Recruiting
Phase 3

VX-880

Sponsor:

Vertex Pharmaceuticals Incorporated

Code:

NCT04786262

Conditions

Diabetes Mellitus, Type 1

Impaired Hypoglycemic Awareness

Severe Hypoglycemia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

VX-880

VX-017

Study Details

Brief summary:

This study will evaluate the safety, tolerability and efficacy of VX-880 infusion and VX-017 infusion in participants with type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.

Conditions

Diabetes Mellitus, Type 1

Impaired Hypoglycemic Awareness

Severe Hypoglycemia

Study ID

NCT04786262

Start date

Mar 29, 2021

Status verified date

Aug, 2026

Completion date

Dec 31, 2031

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Key Exclusion Criteria:

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

Other protocol-defined Inclusion/Exclusion criteria may apply

Study Design

Enrollment

57 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VX-880

experimental: VX-017

Interventions

VX-880

Infused into the hepatic portal vein.

VX-017

Infused into the hepatic portal vein.

Primary outcome measure

  • Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: From VX-017 infusion to end of study (at least 5 years) ]

Central Contacts and Locations

Central contacts

Medical Information

617-341-6777medicalinfo@vrtx.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

UHealth Diabetes Research Institute

Recruiting

Miami, Florida, United States, 33136

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

University of Pittsburgh Medical Center Montefiore

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Baylor Scott and White Research Institute

Recruiting

Dallas, Texas, United States, 75246

VCU Medical Center, Richmond

Recruiting

Richmond, Virginia, United States, 23298

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

University of Alberta, Edmonton

Recruiting

Edmonton, Canada

McGill University Health Centre

Recruiting

Montreal, Canada

Toronto General Hospital (TGH)

Recruiting

Toronto, Canada

Vancouver General Hospital

Recruiting

Vancouver, Canada

More Information

Sponsor

Vertex Pharmaceuticals Incorporated

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Vertex Pharmaceuticals Incorporated on 2026-09-01.