RecruitingPhase 3NCT07231419
Evaluation of Efficacy and Safety of Suzetrigine (SUZ) for Pain Associated With Diabetic Peripheral Neuropathy
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
Sponsor
Vertex Pharmaceuticals Incorporated
Enrollment
734 participants
Start Date
Nov 21, 2025
Study Type
INTERVENTIONAL
Conditions
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).
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria4
- 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
Exclusion Criteria3
- 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
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Interventions
DRUGSuzetrigine
Tablets for oral administration
DRUGPlacebo (matched to SUZ)
Placebo matched to SUZ for oral administration.
Locations(75)
View Full Details on ClinicalTrials.gov
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NCT07231419
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