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Evaluation of Efficacy and Safety of Suzetrigine (SUZ) for Pain Associated With Diabetic Peripheral Neuropathy
RecruitingPhase 3
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
Who can join
Ages 18 to 80 · All sexes
Full 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.
About the study
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).
What is being tested
- Suzetrigine (drug)
- Placebo (matched to SUZ) (drug)
Sponsor: Vertex Pharmaceuticals Incorporated · Participants: 734 · Started: Nov 21, 2025
Contact the study team
- Medical Information · Phone: 6173416777
Official record on ClinicalTrials.gov — NCT07231419
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.