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

A Phase 3, Randomized, Double-blind, Placebo- and Active-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

Key Inclusion Criteria:

* Body weight greater than or equal to (≥) 45 kilogram (kg)
* Body mass index (BMI) ≥18.0 to less than (\<) 40.0 kilogram per meter square (kg/m\^2)
* Diagnosis of diabetes mellitus type 1 or type 2 by glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pain in lower extremities due to DPN
* 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
* 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 (SUZ) in participants with pain associated with diabetic peripheral neuropathy (DPN).

What is being tested

• Suzetrigine (drug)
• Placebo (matched to SUZ) (drug)
• Pregabalin (drug)
• Placebo (matched to Pregabalin) (drug)

Sponsor: Vertex Pharmaceuticals Incorporated · Participants: 1,100 · Started: Oct 1, 2024

Contact the study team

• Medical Information · Phone: 617-341-6777

Official record on ClinicalTrials.gov — NCT06628908

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.