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

NCT07231419 · tracked via the Priya Life Science USA tracker

Sponsor

Vertex Pharmaceuticals Incorporated

Phase

Phase 3

Started

2025-11-21

Last updated

2026-07-20

Condition(s) studied

Diabetic Peripheral Neuropathic Pain

Investigational drug(s) / intervention(s)

SuzetriginePlacebo (matched to SUZ)

Suzetrigine: Tablets for oral administration

Placebo (matched to SUZ): Placebo matched to SUZ for oral administration.

Study 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

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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.

Primary outcome measure(s)

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

Trial sites (75)

Facility	City	Region	Status
Central Research Associates, LLC	Birmingham	Alabama	Recruiting
Accel Research - Birmingham	Birmingham	Alabama	Recruiting
AMR Mobile	Mobile	Alabama	Completed
Sun City Clinical Research	Glendale	Arizona	Recruiting
Scottsdale Clinical Trials	Scottsdale	Arizona	Recruiting
Lynn Institute of the Ozarks	Little Rock	Arkansas	Recruiting
Hope Clinical Research	Canoga Park	California	Recruiting
Marvel Clinical Research	Huntington Beach	California	Recruiting
Eximia Research-CA, LLC	La Mesa	California	Recruiting
Long Beach Research Institute	Long Beach	California	Recruiting
Paradigm Clincial Research - Modesto	Modesto	California	Recruiting
Pasadena Clinical Trials	Pasadena	California	Recruiting
Artemis Institute for Clinical Research - Riverside	Riverside	California	Recruiting
Velocity Clinical Research -San Bernardino	San Bernardino	California	Recruiting
Alpine Clinical Research Center	Boulder	Colorado	Recruiting
Paradigm Clinical Research - Wheat Ridge	Wheat Ridge	Colorado	Recruiting
Chase Medical Research	Waterbury	Connecticut	Recruiting
Velocity Clinical Research - Washington DC	Washington D.C.	District of Columbia	Recruiting
Neurology Offices of South Florida, PLLC	Boca Raton	Florida	Recruiting
Accel Research - Deland	DeLand	Florida	Recruiting
Velocity Clinical Research - Hallandale Beach	Hallandale	Florida	Recruiting
CNS Healthcare - Jacksonville	Jacksonville	Florida	Recruiting
Health Awareness, Inc. - Jupiter	Jupiter	Florida	Recruiting
3Sync Research -Miami Lakes	Miami Lakes	Florida	Recruiting
Aqualane Clinical Research	Naples	Florida	Completed
CNS Healthcare - Orlando	Orlando	Florida	Recruiting
Suncoast Clinical Research - Palm Harbor	Palm Harbor	Florida	Completed
3Sync Research - Palm Springs	Palm Springs	Florida	Recruiting
Health Awareness, Inc. - Port St. Lucie	Port Saint Lucie	Florida	Recruiting
ClinCloud - Viera	Viera	Florida	Recruiting
Conquest Clinical Research - Winter Park	Winter Park	Florida	Recruiting
Atlanta Center for Medical Research	Atlanta	Georgia	Recruiting
Accel Research - Decatur	Decatur	Georgia	Recruiting
Javara Inc./Privia Medical Group - Fayetteville, GA	Fayetteville	Georgia	Recruiting
Velocity Clinical Research - Savannah	Savannah	Georgia	Recruiting
Healthcare Research Network - Flossmoor IL	Tinley Park	Illinois	Recruiting
Velocity Clinical Research - Baton Rouge	Baton Rouge	Louisiana	Recruiting
Velocity Clinical Research - Lafayette	Lafayette	Louisiana	Recruiting
Velocity Clinical Research - Rockville	Rockville	Maryland	Recruiting
Boston Clinical Trials	Boston	Massachusetts	Recruiting

+ 35 more sites — see the full list on the official registry below.

More Vertex Pharmaceuticals Incorporated trials in the USA

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A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy Active, not recruiting

A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF) Active, not recruiting

Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy Recruiting

Other trials for the same condition

Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy Recruiting

MAD Study to Assess the Safety, Tolerability, PKs and Efficacy of YJ001 for Spray Use in Patients With DPNP Recruiting

A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain Recruiting

Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN) Active, not recruiting

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

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07231419 on ClinicalTrials.gov ↗ ← All trials in the USA