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VX-880

Phase 3

Diabetes Mellitus, Type 1 | Monoclonal antibody | Metabolic |Vertex Pharmaceuticals Incorporated|Last Updated: Jun 30, 2026

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical trial landscape

VX-880 · 1 trial · 3 indications

Phase 3 1
NCT04786262A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 DiabetesDiabetes Mellitus, Type 1
RECRUITING52 Analytics
PHASE3RECRUITING
A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes
Diabetes Mellitus, Type 1
NCT0478626252
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Study Endpoints
Primary Endpoints
Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)
From VX-880 infusion to end of study (up to 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
Secondary Endpoints
Parts B and C: Proportion of Participants who are Insulin Independent
At 1 year after VX-880 infusion
Parts B and C: Proportion of Participants Free from SHEs with a Glycosylated Hemoglobin (HbA1c) less than (<) 7.0%
At 1 year after VX-880 infusion
Parts B and C: Change From Baseline in Glycosylated Hemoglobin (HbA1c)
At 1 year after VX-880 infusion
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
VX-880EXPERIMENTAL -
Interventions
NameTypeDescription
VX-880BIOLOGICALInfused into the hepatic portal vein.
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Eligibility Criteria
Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites29

Key Inclusion Criteria: * 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 b...

Countries:United StatesCanadaFranceGermanyItalyNetherlandsNorwaySaudi ArabiaSwitzerlandUnited Kingdom
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Recent Changes (Last 90 Days)
LOWJun 30, 2026NCT04786262lastUpdatePostDate: changed
LOWJun 30, 2026NCT04786262lastUpdatePostDate: changed
LOWJun 30, 2026NCT04786262lastUpdatePostDate: changed
LOWMay 26, 2026NCT04786262primaryCompletionDate: changed
LOWMay 24, 2026NCT04786262studyFirstPostDate: changed