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

NCT ID
NCT07231419
Registry status
Recruiting
Study type
Not specified in the registry data
Phase
Phase 3
Sponsor
Vertex Pharmaceuticals Incorporated

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 734 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages
Not specified in the registry data
Sex
Not specified in the registry data
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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.

Study locations

75 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: United States

  • Alabama, United States: 3
  • Arizona, United States: 2
  • Arkansas, United States: 1
  • California, United States: 8
  • Colorado, United States: 2
  • Connecticut, United States: 1
  • District of Columbia, United States: 1
  • Florida, United States: 13
  • Georgia, United States: 4
  • Illinois, United States: 1
  • Louisiana, United States: 2
  • Maryland, United States: 1
  • Massachusetts, United States: 1
  • Michigan, United States: 1
  • Mississippi, United States: 1
  • Missouri, United States: 3
  • Nevada, United States: 1
  • New Jersey, United States: 1
  • New York, United States: 4
  • North Carolina, United States: 3
  • Ohio, United States: 2
  • Oklahoma, United States: 1
  • Oregon, United States: 1
  • Rhode Island, United States: 1
  • South Carolina, United States: 3
  • Tennessee, United States: 4
  • Texas, United States: 7
  • Virginia, United States: 1
  • Washington, United States: 1

Sample of listed locations

  • Accel Research - Birmingham — Birmingham, Alabama, 35216, United States — Site recruitment status not specified in the registry data
  • Central Research Associates, LLC — Birmingham, Alabama, 35205, United States — Site recruitment status not specified in the registry data
  • AMR Mobile — Mobile, Alabama, 36608, United States — Site recruitment status not specified in the registry data
  • Sun City Clinical Research — Glendale, Arizona, 85304, United States — Site recruitment status not specified in the registry data
  • Scottsdale Clinical Trials — Scottsdale, Arizona, 85260, United States — Site recruitment status not specified in the registry data
  • Lynn Institute of the Ozarks — Little Rock, Arkansas, 72204, United States — Site recruitment status not specified in the registry data
  • Hope Clinical Research — Canoga Park, California, 91303, United States — Site recruitment status not specified in the registry data
  • Marvel Clinical Research — Huntington Beach, California, 92647, United States — Site recruitment status not specified in the registry data
  • Eximia Research-CA, LLC — La Mesa, California, 91942, United States — Site recruitment status not specified in the registry data
  • Long Beach Research Institute — Long Beach, California, 90805, United States — Site recruitment status not specified in the registry data
  • Paradigm Clincial Research - Modesto — Modesto, California, 95355, United States — Site recruitment status not specified in the registry data
  • Pasadena Clinical Trials — Pasadena, California, 91101, United States — Site recruitment status not specified in the registry data
  • Artemis Institute for Clinical Research - Riverside — Riverside, California, 92503, United States — Site recruitment status not specified in the registry data
  • Velocity Clinical Research -San Bernardino — San Bernardino, California, 92408, United States — Site recruitment status not specified in the registry data
  • Alpine Clinical Research Center — Boulder, Colorado, 80301, United States — Site recruitment status not specified in the registry data
  • Paradigm Clinical Research - Wheat Ridge — Wheat Ridge, Colorado, 80033, United States — Site recruitment status not specified in the registry data
  • Chase Medical Research — Waterbury, Connecticut, 06708, United States — Site recruitment status not specified in the registry data
  • Velocity Clinical Research - Washington DC — Washington D.C., District of Columbia, 20016, United States — Site recruitment status not specified in the registry data
  • Neurology Offices of South Florida, PLLC — Boca Raton, Florida, 33428, United States — Site recruitment status not specified in the registry data
  • Accel Research - Deland — DeLand, Florida, 32720, United States — Site recruitment status not specified in the registry data
  • Velocity Clinical Research - Hallandale Beach — Hallandale, Florida, 33009, United States — Site recruitment status not specified in the registry data
  • CNS Healthcare - Jacksonville — Jacksonville, Florida, 32256, United States — Site recruitment status not specified in the registry data
  • Health Awareness, Inc. - Jupiter — Jupiter, Florida, 33458, United States — Site recruitment status not specified in the registry data
  • 3Sync Research -Miami Lakes — Miami Lakes, Florida, 33014, United States — Site recruitment status not specified in the registry data
  • Aqualane Clinical Research — Naples, Florida, 34105, United States — Site recruitment status not specified in the registry data

Study details

Start date
November 21, 2025
Primary completion date
April 6, 2027
First posted
November 17, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07231419
Registry last updated
July 20, 2026
QualifiedStudies registry data refreshed
September 21, 2026

View NCT07231419 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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