Diabetic Peripheral NeuropathyPhase 2NCT05660538

Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)

A Phase 2 study testing Suzetrigine and Pregabalin in people with Diabetic Peripheral Neuropathy, run by Vertex Pharmaceuticals Incorporated at 50 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating Painful DPN. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Diabetic Peripheral Neuropathy
What is being tested?: Suzetrigine and Pregabalin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 194 participants
Where: 50 sitesUnited States
Study dates: 20 Dec 2022to 25 Oct 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Diagnosis of diabetes mellitus type 1 or type 2 with
Glycosylated hemoglobin A1c (HbA1c) ≤9%; and
Presence of bilateral pain in lower extremities due to DPN for at least 1 year

Who cannot join

Painful neuropathy other than DPN
History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months
Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

50 sites in 1 country.

City, postcode or hospital

50 sites in 1 country

United States50 sites

Synexus Clinical Research- Anderson
Anderson, South Carolina, 29621
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
Velocity Clinical Research - Banning
Banning, California, 92220
Inquest Clinical Research
Baytown, Texas, 77521
Northwest Clinical Research Center (NWCRC)
Bellevue, Washington, 98007-4209
Hassman Research Institute
Berlin, New Jersey, 08009
Synexus Clinical Research US - Birmingham
Birmingham, Alabama, 35211
Brigham and Women's Hospital (BWH) - Translational Pain Research
Boston, Massachusetts, 02115
Clinical Trials of South Carolina - Charleston
Charleston, South Carolina, 29406
Synexus - Cincinnati
Cincinnati, Ohio, 45236
StudyMetrix Research, LLC
City of Saint Peters, Missouri, 63303-3041
Velocity Clinical Research - Cleveland
Cleveland, Ohio, 44122
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80918
Synexus - Dallas
Dallas, Texas, 75234-7858
Revival Research Institute
Dearborn, Michigan, 48126
Accel Research Sites - Neurostudies
Decatur, Georgia, 30030
Velocity Clinical Research - Providence
East Greenwich, Rhode Island, 02818
AMR El Dorado
El Dorado, Kansas, 67042
Synexus Clinical Research - Evansville
Evansville, Indiana, 47714
Carolina Institute for Clinical Research
Fayetteville, North Carolina, 28303
Fleming Island Center for Clinical Research
Fleming Island, Florida, 32003
Healthcare Research Network - Chicago
Flossmoor, Illinois, 60422
AMR Fort Myers (The Clinical Study Center)
Fort Myers, Florida, 33912
Triad Clinical Trials
Greensboro, North Carolina, 27410
Velocity Clinical Research - Hallandale Beach
Hallandale, Florida, 33009-4427
Healthcare Research Network - Hazelwood
Hazelwood, Missouri, 63042
Synexus Clinical Research - Henderson
Henderson, Nevada, 89052
Westside Center for Clinical Research
Jacksonville, Florida, 32205
AMR Kansas City
Kansas City, Missouri, 64114-4866
Accel Research Sites - Tampa
Largo, Florida, 33777
Long Beach Clinical Trials Services, Inc.
Long Beach, California, 90806
Accel Research Sites - Maitland
Maitland, Florida, 32751
Velocity Clinical Research - Medford
Medford, Oregon, 97504
Velocity Clinical Research - Boise (Advanced Clinical Research)
Meridian, Idaho, 83642
Suncoast Research Associates
Miami, Florida, 33137
Clinical Trials of America, LLC
Monroe, Louisiana, 71201
Synexus Clinical Research- New York
New York, New York, 10017
AMR Newton
Newton, Kansas, 67114
Boston Neuro Research Center, LLC
North Dartmouth, Massachusetts, 02747
South Carolina Clinical Research
Orangeburg, South Carolina, 29118
Synexus - Orlando
Orlando, Florida, 32806-1041
Synexus Clinical Research US - Phoenix West
Phoenix, Arizona, 85020
Wasatch Clinical Research
Salt Lake City, Utah, 84107
Diabetes & Glandular Disease Clinic, P.A
San Antonio, Texas, 78229-4801
Synexus Clinical Research US - St. Louis
St Louis, Missouri, 63141
Synexus - The Villages
The Villages, Florida, 32162-7116
University Clinical Investigators
Tustin, California, 92780
Boston PainCare Center
Waltham, Massachusetts, 02451
AMR Wichita East, KS
Wichita, Kansas, 67207
The Center for Clinical Research
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of VX-548 in Subjects With Painful Diabetic Peripheral Neuropathy

The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating Painful DPN.

