Recruiting
A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes
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.
ClinicalTrials.gov IDNCT04786262
PhasePHASE3
Enrollment57
SponsorVertex Pharmaceuticals Incorporated
Age18 Years
SexALL
Conditions studied
Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness, Severe Hypoglycemia
About this study
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.
Interventions
- Biological: VX-880 — Infused into the hepatic portal vein.
- Biological: VX-017 — Infused into the hepatic portal vein.
Primary outcomes
- 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))
Eligibility information
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 locations
- City of Hope, Duarte, California 91010 United States
- University of California San Francisco, San Francisco, California 94143 United States
- UHealth Diabetes Research Institute, Miami, Florida 33136 United States
- Northwestern Organ Transplant Center, Chicago, Illinois 60611 United States
- University of Chicago, Chicago, Illinois 60637 United States
- Johns Hopkins University, Baltimore, Maryland 21287 United States
- Massachusetts General Hospital, Boston, Massachusetts 02114 United States
- Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania 19104 United States
- University of Pittsburgh Medical Center Montefiore, Pittsburgh, Pennsylvania 15213 United States
- Baylor Scott and White Research Institute, Dallas, Texas 75246 United States
Showing 10 of 29 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.