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Taking people in United StatesPhase 3

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

Key facts

Who runs it
Vertex Pharmaceuticals Incorporated
Where
Amarillo, Anderson, Asheville, Atlanta, Austin, Baton Rouge, Beachwood, Birmingham, Boca Raton, Boston, Boulder, Brooklyn, Canoga Park, Chattanooga, Cincinnati, Creve Coeur, Dallas, Decatur, DeLand, East Greenwich, East Syracuse, Farmington Hills, Fayetteville, Fort Worth, Glendale, Gulfport, Hallandale, Hazelwood, Huntington Beach, Jacksonville, Jupiter, Kansas City, Kingsport, Knoxville, La Mesa, Lafayette, Las Vegas, Lewisville, Little Rock, Long Beach, Mansfield, Medford, Memphis, Miami Lakes, Mobile, Modesto, Monroe, Morehead City, Naples, New Windsor, Norfolk, Norman, North Charleston, Orlando, Palm Harbor, Palm Springs, Pasadena, Port Saint Lucie, Riverside, Rochester, Rockville, San Antonio, San Bernardino, Savannah, Scottsdale, Spartanburg, Spokane, Tinley Park, Toms River, Viera, Washington D.C., Waterbury, Wheat Ridge, and Winter Park, United StatesSee the 75 sites
Trial code
Status
Recruiting
Phase
Phase 3
People taking part
734 people, planned
Started
21 Nov 2025
Expected to end
6 Apr 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Suzetrigine
  • Placebo (matched to SUZ)
Record updated
20 July 2026

Who can take part

Age
18 years to 80 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Received Journavx within 30 days of study drug dosing
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in United States