Conditions: Diabetic Peripheral Neuropathy
Being tested: Suzetrigine, Pregabalin, Placebo (matched to SUZ), Placebo (matched to pregabalin)

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.
PregabalinDrug
Capsules for oral administration.
Placebo (matched to SUZ)Drug
Placebo matched to SUZ for oral administration.
Placebo (matched to pregabalin)Drug
Placebo matched to pregabalin for oral administration.

Study groups in NCT05660538
Study group	Role	What they receive
Pregabalin	Active comparator	Participants received Pregabalin 100 mg 3 times per day (tid) for 12 weeks Receives: Drug: Pregabalin; Drug: Placebo (matched to SUZ)
Suzetrigine (SUZ): Low Dose	Experimental	Participants received SUZ 23 mg tablet once daily (qd) for 12 weeks. Receives: Drug: Suzetrigine; Drug: Placebo (matched to pregabalin)
Suzetrigine (SUZ): Mid Dose	Experimental	Participants received SUZ 46 mg tablet qd for 12 weeks. Receives: Drug: Suzetrigine; Drug: Placebo (matched to pregabalin)
Suzetrigine (SUZ): High Dose	Experimental	Participants received SUZ 69 mg tablet qd for 12 weeks. Receives: Drug: Suzetrigine; Drug: Placebo (matched to pregabalin)

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 a Numeric Pain Rating Scale (NPRS)
Change from baseline in the weekly mean of the daily Numeric Pain Rating Scale (NPRS) score assessing average pain intensity in the last 24 hours. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.
Measured: Baseline, At Week 12

Secondary outcomes (6)

Change From Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS) Score
Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) score, which asks participants to describe how pain interfered with the participant's sleep. Response options for the DSIS range from 0 (none) to 10 (severe).
Measured: Baseline, At Week 12
Percentage of Participants With Greater Than or Equal to (≥) 30 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS
Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.
The percentage of participants with ≥30% reduction from baseline in the weekly average NPRS score at Week 12 was reported.
Measured: Baseline, At Week 12
Percentage of Participants With ≥50 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS
Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.The percentage of participants with ≥50% reduction from baseline in the weekly average NPRS score at Week 12 was reported.
Measured: Baseline, At Week 12
Percentage of Participants With ≥70 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS
Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.
The percentage of participants with ≥70% reduction from baseline in the weekly average NPRS score at Week 12 was reported.
Measured: Baseline, At Week 12
Percentage of Participants Categorized as "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Assessment
PGIC is an instrument that measures change in participants' overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Measured: Baseline, At Week 12
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Day 1 up to Week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Dec 202225 Oct 2023

First posted21 Dec 2022
Study start20 Dec 2022
Primary completion12 Oct 2023
Study completion25 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetic Peripheral NeuropathyStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 194 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05660538
Sponsor's protocol ID: VX21-548-103
Status last verified: Jun 2025
First submitted: 13 Dec 2022
Last updated: 1 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
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/independent-research/clinical-trial-data-sharing

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
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Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy
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All Diabetic Peripheral Neuropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of VX-548 in Subjects With Painful Diabetic Peripheral Neuropathy
ClinicalTrials.gov ID: NCT05660538
Acronym / sponsor ID: VX21-548-103
Conditions: Diabetic Peripheral Neuropathy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 194 participants (actual)
Lead sponsor: Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
Study start: 20 Dec 2022 (actual)
Primary completion: 12 Oct 2023 (actual)
Study completion: 25 Oct 2023 (actual)
First posted: 21 Dec 2022 (actual)
Results: Posted 1 Jul 2025

