, Texas, United States, 78681

San Antonio Clinical Trials

Recruiting

San Antonio, Texas, United States, 78240

Velocity Clinical Research - Waco

Recruiting

Waco, Texas, United States, 76710

Velocity Clinical Research - Salt Lake City

Recruiting

West Jordan, Utah, United States, 84088

Kalo Clinical Research - West Valley City

Recruiting

West Valley City, Utah, United States, 84120

Dominion Medical Associates, Inc.

Recruiting

Richmond, Virginia, United States, 23219

Northwest Clinical Research Center (NWCRC)

Recruiting

Bellevue, Washington, United States, 98007

More Information

Sponsor

Vertex Pharmaceuticals Incorporated

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Vertex Pharmaceuticals Incorporated on 2026-06-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.