NCT07231419 Evaluation of Efficacy and Safety of Suzetrigine (SUZ) for Pain Associated With Diabetic Peripheral Neuropathy
| NCT ID | NCT07231419 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Vertex Pharmaceuticals Incorporated |
| Condition | Diabetic Peripheral Neuropathic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 734 participants |
| Start Date | 2025-11-21 |
| Primary Completion | 2027-04-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 734 participants in total. It began in 2025-11-21 with a primary completion date of 2027-04-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07231419 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Diabetic Peripheral Neuropathic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07231419 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 734 participants.
Is NCT07231419 currently recruiting?
Yes, NCT07231419 is actively recruiting participants. Contact the research team at medicalinfo@vrtx.com for enrollment information.
Where is the NCT07231419 trial being conducted?
This trial is being conducted at Birmingham, United States, Birmingham, United States, Mobile, United States, Glendale, United States and 11 additional locations.
Who is sponsoring the NCT07231419 clinical trial?
NCT07231419 is sponsored by Vertex Pharmaceuticals Incorporated. The trial plans to enroll 734 participants.