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

NCT07231419 | Recruiting Phase 3 FDA Drug

• 1 other identifier: VX24-548-111
• Study Type: interventional
• Target: 734
• Locations: 1 country
• Sites: 65

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 Compared to Placebo

  From Baseline up to Week 12

Secondary Outcomes (1)

• 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)

  From Baseline up to Week 12

Study Arms (2)

Suzetrigine (SUZ)

EXPERIMENTAL

Participants will be randomized to receive SUZ.

Drug: Suzetrigine

Placebo

PLACEBO COMPARATOR

Participants will be randomized to receive placebo matched to SUZ.

Drug: Placebo (matched to SUZ)

Interventions

Suzetrigine DRUG

Tablets for oral administration

Also known as: VX-548, SUZ

Suzetrigine (SUZ)

Placebo (matched to SUZ) DRUG

Placebo matched to SUZ for oral administration.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (65)

Central Research Associates, LLC

Birmingham, Alabama, 35205, United States

RECRUITING

Accel Research - Birmingham

Birmingham, Alabama, 35216, United States

RECRUITING

AMR Mobile

Mobile, Alabama, 36608, United States

RECRUITING

Scottsdale Clinical Trials

Scottsdale, Arizona, 85260, United States

RECRUITING

Hope Clinical Research

Canoga Park, California, 91303, United States

RECRUITING

Marvel Clinical Research

Huntington Beach, California, 92647, United States

RECRUITING

Eximia Research-CA, LLC

La Mesa, California, 91942, United States

RECRUITING

Long Beach Research Institute

Long Beach, California, 90805, United States

RECRUITING

Paradigm Clincial Research - Modesto

Modesto, California, 95355, United States

RECRUITING

Pasadena Clinical Trials

Pasadena, California, 91101, United States

RECRUITING

Velocity Clinical Research -San Bernardino

San Bernardino, California, 92408, United States

RECRUITING

Alpine Clinical Research Center

Boulder, Colorado, 80301, United States

RECRUITING

Paradigm Clinical Research - Wheat Ridge

Wheat Ridge, Colorado, 80033, United States

RECRUITING

Chase Medical Research

Waterbury, Connecticut, 06708, United States

RECRUITING

Velocity Clinical Research - Washington DC

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

RECRUITING

Neurology Offices of South Florida, PLLC

Boca Raton, Florida, 33428, United States

RECRUITING

Accel Research - Deland

DeLand, Florida, 32720, United States

RECRUITING

Velocity Clinical Research - Hallandale Beach

Hallandale, Florida, 33009, United States

RECRUITING

CNS Healthcare - Jacksonville

Jacksonville, Florida, 32256, United States

RECRUITING

Health Awareness, Inc. - Jupiter

Jupiter, Florida, 33458, United States

RECRUITING

3Sync Research -Miami Lakes

Miami Lakes, Florida, 33014, United States

RECRUITING

Aqualane Clinical Research

Naples, Florida, 34105, United States

RECRUITING

CNS Healthcare - Orlando

Orlando, Florida, 32806, United States

RECRUITING

Suncoast Clinical Research - Palm Harbor

Palm Harbor, Florida, 34684, United States

RECRUITING

3Sync Research - Palm Springs

Palm Springs, Florida, 33461, United States

RECRUITING

Health Awareness, Inc. - Port St. Lucie

Port Saint Lucie, Florida, 34952, United States

RECRUITING

ClinCloud - Viera

Viera, Florida, 32940, United States

RECRUITING

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

RECRUITING

Accel Research - Decatur

Decatur, Georgia, 30030, United States

RECRUITING

Javara Inc./Privia Medical Group - Fayetteville, GA

Fayetteville, Georgia, 30214, United States

RECRUITING

Velocity Clinical Research - Savannah

Savannah, Georgia, 31406, United States

RECRUITING

Healthcare Research Network - Flossmoor IL

Tinley Park, Illinois, 60477, United States

RECRUITING

Velocity Clinical Research - Baton Rouge

Baton Rouge, Louisiana, 70809, United States

RECRUITING

Velocity Clinical Research - Lafayette

Lafayette, Louisiana, 70508, United States

RECRUITING

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

RECRUITING

Velocity Clinical Research - Gulfport

Gulfport, Mississippi, 39503, United States

RECRUITING

SCLA Management - St. Louis Pain Consultants

Creve Coeur, Missouri, 63141, United States

RECRUITING

Healthcare Research Network - Hazelwood MO

Hazelwood, Missouri, 63042, United States

RECRUITING

AMR Kansas City

Kansas City, Missouri, 64114, United States

RECRUITING

M3 Wake Research - Las Vegas

Las Vegas, Nevada, 89106, United States

RECRUITING

CenExel AMRI

Toms River, New Jersey, 08755, United States

RECRUITING

Brooklyn Clinical Research

Brooklyn, New York, 11226, United States

RECRUITING

Velocity Clinical Research - Syracuse

East Syracuse, New York, 13057, United States

RECRUITING

Mid Hudson Medical Research, PLLC

New Windsor, New York, 12553, United States

RECRUITING

Rochester Clinical Research - Rochester

Rochester, New York, 14609, United States

RECRUITING

Asheville Clinical Research

Asheville, North Carolina, 28803, United States

RECRUITING

Monroe Biomedical research

Monroe, North Carolina, 28112, United States

RECRUITING

West Clinical Research

Morehead City, North Carolina, 28557, United States

RECRUITING

Velocity Clinical Research - Cleveland

Beachwood, Ohio, 44122, United States

RECRUITING

Velocity Clinical Research - Cincinnati - Blue Ash

Cincinnati, Ohio, 45242, United States

RECRUITING

Velocity Clinical Research - Medford

Medford, Oregon, 97504, United States

RECRUITING

Velocity Clinical Research - Providence

East Greenwich, Rhode Island, 02818, United States

RECRUITING

Velocity Clinical Research - Anderson

Anderson, South Carolina, 29621, United States

RECRUITING

Velocity Clinical Research - Spartanburg

Spartanburg, South Carolina, 29303, United States

RECRUITING

Holston Medical Group

Kingsport, Tennessee, 37660, United States

RECRUITING

AMR Knoxville, TN

Knoxville, Tennessee, 37909, United States

RECRUITING

CNS Healthcare - Memphis

Memphis, Tennessee, 38119, United States

RECRUITING

Amarillo Medical Specialists LLP

Amarillo, Texas, 79124, United States

RECRUITING

QCR - BioBehavioral Research of Austin

Austin, Texas, 78759, United States

RECRUITING

Zenos Clinical Research

Dallas, Texas, 75230, United States

RECRUITING

Fort Worth Endocrine Research Center

Fort Worth, Texas, 76132, United States

RECRUITING

Epic Clinical Research

Lewisville, Texas, 75057, United States

RECRUITING

Prime Clinical Research - Mansfield - US 287

Mansfield, Texas, 76063, United States

RECRUITING

AMR Norfolk

Norfolk, Virginia, 23502, United States

RECRUITING

Velocity Clinical Research - Spokane

Spokane, Washington, 99218, United States

RECRUITING

Central Study Contacts

Medical Information

CONTACT

6173416777; medicalinfo@vrtx.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: November 21, 2025
• Primary Completion (Estimated): April 6, 2027
• Study Completion (Estimated): April 6, 2027
• Last Updated: April 27, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (65)