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

May 29, 2026 updated by: Vertex Pharmaceuticals Incorporated

A Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of Oral VX-993 in Subjects With Pain Associated With Diabetic Peripheral Neuropathy

The purpose of this study is to evaluate the efficacy, safety, and tolerability of VX-993 in participants with pain associated with Diabetic Peripheral Neuropathy (DPN)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
      • Brampton, Canada
        • Recruiting
        • Centricity Research Brampton
      • Kelowna, Canada
        • Recruiting
        • OCT Research ULC
      • Montreal, Canada
        • Recruiting
        • Altasciences - Beaumont Clinic Montreal
      • Toronto, Canada
        • Recruiting
        • Mount Sinai Hospital - Leadership Sinai Centre for Diabetes (LSCD)
  • France
      • Clermont-Ferrand, France
        • Recruiting
        • Centre Hospitalier Universitaire de Clermont-Ferrand - Site Gabriel-Montpied
      • Nîmes, France
        • Recruiting
        • CHU de Nîmes - Pain Assessment and Treatment Center
      • Paris, France
        • Recruiting
        • Hopital Cochin - Rheumatology
      • Saint-Priest-en-Jarez, France
        • Recruiting
        • North Hospital
  • Germany
      • Bad Oeynhausen, Germany
        • Recruiting
        • Ruhr-Universitaet Bochum - Heart and Diabetes Center
      • Berlin, Germany
        • Recruiting
        • FutureMeds GmbH
      • Offenbach/Main, Germany
        • Recruiting
        • FutureMeds Frankfurt
  • Italy
      • Milan, Italy
        • Recruiting
        • Fondazione IRCCS Istituto Neurologico Carlo Besta
      • Milan, Italy
        • Recruiting
        • IRCCS Ospedale San Raffaele - InSpe and Division of Neuroscience
  • United Kingdom
      • Birmingham, United Kingdom
        • Recruiting
        • FutureMeds Birmingham
      • Birmingham, United Kingdom
        • Recruiting
        • Birmingham Heartlands Hospital - Heartlands Hospital Diabetes Centre and MIDRU
      • Dundee, United Kingdom
        • Recruiting
        • Ninewells Hospital - Endocrinology
      • Glasgow, United Kingdom
        • Recruiting
        • FutureMeds Glasgow
      • Liverpool, United Kingdom
        • Recruiting
        • University of Liverpool - Aintree University Hospital
      • London, United Kingdom
        • Recruiting
        • St Pancras Clinical Research
      • Manchester, United Kingdom
        • Recruiting
        • Manchester Diabetes Centre (MDC)
      • Nuneaton, United Kingdom
        • Recruiting
        • George Eliot Hospital NHS Trust
      • Sheffield, United Kingdom
        • Recruiting
        • Royal Hallamshire Hospital - Endocrinology
  • United States
    • Alabama
      • Cullman, Alabama, United States, 35055
        • Completed
        • Cullman Clinical Trials
    • California
      • Bakersfield, California, United States, 93301
        • Completed
        • Trovare Clinical Research - Bakersfield CA
      • La Mesa, California, United States, 91942
        • Completed
        • Eximia Research - San Diego
    • Colorado
      • Wheat Ridge, Colorado, United States, 80033
        • Completed
        • Paradigm Clincial Research Centers, LLC., Wheat Ridge
    • Florida
      • DeLand, Florida, United States, 32720
        • Completed
        • Accel Research - Deland
      • Fort Myers, Florida, United States, 33912
        • Completed
        • AMR Fort Myers (The Clinical Study Center)
      • Hallandale, Florida, United States, 33009
        • Completed
        • Velocity Clinical Research - Hallandale Beach
      • Jupiter, Florida, United States, 33458
        • Completed
        • Health Awareness, Inc., Jupiter
      • Miami, Florida, United States, 33172
        • Completed
        • Suncoast Research Associates - Miami
      • Palmetto Bay, Florida, United States, 33157
        • Completed
        • Innovation Medical Research Center - Palmetto
      • Port Saint Lucie, Florida, United States, 34952
        • Completed
        • Health Awareness, Inc. - Port St. Lucie
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Completed
        • Atlanta Center for Medical Research
      • Decatur, Georgia, United States, 30030
        • Completed
        • Accel Research - Decatur
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Completed
        • Velocity Clinical Research - Boise
    • Illinois
      • Flossmoor, Illinois, United States, 604773027
        • Completed
        • Healthcare Research Network - Flossmoor IL
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Completed
        • Quest Research Institute
    • Missouri
      • Hazelwood, Missouri, United States, 63042
        • Completed
        • Healthcare Research Network - Hazelwood MO
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Completed
        • Eximia Research - Raleigh
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Completed
        • Velocity Clinical Research - Cleveland
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Completed
        • Velocity Clinical Research - Providence
    • South Carolina
      • Moncks Corner, South Carolina, United States, 29461
        • Completed
        • Clinical Trials of South Carolina - Berkeley - Moncks Corner
    • Texas
      • Beaumont, Texas, United States, 77702
        • Completed
        • Gadolin Research
      • Dallas, Texas, United States, 75230
        • Completed
        • Velocity Clinical Research, Dallas
      • San Antonio, Texas, United States, 78240
        • Completed
        • San Antonio Clinical Trials
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Completed
        • AMR Norfolk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Diagnosis of diabetes mellitus type 1 or type 2 with

    • Glycosylated hemoglobin A1c (HbA1c) less than or equal to (≤) 9% and
    • Presence of bilateral pain in lower extremities due to DPN (defined as a symmetric, length-dependent sensory or sensorimotor polyneuropathy) for at least 1 year

Key Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VX-993
Participants will be randomized to receive multiple doses of different dose levels of VX-993.
Drug: Placebo (matched to pregabalin)
Placebo matched to pregabalin for oral administration.
Drug: VX-993
Tablets for oral administration.
Active Comparator: Pregabalin
Participants will be randomized to receive Pregabalin.
Drug: Pregabalin
Capsules for oral administration.
Drug: Placebo (matched to VX-993)
Placebo matched to VX-993 for oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12
Time Frame: From Baseline up to Week 12
From Baseline up to Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of Participants with Greater than or Equal to (≥) 30 Percent (%) Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12
Time Frame: From Baseline up to Week 12
From Baseline up to Week 12
Proportion of Participants with ≥50% Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12
Time Frame: From Baseline up to Week 12
From Baseline up to Week 12
Proportion of Participants with ≥70% Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12
Time Frame: From Baseline up to Week 12
From Baseline up to Week 12
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Day 1 up to Week 16
Day 1 up to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2024

Primary Completion (Estimated)

March 25, 2027

Study Completion (Estimated)

April 22, 2027

Study Registration Dates

First Submitted

September 27, 2024

First Submitted That Met QC Criteria

September 27, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX24-993-103
  • 2024-514689-38-01 (Other Identifier: EU Trial (CTIS) Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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