Diabetic Peripheral Neuropathic PainPhase 3NCT07231419
Evaluation of Efficacy and Safety of Suzetrigine (SUZ) for Pain Associated With Diabetic Peripheral Neuropathy
A Phase 3 study testing Suzetrigine in people with Diabetic Peripheral Neuropathic Pain, run by Vertex Pharmaceuticals Incorporated at 75 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain
- What is being tested?
- Suzetrigine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 734 participants
- Where
- 75 sitesUnited States
- Study dates
- 21 Nov 2025to 6 Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
75 sites in 1 country. Contact the study team or a site near you to ask about taking part.
75 sites in 1 country
United States75 sites, 70 recruiting
- Recruiting
Amarillo Medical Specialists LLP
Amarillo, Texas, 79124
- Recruiting
Velocity Clinical Research - Anderson
Anderson, South Carolina, 29621
- Recruiting
Asheville Clinical Research
Asheville, North Carolina, 28803
- Recruiting
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
- Recruiting
QCR - BioBehavioral Research of Austin
Austin, Texas, 78759
- Recruiting
Velocity Clinical Research - Baton Rouge
Baton Rouge, Louisiana, 70809
- Recruiting
Velocity Clinical Research - Cleveland
Beachwood, Ohio, 44122
- Recruiting
Central Research Associates, LLC
Birmingham, Alabama, 35205
- Recruiting
Accel Research - Birmingham
Birmingham, Alabama, 35216
- Recruiting
Neurology Offices of South Florida, PLLC
Boca Raton, Florida, 33428
- Recruiting
Boston Clinical Trials
Boston, Massachusetts, 02131
- Recruiting
Alpine Clinical Research Center
Boulder, Colorado, 80301
- Recruiting
Brooklyn Clinical Research
Brooklyn, New York, 11226
- Recruiting
Hope Clinical Research
Canoga Park, California, 91303
- Recruiting
M3 Wake Research - Chattanooga
Chattanooga, Tennessee, 37421
- Recruiting
Velocity Clinical Research - Cincinnati - Blue Ash
Cincinnati, Ohio, 45242
- Completed
SCLA Management - St. Louis Pain Consultants
Creve Coeur, Missouri, 63141
- Recruiting
Zenos Clinical Research
Dallas, Texas, 75230
- Recruiting
Accel Research - Decatur
Decatur, Georgia, 30030
- Recruiting
Accel Research - Deland
DeLand, Florida, 32720
- Recruiting
Velocity Clinical Research - Providence
East Greenwich, Rhode Island, 02818
- Recruiting
Velocity Clinical Research - Syracuse
East Syracuse, New York, 13057
- Recruiting
Quest Research Institute
Farmington Hills, Michigan, 48334
- Recruiting
Javara Inc./Privia Medical Group - Fayetteville, GA
Fayetteville, Georgia, 30214
- Recruiting
Fort Worth Endocrine Research Center
Fort Worth, Texas, 76132
- Recruiting
Sun City Clinical Research
Glendale, Arizona, 85304
- Recruiting
Velocity Clinical Research - Gulfport
Gulfport, Mississippi, 39503
- Recruiting
Velocity Clinical Research - Hallandale Beach
Hallandale, Florida, 33009
- Recruiting
Healthcare Research Network - Hazelwood MO
Hazelwood, Missouri, 63042
- Recruiting
Marvel Clinical Research
Huntington Beach, California, 92647
- Recruiting
CNS Healthcare - Jacksonville
Jacksonville, Florida, 32256
- Recruiting
Health Awareness, Inc. - Jupiter
Jupiter, Florida, 33458
- Recruiting
AMR Kansas City
Kansas City, Missouri, 64114
- Recruiting
Holston Medical Group
Kingsport, Tennessee, 37660
- Completed
AMR Knoxville, TN
Knoxville, Tennessee, 37909
- Recruiting
Eximia Research-CA, LLC
La Mesa, California, 91942
- Recruiting
Velocity Clinical Research - Lafayette
Lafayette, Louisiana, 70508
- Recruiting
M3 Wake Research - Las Vegas
Las Vegas, Nevada, 89106
- Recruiting
Epic Clinical Research
Lewisville, Texas, 75057
- Recruiting
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72204
- Recruiting
Long Beach Research Institute
Long Beach, California, 90805
- Recruiting
Prime Clinical Research - Mansfield - US 287
Mansfield, Texas, 76063
- Recruiting
Velocity Clinical Research - Medford
Medford, Oregon, 97504
- Recruiting
CNS Healthcare - Memphis
Memphis, Tennessee, 38119
- Recruiting
3Sync Research -Miami Lakes
Miami Lakes, Florida, 33014
- Completed
AMR Mobile
Mobile, Alabama, 36608
- Recruiting
Paradigm Clincial Research - Modesto
Modesto, California, 95355
- Recruiting
Monroe Biomedical research
Monroe, North Carolina, 28112
- Recruiting
West Clinical Research
Morehead City, North Carolina, 28557
- Completed
Aqualane Clinical Research
Naples, Florida, 34105
- Recruiting
Mid Hudson Medical Research, PLLC
New Windsor, New York, 12553
- Recruiting
AMR Norfolk
Norfolk, Virginia, 23502
- Recruiting
Lynn Institute of Norman
Norman, Oklahoma, 73072
