NCT04786262

A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes

Recruiting
PHASE3Ages 18–65InterventionalTreatment
Vertex Pharmaceuticals Incorporated
~57 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:VX-880VX-017

At a glance

Recruiting sites
26 of 29 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)
Measured over From VX-880 infusion to end of study (at least 5 years)
+2 more outcomes measured
Diabetes Mellitus, Type 1
Impaired Hypoglycemic Awareness
Severe Hypoglycemia
29 sites across 19 states
Canada4
United Kingdom3
California2
Illinois2
Pennsylvania2
France2
Saudi Arabia2
Florida1

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Eligibility criteria

Inclusion

Clinical history of T1D with \>=5 years of duration of insulin dependence
At least two episodes of documented severe hypoglycemia in the 12 months prior to enrollment
Stable diabetic treatment
Consistent use of continuous glucose monitor (CGM) for at least 3 months before Screening and willingness to use CGM for the duration of the study

Exclusion

Prior islet cell transplant, organ transplant, or cell therapy
  • Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)From VX-880 infusion to end of study (at least 5 years)
  • Parts B and C: Proportion of Participants who are Insulin Independent with Absence of Severe Hypoglycemic Events (SHEs)1 year after achieving insulin independence (following VX-880 infusion)
  • Part D: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)From VX-017 infusion to end of study (at least 5 years)