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NCT05791201Active, not recruitingPhase 1/2

A Safety, Tolerability, and Efficacy Study of VX-264 in Participants With Type 1 Diabetes

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-264 in Subjects With Type 1 Diabetes Mellitus

Source: ClinicalTrials.gov · Last updated 9 Oct 2026

Brief summary (registry, in English)

The purpose of the study is to evaluate the safety, tolerability, and efficacy of VX-264 in participants with type 1 diabetes (T1D).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
7 (actual)
First submitted
16 Mar 2023
Start date
16 May 2023
Primary completion date
12 Mar 2027
Lead sponsor
Vertex Pharmaceuticals Incorporated
NCT number
NCT05791201
EU CT number
2024-515583-32-00
EudraCT number
2022-003318-35

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 7
  • From 16 May 2023 to the primary completion date, 12 Mar 2027
  • 17 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior islet cell transplant, organ transplant, or cell therapy

Who the study is looking for

  • Clinical history of T1D with greater than or equal to (\>=) 5 years duration Participant is on a stable diabetic treatment Consistent use of continuous glucose monitoring (CGM) for at least 4 weeks before Screening and willingness to use CGM for the duration of the study

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Alberta Edmonton
Coordinator of this site? Confirm its status
EdmontonCanadaUnknown status
Montreal Clinical Research Institute
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
Toronto General Hospital (TGH)
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Vancouver General Hospital
Coordinator of this site? Confirm its status
VancouverCanadaUnknown status
Hopiteaux Universitaires de Geneve
Coordinator of this site? Confirm its status
GenevaSwitzerlandUnknown status
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Coordinator of this site? Confirm its status
DresdenGermanyActive, not recruiting
Royal Victoria Infirmary
Coordinator of this site? Confirm its status
Newcastle upon TyneUnited KingdomUnknown status
Churchill Hospital
Coordinator of this site? Confirm its status
OxfordUnited KingdomUnknown status
Ospedale San Raffaele S.r.l.
Coordinator of this site? Confirm its status
MilanItalyActive, not recruiting
Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l. I.S.M.E.T.T. S.r.l.
Coordinator of this site? Confirm its status
PalermoItalyActive, not recruiting
Leids Universitair Medisch Centrum (LUMC)
Coordinator of this site? Confirm its status
LeidenNetherlandsActive, not recruiting
Massachusetts General Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
University of Chicago
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
University of Wisconsin
Coordinator of this site? Confirm its status
MadisonUnited StatesUnknown status
UHealth Diabetes Research Institute
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
Hospital of the University of Pennsylvania
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
University of Pittsburgh Medical Center Montefiore
Coordinator of this site? Confirm its status
PittsburghUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.

A Safety, Tolerability, and Efficacy Study of VX-264 in Participants With Type 1 Diabetes (NCT05791201) – Frontlight Research