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

Last updated: May 18, 2026
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Suzetrigine

Placebo (matched to SUZ)

Clinical Study ID

NCT07231419
VX24-548-111
  • Ages 18-80
  • All Genders

Study 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 Criteria

Inclusion

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 forat least 1 year

  • Weekly average of daily NPRS score ≥4 and less than or equal to (≤) 9 with limitedvariation in the 7-day Baseline Period

Exclusion

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.

Study Design

Total Participants: 734
Treatment Group(s): 2
Primary Treatment: Suzetrigine
Phase: 3
Study Start date:
November 21, 2025
Estimated Completion Date:
April 06, 2027

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