NCT04786262RecruitingPhase 3
A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes
A Master Protocol to Evaluate the Safety, Tolerability, and Efficacy of Islet Cell Replacement Therapies in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia: A Phase 1/2/3 Study of VX-880 and a Phase 1/2 Study of VX-017
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 57 (estimated)
- First submitted
- 3 Mar 2021
- Start date
- 29 Mar 2021
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT04786262
- EU CT number
- 2024-513929-23-00
- EudraCT number
- 2022-002292-11
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 57
- From 29 Mar 2021 to the primary completion date, 31 Dec 2027
- 29 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- -Prior islet cell transplant, organ transplant, or cell therapy
Other
- Other protocol-defined Inclusion/Exclusion criteria may apply
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (29)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta Edmonton Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Toronto General Hospital (TGH) Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Vancouver General Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
| Hopiteaux Universitaires de Geneve Coordinator of this site? Confirm its status | Geneva | Switzerland | Completed |
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Recruiting |
| Royal Infirmary of Edinburgh Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Recruiting |
| Churchill Hospital Coordinator of this site? Confirm its status | Headington | United Kingdom | Recruiting |
| Cardiovascular, Metabolic Medicine and Sciences, King's College London Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| The Newcastle Upon Tyne Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Leiden University Medical Center Coordinator of this site? Confirm its status | Leiden | Netherlands | Recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| King Abdullah International Medical Research Center (KAIMRC) - Riyadh - Endocrinology Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Recruiting |
| King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Recruiting |
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Completed |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Northwestern Organ Transplant Center Coordinator of this site? Confirm its status | Chicago | United States | Completed |
| Baylor, Scott and White Research Institute Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| University of Wisconsin Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| UHealth Diabetes Research Institute Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Hospital of the University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| University of Pittsburgh Medical Center Montefiore Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| VCU Medical Center, Richmond Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.