  • Amarillo Medical Specialists LLPAmarillo, United StatesTaking people
  • Velocity Clinical Research, AndersonAnderson, United StatesTaking people
  • Asheville Clinical ResearchAsheville, United StatesTaking people
  • Atlanta Center for Medical ResearchAtlanta, United StatesTaking people
  • QCR - BioBehavioral Research of AustinAustin, United StatesTaking people
  • Velocity Clinical Research - Baton RougeBaton Rouge, United StatesTaking people
  • Velocity Clinical Research, ClevelandBeachwood, United StatesTaking people
  • Accel Research - BirminghamBirmingham, United StatesTaking people
  • Central Research Associates, LLCBirmingham, United StatesTaking people
  • Neurology Offices of South Florida PLLCBoca Raton, United StatesTaking people
  • Boston Clinical TrialsBoston, United StatesTaking people
  • Alpine Clinical Research CenterBoulder, United StatesTaking people
  • Brooklyn Clinical ResearchBrooklyn, United StatesTaking people
  • Hope Clinical ResearchCanoga Park, United StatesTaking people
  • M3 Wake Research - ChattanoogaChattanooga, United StatesTaking people
  • Velocity Clinical Research - Cincinnati, Blue AshCincinnati, United StatesTaking people
  • SCLA Management - St. Louis Pain ConsultantsCreve Coeur, United StatesNo longer taking part
  • Zenos Clinical ResearchDallas, United StatesTaking people
  • Accel Research - DecaturDecatur, United StatesTaking people
  • Accel Research - DelandDeLand, United StatesTaking people
  • Velocity Clinical Research, ProvidenceEast Greenwich, United StatesTaking people
  • Velocity Clinical Research, SyracuseEast Syracuse, United StatesTaking people
  • QUEST Research InstituteFarmington Hills, United StatesTaking people
  • Javara Inc./Privia Medical Group - Fayetteville, GAFayetteville, United StatesTaking people
  • Fort Worth Endocrine Research CenterFort Worth, United StatesTaking people
  • Sun City Clinical ResearchGlendale, United StatesTaking people
  • Velocity Clinical Research, GulfportGulfport, United StatesTaking people
  • Velocity Clinical Research, Hallandale BeachHallandale, United StatesTaking people
  • Healthcare Research Network - Hazelwood MOHazelwood, United StatesTaking people
  • Marvel Clinical ResearchHuntington Beach, United StatesTaking people
  • CNS Healthcare - JacksonvilleJacksonville, United StatesTaking people
  • Health Awareness, Inc., JupiterJupiter, United StatesTaking people
  • AMR Kansas CityKansas City, United StatesTaking people
  • Holston Medical Group.Kingsport, United StatesTaking people
  • AMR Knoxville, TNKnoxville, United StatesNo longer taking part
  • Eximia Research-CA, LLCLa Mesa, United StatesTaking people
  • Velocity Clinical Research, LafayetteLafayette, United StatesTaking people
  • M3 Wake Research - Las VegasLas Vegas, United StatesTaking people
  • Epic Clinical ResearchLewisville, United StatesTaking people
  • Lynn Institute of the OzarksLittle Rock, United StatesTaking people
  • Long Beach Research InstituteLong Beach, United StatesTaking people
  • Prime Clinical Research - Mansfield - US 287Mansfield, United StatesTaking people
  • Velocity Clinical Research, MedfordMedford, United StatesTaking people
  • CNS Healthcare - MemphisMemphis, United StatesTaking people
  • 3Sync Research - Miami LakesMiami Lakes, United StatesTaking people
  • AMR MobileMobile, United StatesNo longer taking part
  • Paradigm Clincial Research - ModestoModesto, United StatesTaking people
  • Monroe Biomedical ResearchMonroe, United StatesTaking people
  • West Clinical ResearchMorehead City, United StatesTaking people
  • Aqualane Clinical ResearchNaples, United StatesNo longer taking part
  • Mid Hudson Medical Research, PLLCNew Windsor, United StatesTaking people
  • AMR NorfolkNorfolk, United StatesTaking people
  • Lynn Institute of NormanNorman, United StatesTaking people
  • Coastal Carolina Research CenterNorth Charleston, United StatesTaking people
  • CNS Healthcare OrlandoOrlando, United StatesTaking people
  • Suncoast Clinical Research - Palm HarborPalm Harbor, United StatesNo longer taking part
  • 3Sync Research - Palm SpringsPalm Springs, United StatesTaking people
  • Pasadena Clinical TrialsPasadena, United StatesTaking people
  • Health Awareness, Inc. - Port St. LuciePort Saint Lucie, United StatesTaking people
  • Artemis Institute for Clinical Research RiversideRiverside, United StatesTaking people
  • Rochester Clinical Research - RochesterRochester, United StatesTaking people
  • Velocity Clinical Research, RockvilleRockville, United StatesTaking people
  • Clinical Trials of Texas LLCSan Antonio, United StatesTaking people
  • Velocity Clinical Research, San BernardinoSan Bernardino, United StatesTaking people
  • Velocity Clinical Research - SavannahSavannah, United StatesTaking people
  • Scottsdale Clinical TrialsScottsdale, United StatesTaking people
  • Velocity Clinical Research, SpartanburgSpartanburg, United StatesTaking people
  • Velocity Clinical Research SpokaneSpokane, United StatesTaking people
  • Healthcare Research Network - Flossmoor ILTinley Park, United StatesTaking people
  • CenExel AMRIToms River, United StatesTaking people
  • ClinCloud - VieraViera, United StatesTaking people
  • Velocity Clinical Research, Washington DCWashington D.C., United StatesTaking people
  • Chase Medical ResearchWaterbury, United StatesTaking people
  • Paradigm Clinical Research - Wheat RidgeWheat Ridge, United StatesTaking people
  • Conquest Clinical Research (Winter Park)Winter Park, United StatesTaking people

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

  • Suzetrigine (SUZ)Treatment being tested

    Participants will be randomized to receive SUZ.

    Treatment: Suzetrigine

  • PlaceboPlacebo, for comparison

    Participants will be randomized to receive placebo matched to SUZ.

    Treatment: Placebo (matched to SUZ)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of the Efficacy and Safety of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
Fit questions
Built from NCT07231419, who can take part
Record updated
20 July 2026