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Clinical Trials in the UK / NCT04786262
Recruiting Phase 3

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 UK 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-880 →VX-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
No
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)

FacilityCityRegionStatus
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

More Vertex Pharmaceuticals Incorporated trials in the UK

Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy Recruiting
A Phase 1/2 Study of VX-670 in Adult Participants With Myotonic Dystrophy 1 (DM1) Active, not recruiting
Evaluation of Safety and Efficacy of CTX001 in Pediatric Participants With Transfusion-Dependent β-Thalassemia (TDT) Active, not recruiting
A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy Active, not recruiting
A Long-term Follow-up Study in Participants Who Received CTX001 Enrolling by invitation

Other trials for the same condition

Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension) Active, not recruiting
A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults Recruiting
Supplementation With B. Infantis for Mitigation of Type 1 Diabetes Autoimmunity Active, not recruiting
A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE) Recruiting
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 UK