Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy
A Phase 3, Randomized, Double-blind, Placebo- and Active-Controlled Study of the Efficacy and Safety of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
1 other identifier
interventional
1,100
1 country
76
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2024
Typical duration for phase_3
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2024
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedFirst Posted
Study publicly available on registry
October 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
April 28, 2026
September 1, 2025
2.7 years
September 30, 2024
April 27, 2026
Conditions
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 (2)
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 VX24-548-111)
From Baseline up to Week 12
Change From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12 Compared to Pregabalin
From Baseline up to Week 12
Study Arms (3)
Suzetrigine (SUZ)
EXPERIMENTALParticipants will be randomized to receive SUZ.
Pregabalin
ACTIVE COMPARATORParticipants will be randomized to receive Pregabalin.
Placebo
PLACEBO COMPARATORParticipants will be randomized to receive placebo matched to SUZ and Pregabalin.
Interventions
Placebo matched to Pregabalin for oral administration.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- More than 3 missing daily NPRS scores during the 7-day Baseline Period
- Any sensory abnormality (excluding DPN) as pre-specified in the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (76)
Pinnacle Research Group, LLC
Anniston, Alabama, 36207, United States
Synexus Clinical Research - Birmingham
Birmingham, Alabama, 35211, United States
AMR Daphne, AL
Daphne, Alabama, 36526, United States
Synexus Clinical Research - Phoenix Central
Phoenix, Arizona, 85020, United States
Scottsdale Clinical Trials
Scottsdale, Arizona, 85260, United States
Neuro-Pain Medical Center
Fresno, California, 93710, United States
Long Beach Research Institute
Long Beach, California, 90805, United States
Angel City Research, Inc
Los Angeles, California, 90010, United States
Empire Clinical Research
Pomona, California, 91767, United States
Clinical Trials Research
Sacramento, California, 95821, United States
Velocity Clinical Research, San Bernardino
San Bernardino, California, 92408, United States
SCLA Management - Pain Management and Injury Relief
Thousand Oaks, California, 91320, United States
Diablo Clinical Research (DCR)
Walnut Creek, California, 94598, United States
Velocity Clinical Research - Denver
Englewood, Colorado, 80110, United States
Velocity Clinical Research - Washington DC
Washington D.C., District of Columbia, 20016, United States
Accel Research - Deland
DeLand, Florida, 32720, United States
AMR-Miami
Doral, Florida, 33172, United States
AMR Fort Myers (The Clinical Study Center)
Fort Myers, Florida, 33912, United States
Velocity Clinical Research - Hallandale Beach
Hallandale, Florida, 33009, United States
CNS Healthcare - Jacksonville
Jacksonville, Florida, 32256, United States
Accel Research - St. Petersburg-Largo
Largo, Florida, 33777, United States
Accel Research - Maitland
Maitland, Florida, 32751, United States
Suncoast Research Associates - Miami
Miami, Florida, 33172, United States
3Sync Research - Miami Lakes
Miami Lakes, Florida, 33014, United States
Suncoast Clinical Research - New Port Richey
New Port Richey, Florida, 34652, United States
Synexus Clinical Research - Orlando
Orlando, Florida, 32806, United States
Conquest Clinical Research - Orlando - Neuro
Orlando, Florida, 32832, United States
Conquest Clinical Research - Winter Park
Winter Park, Florida, 32789, United States
Accel Research - Decatur
Decatur, Georgia, 30030, United States
Velocity Clinical Research - Boise
Meridian, Idaho, 83642, United States
Feinberg School of Medicine - Anesthesiology
Chicago, Illinois, 60611, United States
Healthcare Research Network - Flossmoor IL
Flossmoor, Illinois, 604773027, United States
Synexus Clinical Research - Evansville
Evansville, Indiana, 47714, United States
AMR Wichita East, KS (Heartland Research Associates)
Wichita, Kansas, 67207, United States
AMR Lexington
Lexington, Kentucky, 40509, United States
Velocity Clinical Research - Baton Rouge
Baton Rouge, Louisiana, 70809, United States
Tandem Clinical Research- Covington
Covington, Louisiana, 70433, United States
Mass General Brigham - Brigham and Women's Hospital - Main Campus
Boston, Massachusetts, 02115, United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451, United States
Healthcare Research Network - Hazelwood MO
Hazelwood, Missouri, 63042, United States
AMR Kansas City
Kansas City, Missouri, 64114, United States
St. Louis Children's Hospital - Nephrology
St Louis, Missouri, 63110, United States
Synexus Clinical Research - St. Louis
St Louis, Missouri, 63141, United States
Velocity Clinical Research - Norfolk
Norfolk, Nebraska, 68701, United States
Synexus Clinical Research - Las Vegas
Las Vegas, Nevada, 89113, United States
HRI - Hassman Research Institute
Marlton, New Jersey, 08053, United States
Velocity Clinical Research - Albuquerque
Albuquerque, New Mexico, 87107, United States
Albany Medical College
Albany, New York, 12208, United States
Swift Clinical OpCo, Inc
Brooklyn, New York, 11226, United States
Velocity Clinical Research - Syracuse
East Syracuse, New York, 13057, United States
Synexus Clinical Research - New York (DRS)
New York, New York, 10017, United States
Columbia Presbyterian - The Neurological Institute of New York
New York, New York, 10032, United States
West Clinical Research
Morehead City, North Carolina, 28557, United States
Eximia Research - Raleigh
Raleigh, North Carolina, 27607, United States
Carolinas Pain Institute - Winston-Salem Office
Winston-Salem, North Carolina, 27103, United States
Velocity Clinical Research - Cleveland
Beachwood, Ohio, 44122, United States
Synexus Clinical Research - Cincinnati
Cincinnati, Ohio, 45236, United States
META Medical Research Institute
Dayton, Ohio, 45432, United States
Velocity Clinical Research - Grants Pass
Grants Pass, Oregon, 97527, United States
Velocity Clinical Research - Medford
Medford, Oregon, 97504, United States
Suburban Research Associates - Media
Media, Pennsylvania, 19063, United States
Velocity Clinical Research - Providence
East Greenwich, Rhode Island, 02818, United States
Synexus Clinical Research- Anderson
Anderson, South Carolina, 29621, United States
Clinical Trials of South Carolina - Berkeley - Charleston
Charleston, South Carolina, 29406, United States
M3 Wake Research - Charleston
Charleston, South Carolina, 29414, United States
Velocity Clinical Research - Spartanburg
Spartanburg, South Carolina, 29303, United States
AMR Nashville, TN
Nashville, Tennessee, 37203, United States
Zenos Clinical Research
Dallas, Texas, 75230, United States
Synexus Clinical Research - Dallas (DFW) (DRS)
Dallas, Texas, 75234, United States
Be Well Clinical Studies - Austin
Round Rock, Texas, 78681, United States
San Antonio Clinical Trials
San Antonio, Texas, 78240, United States
Velocity Clinical Research - Waco
Waco, Texas, 76710, United States
Velocity Clinical Research - Salt Lake City
West Jordan, Utah, 84088, United States
Kalo Clinical Research - West Valley City
West Valley City, Utah, 84120, United States
Dominion Medical Associates, Inc.
Richmond, Virginia, 23219, United States
Northwest Clinical Research Center (NWCRC)
Bellevue, Washington, 98007, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
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
September 30, 2024
First Posted
October 8, 2024
Study Start
October 1, 2024
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
April 28, 2026
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
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/