A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes

NCT04786262 · tracked via the Priya Life Science USA tracker

Sponsor

Vertex Pharmaceuticals Incorporated

Phase

Phase 3

Started

2021-03-29

Last updated

2026-09-01

Condition(s) studied

Diabetes Mellitus, Type 1Impaired Hypoglycemic AwarenessSevere Hypoglycemia

Investigational drug(s) / intervention(s)

VX-880VX-017

VX-880: Infused into the hepatic portal vein.

VX-017: Infused into the hepatic portal vein.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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

Primary outcome measure(s)

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)

Trial sites (29)

Facility	City	Region	Status
City of Hope	Duarte	California	Recruiting
University of California San Francisco	San Francisco	California	Recruiting
UHealth Diabetes Research Institute	Miami	Florida	Recruiting
Northwestern Organ Transplant Center	Chicago	Illinois	Completed
University of Chicago	Chicago	Illinois	Recruiting
Johns Hopkins University	Baltimore	Maryland	Completed
Massachusetts General Hospital	Boston	Massachusetts	Recruiting
Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	Recruiting
University of Pittsburgh Medical Center Montefiore	Pittsburgh	Pennsylvania	Recruiting
Baylor Scott and White Research Institute	Dallas	Texas	Recruiting
VCU Medical Center, Richmond	Richmond	Virginia	Recruiting
University of Wisconsin	Madison	Wisconsin	Recruiting
University of Alberta, Edmonton	Edmonton	Canada	Recruiting
McGill University Health Centre	Montreal	Canada	Recruiting
Toronto General Hospital (TGH)	Toronto	Canada	Recruiting
Vancouver General Hospital	Vancouver	Canada	Recruiting
CHU Lille	Lille	France	Recruiting
Centre de recherche en Biomédecine de Strasbourg	Strasbourg	France	Recruiting
Dresden Center for Islet Transplantation	Dresden	Germany	Recruiting
IRCCS Ospedale San Raffaele	Milan	Italy	Recruiting
Leiden University	Leiden	Netherlands	Recruiting
Oslo University Hospital	Oslo	Norway	Recruiting
King Abdullah International Medical Research Center (KAIMRC) - Riyadh - Endocrinology	Riyadh	Saudi Arabia	Recruiting
King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology	Riyadh	Saudi Arabia	Recruiting
Hopiteaux Universitaires de Geneve	Geneva	Switzerland	Completed
Churchill Hospital	Headington	Oxford	Recruiting
Royal Infirmary of Edinburgh	Edinburgh	United Kingdom	Recruiting
Cardiovascular, Metabolic Medicine and Sciences, King's College London	London	United Kingdom	Recruiting
The Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle upon Tyne	United Kingdom	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04786262 on ClinicalTrials.gov ↗ ← All trials in the USA