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Evaluating Suzetrigine for Pain from 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

Phase 3 Interventional Vertex Pharmaceuticals Incorporated · NCT06628908

This study is testing if a new medication called Suzetrigine can help people with diabetic nerve pain feel better compared to a placebo and a standard treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1100 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorVertex Pharmaceuticals Incorporated Industry-sponsored
Locations76 sites (Anniston, Alabama and 75 other locations)
Trial IDNCT06628908 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy, safety, and tolerability of Suzetrigine in individuals suffering from pain associated with diabetic peripheral neuropathy (DPN). Participants will be randomly assigned to receive either Suzetrigine, a placebo matched to Suzetrigine, Pregabalin, or a placebo matched to Pregabalin. The study will measure pain levels using a numerical pain rating scale (NPRS) and monitor for any adverse effects during the treatment period. The goal is to determine if Suzetrigine can provide significant pain relief compared to the placebo and standard treatment.

Who should consider this trial

Good fit: Ideal candidates include adults with type 1 or type 2 diabetes experiencing moderate to severe bilateral pain in the lower extremities due to DPN.

Not a fit: Patients with other sensory abnormalities or those who have previously participated in a study involving Suzetrigine may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate pain for patients suffering from diabetic peripheral neuropathy.

How similar studies have performed: Previous studies have shown promise in treating diabetic peripheral neuropathic pain with similar approaches, but the efficacy of Suzetrigine specifically is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Body weight greater than or equal to (≥) 45 kilogram (kg)
* Body mass index (BMI) ≥18.0 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.

Where this trial is running

Anniston, Alabama and 75 other locations

+26 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 2026-06-13 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.