Home › Trials › NCT07231419

Suzetrigine for pain from 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

Phase 3 Interventional Vertex Pharmaceuticals Incorporated · NCT07231419

This trial will test whether Suzetrigine reduces pain in adults with diabetic peripheral neuropathy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment734 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorVertex Pharmaceuticals Incorporated Industry-sponsored
Locations66 sites (Birmingham, Alabama and 65 other locations)
Trial IDNCT07231419 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial compares Suzetrigine with a matching placebo in adults who have had painful diabetic peripheral neuropathy for at least one year. Eligible participants have type 1 or type 2 diabetes with HbA1c ≤9%, meet specified weight and BMI limits, and report a weekly average pain score of 4–9 on the NPRS during a baseline period. Participants will be assigned to receive Suzetrigine or placebo and will be followed for changes in pain as well as safety and tolerability. The trial is sponsored by Vertex Pharmaceuticals and will enroll participants at clinical sites and a mobile unit in Alabama.

Who should consider this trial

Good fit: Adults with type 1 or type 2 diabetes who have bilateral lower‑extremity neuropathic pain for at least one year, a baseline weekly average pain score ≥4, HbA1c ≤9%, and who meet the study's weight and BMI requirements are ideal candidates.

Not a fit: Patients with other non‑DPN sensory abnormalities, recent receipt of Journavx within 30 days, inability to provide the required baseline pain reporting, or who fall outside the protocol's weight/BMI or HbA1c limits may not qualify and are unlikely to benefit from participation.

Why it matters

Potential benefit: If effective, Suzetrigine could reduce neuropathic pain and improve daily functioning for people with diabetic peripheral neuropathy.

How similar studies have performed: Approved drugs like duloxetine and pregabalin have shown benefit for diabetic neuropathic pain, but Suzetrigine is a novel investigational agent being tested in Phase 3 with limited public Phase 3 data available.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 65 other locations

+16 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetic Peripheral Neuropathic Pain
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.