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NCT Number: NCT06628908

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

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).

Recruiting

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Key information

Conditions

Diabetic Peripheral Neuropathic Pain

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pinnacle Research Group, LLC, Anniston, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Suzetrigine

Drug

Tablets for oral administration.

Other names: VX-548, SUZ

Placebo (matched to SUZ)

Drug

Placebo matched to SUZ for oral administration.

Pregabalin

Drug

Capsules for oral administration.

Placebo (matched to pregabalin)

Drug

Placebo matched to Pregabalin for oral administration.

Primary outcomes

  1. Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 Compared to Placebo

    Time frame: From Baseline up to Week 12

Secondary outcomes

  1. Change From Baseline in the Medical Outcomes Study 36-item Short-form Health Status (SF 36v2) Physical Component Summary (PCS) Score at Week 12 Compared to Placebo (pooled with data from Study VX24-548-111)

    Time frame: From Baseline up to Week 12

  2. Change From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12 Compared to Pregabalin

    Time frame: From Baseline up to Week 12

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Information

CONTACT

[email protected]

617-341-6777

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 8, 2024
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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