Suzetrigine for pain from diabetic peripheral neuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Central Research Associates, LLC
  Birmingham, Alabama, United States Recruiting
• Accel Research - Birmingham
  Birmingham, Alabama, United States Recruiting
• Sun City Clinical Research
  Glendale, Arizona, United States Recruiting
• Scottsdale Clinical Trials
  Scottsdale, Arizona, United States Recruiting
• Lynn Institute of the Ozarks
  Little Rock, Arkansas, United States Recruiting
• Hope Clinical Research
  Canoga Park, California, United States Recruiting

+25 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Medical Information
• Email: medicalinfo@vrtx.com
• Phone: 6173416777

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• HRS-2129 for diabetic peripheral neuropathic pain

  This trial will test whether HRS-2129 tablets reduce pain in adults with diabetic peripheral neuropathy compared with placebo.

  Recruiting at 2 sites Phase 1 Shandong Suncadia Medicine Co., Ltd. · Beijing, Beijing Municipality and 1 other locations · NCT07377721

• LY4065967 for diabetic peripheral neuropathic pain (part of a chronic pain master protocol)

  This trial tests whether LY4065967 can safely reduce pain in adults with diabetic peripheral neuropathic pain.

  Recruiting at 36 sites Phase 2 Eli Lilly and Company · Birmingham, Alabama and 35 other locations · NCT07285018

• Evaluating Suzetrigine for Pain from Diabetic Peripheral Neuropathy

  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.

  Recruiting at 58 sites Phase 3 Vertex Pharmaceuticals Incorporated · Anniston, Alabama and 75 other locations · NCT06628908

• Evaluating VX-993 for pain from diabetic nerve damage

  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.

  Recruiting at 22 sites Phase 2 Vertex Pharmaceuticals Incorporated · Cullman, Alabama and 46 other locations · NCT06619860

• Assessing a new spray treatment for diabetic nerve pain

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  Recruiting Phase 1 Zhejiang Hanmai Pharmaceutical Technology Co., Ltd. · Fredericksburg, Texas · NCT06361108

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.