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RecruitingPhase 3

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

Vertex Pharmaceuticals Incorporated · NCT07231419

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–80 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
734
US sites recruiting
70
Study start
November 21, 2025
Record last updated
July 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Suzetrigine; Placebo (matched to SUZ)

Conditions: Diabetic Peripheral Neuropathic Pain

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

+ 10 more on the official record.

Study contacts (from the official record)

  • Medical Information · 6173416777 · medicalinfo@vrtx.com
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Evaluation of Efficacy and Safety of Suzetrigine (SUZ) for Pain… (NCT07231419) | Bored Studies