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Evaluating VX-993 for pain from diabetic nerve damage

A Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of Oral VX-993 in Subjects With Pain Associated With Diabetic Peripheral Neuropathy

Phase 2 Interventional Vertex Pharmaceuticals Incorporated · NCT06619860

This study is testing if a new medication called VX-993 can help people with diabetes who have been dealing with pain in their legs and feet from nerve damage feel better compared to a standard treatment and a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorVertex Pharmaceuticals Incorporated Industry-sponsored
Locations47 sites (Cullman, Alabama and 46 other locations)
Trial IDNCT06619860 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy, safety, and tolerability of VX-993 in individuals suffering from pain associated with Diabetic Peripheral Neuropathy (DPN). Participants will receive either VX-993, Pregabalin, or placebos matched to these treatments. The study will focus on patients diagnosed with diabetes who have experienced bilateral pain in their lower extremities due to DPN for at least one year. The trial is designed to determine how well VX-993 alleviates pain compared to existing treatments and placebos.

Who should consider this trial

Good fit: Ideal candidates are individuals with type 1 or type 2 diabetes and bilateral pain in the lower extremities due to DPN for at least one year.

Not a fit: Patients with painful neuropathy from causes other than DPN or those with recent serious cardiovascular events may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for managing pain associated with diabetic peripheral neuropathy.

How similar studies have performed: Other studies have explored treatments for diabetic neuropathic pain, but the specific approach with VX-993 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Diagnosis of diabetes mellitus type 1 or type 2 with

  * Glycosylated hemoglobin A1c (HbA1c) less than or equal to (≤) 9% and
  * Presence of bilateral pain in lower extremities due to DPN (defined as a symmetric, length-dependent sensory or sensorimotor polyneuropathy) for at least 1 year

Key Exclusion Criteria:

* Painful neuropathy other than DPN
* History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
* History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months

Other protocol defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Cullman, Alabama and 46 other locations

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 2026-06-15 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.