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

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NCT04786262 · readout in 315 d

Sponsored by Vertex Pharmaceuticals Incorporated (industry) · VRTX — their whole pipeline →.

Phase

Phase 3

Status

Recruiting

Study type

Interventional

Design

Na · None · Treatment

Enrollment

52estimated

Sites

Countries

Canada, France, Germany +7

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2021-03-29

actual

When the study began enrolling

Primary completion

2027-06-30

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2030-06-30

estimated

The whole study's end, after follow-up

First posted

2021-03-08

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-06-30

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

Diabetes Mellitus, Type 1
Impaired Hypoglycemic Awareness
Severe Hypoglycemia

Intervention

Biological: VX-880 — also filed as Zimislecel, Formerly known as STx-02

Primary outcomes

what the primary-completion date above is the date OF

Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)

measured 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)

measured 1 year after achieving insulin independence

Publications

PMID 40544428 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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