Evaluation of Efficacy and Safety of Suzetrigine (SUZ) for Pain Associated With Diabetic Peripheral Neuropathy
NCT ID: NCT07231419
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
734 participants
INTERVENTIONAL
2025-11-21
2027-04-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Suzetrigine (SUZ)
Participants will be randomized to receive SUZ.
Suzetrigine
Tablets for oral administration
Placebo
Participants will be randomized to receive placebo matched to SUZ.
Placebo (matched to SUZ)
Placebo matched to SUZ for oral administration.
Interventions
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Suzetrigine
Tablets for oral administration
Placebo (matched to SUZ)
Placebo matched to SUZ for oral administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Received Journavx within 30 days of study drug dosing
* Any sensory abnormality (excluding DPN) as pre-specified in the protocol
18 Years
80 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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Velocity Clinical Research -San Bernardino
San Bernardino, California, United States
Velocity Clinical Research - Hallandale Beach
Hallandale, Florida, United States
CNS Healthcare - Jacksonville
Jacksonville, Florida, United States
Health Awareness, Inc. - Jupiter
Jupiter, Florida, United States
3Sync Research -Miami Lakes
Miami Lakes, Florida, United States
Accel Research - Decatur
Decatur, Georgia, United States
Healthcare Research Network - Flossmoor IL
Tinley Park, Illinois, United States
Healthcare Research Network - Hazelwood MO
Hazelwood, Missouri, United States
AMR Kansas City
Kansas City, Missouri, United States
Velocity Clinical Research - Cleveland
Beachwood, Ohio, United States
Velocity Clinical Research - Medford
Medford, Oregon, United States
Velocity Clinical Research - Providence
East Greenwich, Rhode Island, United States
Zenos Clinical Research
Dallas, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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VX24-548-111
Identifier Type: -
Identifier Source: org_study_id
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