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 and safety of VX-548 doses in treating Painful DPN.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Pregabalin	Active comparator	Drug: Pregabalin, Drug: Placebo (matched to SUZ)Participants received Pregabalin 100 mg 3 times per day (tid) for 12 weeks
Suzetrigine (SUZ): Low Dose	Experimental	Drug: Suzetrigine, Drug: Placebo (matched to pregabalin)Participants received SUZ 23 mg tablet once daily (qd) for 12 weeks.
Suzetrigine (SUZ): Mid Dose	Experimental	Drug: Suzetrigine, Drug: Placebo (matched to pregabalin)Participants received SUZ 46 mg tablet qd for 12 weeks.
Suzetrigine (SUZ): High Dose	Experimental	Drug: Suzetrigine, Drug: Placebo (matched to pregabalin)Participants received SUZ 69 mg tablet qd for 12 weeks.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosis of diabetes mellitus type 1 or type 2 with

Key exclusion criteria (4 listed)

Painful neuropathy other than DPN
History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months
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): High Dose, Suzetrigine (SUZ): Low Dose, Suzetrigine (SUZ): Mid Dose
PregabalinCapsules for oral administration.	Drug	Pregabalin
Placebo (matched to SUZ)Placebo matched to SUZ for oral administration.	Drug	Pregabalin
Placebo (matched to pregabalin)Placebo matched to pregabalin for oral administration.	Drug	Suzetrigine (SUZ): High Dose, Suzetrigine (SUZ): Low Dose, Suzetrigine (SUZ): Mid Dose

Primary outcome

Change From Baseline in the Weekly Average of Daily Pain Intensity on a Numeric Pain Rating Scale (NPRS)
Time frame: Baseline, At Week 12
Change from baseline in the weekly mean of the daily Numeric Pain Rating Scale (NPRS) score assessing average pain intensity in the last 24 hours. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.

6 secondary outcomes

Change From Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS) Score
Time frame: Baseline, At Week 12
Percentage of Participants With Greater Than or Equal to (≥) 30 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS
Time frame: Baseline, At Week 12
Percentage of Participants With ≥50 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS
Time frame: Baseline, At Week 12
Percentage of Participants With ≥70 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS
Time frame: Baseline, At Week 12
Percentage of Participants Categorized as "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Assessment
Time frame: Baseline, At Week 12
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 up to Week 14

Results and safety

Results posted to the registry on 1 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pregabalin	55	46
Suzetrigine (SUZ): Low Dose	28	24
Suzetrigine (SUZ): Mid Dose	55	46
Suzetrigine (SUZ): High Dose	56	47

Primary outcome: Change From Baseline in the Weekly Average of Daily Pain Intensity on a Numeric Pain Rating Scale (NPRS)

Time frame: Baseline, At Week 12. Least squares mean (95% Confidence Interval). Unit: units on a scale

Measure	Pregabalin n = 47	Suzetrigine (SUZ): Low Dose n = 24	Suzetrigine (SUZ): Mid Dose n = 48	Suzetrigine (SUZ): High Dose n = 48
Value	-2.09 (-2.65 to -1.52)	-2.18 (-2.94 to -1.41)	-2.11 (-2.67 to -1.55)	-2.26 (-2.82 to -1.70)

Population analysed: Modified Full Analysis Set (mFAS) included all randomized participants who have received at least 1 dose of study drug and are not from Site 115. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome measure.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 up to Week 14. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin	1 of 54 (1.9%)	12 of 54 (22.2%)	0 of 54
Suzetrigine (SUZ): Low Dose	0 of 28 (0%)	4 of 28 (14.3%)	0 of 28
Suzetrigine (SUZ): Mid Dose	2 of 55 (3.6%)	5 of 55 (9.1%)	1 of 55
Suzetrigine (SUZ): High Dose	1 of 55 (1.8%)	7 of 55 (12.7%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

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Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
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Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

50 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Suzetrigine and Pregabalin in people with Diabetic Peripheral Neuropathy, run by Vertex Pharmaceuticals Incorporated at 50 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 3 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: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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 a Numeric Pain Rating Scale (NPRS) (time frame: Baseline, At Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05660538.

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 1 Jul 2025.