Recent Updates
Recently added Catalysts

VX-880

Phase 3

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment57

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 and VX-017 in Participants With Type 1 DiabetesDiabetes Mellitus, Type 1
RECRUITING57 Analytics
PHASE3RECRUITING
A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes
Diabetes Mellitus, Type 1Unlock trial analytics

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 (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)

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 Glycated Hemoglobin (HbA1c) less than (<) 7.0%
SHEs: from Day 90 through 1 year (inclusive) after VX-880 infusion; HbA1c < 7% at 1 year after VX-880 infusion
Parts B and C: Change From Baseline in Glycated Hemoglobin (HbA1c)
At 1 year after VX-880 infusion
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VX-880EXPERIMENTAL -
VX-017EXPERIMENTAL -

Interventions

NameTypeDescription
VX-880BIOLOGICALInfused into the hepatic portal vein.
VX-017BIOLOGICALInfused into the hepatic portal vein.
Unlock Study Design Details

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
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

MEDIUMSep 1, 2026NCT04786262Enrollment: 52 → 57
MEDIUMSep 1, 2026NCT04786262Enrollment: 52 → 57
LOWJun 30, 2026NCT04786262lastUpdatePostDate: changed
LOWJun 30, 2026NCT04786262lastUpdatePostDate: changed
LOWJun 30, 2026NCT04786262lastUpdatePostDate: changed

Frequently asked questions about VX-880

What is VX-880 used for in Type 1 Diabetes?

VX-880 is an investigational therapy being developed for the treatment of Type 1 Diabetes Mellitus, including cases with impaired hypoglycemic awareness and severe hypoglycemia. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.

Who makes VX-880?

VX-880 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX. The company is conducting clinical trials to evaluate the safety, tolerability, and efficacy of VX-880 in participants with Type 1 Diabetes.

What phase is VX-880 in?

VX-880 is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials to assess its safety and effectiveness for treating Type 1 Diabetes.

What clinical trials is VX-880 in?

VX-880 is being studied in a Phase 3 clinical trial with the identifier NCT04786262. This recruiting study evaluates VX-880 and VX-017 in participants with Type 1 Diabetes, impaired hypoglycemic awareness, and severe hypoglycemia, with an enrollment target of 57 participants across multiple countries.

What does VX-880 target?

The specific molecular target of VX-880 has not been disclosed. VX-880 is a monoclonal antibody being investigated for its potential role in treating Type 1 Diabetes, but its mechanism of action has not been publicly detailed in the available clinical trial information.