NCT06628908

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,100 (estimated)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Diabetic Peripheral Neuropathic Pain

Interventions

Type	Name	Description
DRUG	Suzetrigine	Tablets for oral administration.
DRUG	Placebo (matched to SUZ)	Placebo matched to SUZ for oral administration.
DRUG	Pregabalin	Capsules for oral administration.
DRUG	Placebo (matched to Pregabalin)	Placebo matched to Pregabalin for oral administration.

Timeline

• Start date: 2024-10-01
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2024-10-08
• Last updated: 2026-03-31

Locations

76 sites across 1 country: United States

Regulatory

• FDA-regulated drug study