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A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-880 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia

NCT04786262•Vertex Pharmaceuticals Incorporated

View on ClinicalTrials.gov

Summary

This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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 before Screening and willingness to use CGM for the duration of the study

Exclusion Criteria

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

Locations (29)

City of Hope

Duarte, California, United States

University of California San Francisco

San Francisco, California, United States

UHealth Diabetes Research Institute

Miami, Florida, United States

Northwestern Organ Transplant Center

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Johns Hopkins University

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center Montefiore

Pittsburgh, Pennsylvania, United States

Baylor Scott and White Research Institute

Dallas, Texas, United States

Key Dates

Start Date

March 29, 2021

Primary Completion Date

June 30, 2027

Completion Date

June 30, 2030

Last Updated

March 17, 2026

Enrollment

ESTIMATED participants

Conditions

Diabetes Mellitus, Type 1Impaired Hypoglycemic AwarenessSevere Hypoglycemia

Interventions

VX-880

BIOLOGICAL

Contacts

Medical Information

CONTACT

617-341-6777 medicalinfo@vrtx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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