- Recruiting
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
- Recruiting
CNS Healthcare - Orlando
Orlando, Florida, 32806
- Completed
Suncoast Clinical Research - Palm Harbor
Palm Harbor, Florida, 34684
- Recruiting
3Sync Research - Palm Springs
Palm Springs, Florida, 33461
- Recruiting
Pasadena Clinical Trials
Pasadena, California, 91101
- Recruiting
Health Awareness, Inc. - Port St. Lucie
Port Saint Lucie, Florida, 34952
- Recruiting
Artemis Institute for Clinical Research - Riverside
Riverside, California, 92503
- Recruiting
Rochester Clinical Research - Rochester
Rochester, New York, 14609
- Recruiting
Velocity Clinical Research - Rockville
Rockville, Maryland, 20854
- Recruiting
Clinical Trials of Texas, LLC
San Antonio, Texas, 78229
- Recruiting
Velocity Clinical Research -San Bernardino
San Bernardino, California, 92408
- Recruiting
Velocity Clinical Research - Savannah
Savannah, Georgia, 31406
- Recruiting
Scottsdale Clinical Trials
Scottsdale, Arizona, 85260
- Recruiting
Velocity Clinical Research - Spartanburg
Spartanburg, South Carolina, 29303
- Recruiting
Velocity Clinical Research - Spokane
Spokane, Washington, 99218
- Recruiting
Healthcare Research Network - Flossmoor IL
Tinley Park, Illinois, 60477
- Recruiting
CenExel AMRI
Toms River, New Jersey, 08755
- Recruiting
ClinCloud - Viera
Viera, Florida, 32940
- Recruiting
Velocity Clinical Research - Washington DC
Washington D.C., District of Columbia, 20016
- Recruiting
Chase Medical Research
Waterbury, Connecticut, 06708
- Recruiting
Paradigm Clinical Research - Wheat Ridge
Wheat Ridge, Colorado, 80033
- Recruiting
Conquest Clinical Research - Winter Park
Winter Park, Florida, 32789
About this study
Official title: A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of the Efficacy and Safety of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
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).
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Being tested
- Suzetrigine, Placebo (matched to SUZ)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuzetrigineDrug
Also called VX-548, SUZ
Tablets for oral administration
Placebo (matched to SUZ)Drug
Placebo matched to SUZ for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Suzetrigine (SUZ) | Experimental | Participants will be randomized to receive SUZ. Receives: Drug: Suzetrigine |
| Placebo | Placebo comparator | Participants will be randomized to receive placebo matched to SUZ. Receives: Drug: Placebo (matched to SUZ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 Compared to Placebo
Measured: 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 VX24-548-110)
Measured: From Baseline up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start21 Nov 2025
- Primary completion6 Apr 2027 (estimated)
- Study completion6 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 734 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231419
- Sponsor's protocol ID
- VX24-548-111
- Status last verified
- Jul 2026
- First submitted
- 13 Nov 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of the Efficacy and Safety of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07231419
- Acronym / sponsor ID
- VX24-548-111
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 734 participants (estimated)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- 6 Apr 2027 (estimated)
- Study completion
- 6 Apr 2027 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suzetrigine (SUZ) | Experimental | Drug: SuzetrigineParticipants will be randomized to receive SUZ. |
| Placebo | Placebo comparator | Drug: Placebo (matched to SUZ)Participants will be randomized to receive placebo matched to SUZ. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SuzetrigineAlso: VX-548, SUZTablets for oral administration | Drug | Suzetrigine (SUZ) |
| Placebo (matched to SUZ)Placebo matched to SUZ for oral administration. | Drug | Placebo |
Primary outcome
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
1 secondary outcome
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 VX24-548-110)
Time frame: From Baseline up to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No. Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
75 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Suzetrigine in people with Diabetic Peripheral Neuropathic Pain, run by Vertex Pharmaceuticals Incorporated at 75 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Information (6173416777, medicalinfo@vrtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.