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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified February 2026 by Vertex Pharmaceuticals Incorporated
Sponsor
Vertex Pharmaceuticals Incorporated
Information Provided by (Responsible Party)
Vertex Pharmaceuticals Incorporated
Clinicaltrials.gov Identifier
NCT04786262
Other Study ID Numbers:
VX20-880-101
First Submitted
March 2, 2021
First Posted
March 7, 2021
Last Update Posted
March 16, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on March 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Diabetes Mellitus, Type 1Impaired Hypoglycemic AwarenessSevere Hypoglycemia
Biological: VX-880

Study Design

Study TypeInterventional
Actual Enrollment52 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-880 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia
Study Start DateMarch 28, 2021
Actual Primary Completion Date1yr 1mo from now
Actual Study Completion Date4yrs 1mo from now

Groups and Cohorts

Group/CohortIntervention/Treatment
VX-880
Biological: VX-880
Infused into the hepatic portal vein.

Outcome Measures

Primary Outcome Measures
  1. Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)
  2. Parts B and C: Proportion of Participants who are Insulin Independent with Absence of Severe Hypoglycemic Events (SHEs)
Secondary Outcome Measures
  1. Parts B and C: Proportion of Participants who are Insulin Independent
  2. Parts B and C: Proportion of Participants Free from SHEs with a Glycosylated Hemoglobin (HbA1c) less than (<) 7.0%
  3. Parts B and C: Change From Baseline in Glycosylated Hemoglobin (HbA1c)
  4. Parts B and C: Proportion of Participants Who Maintain Insulin Independence for at least 1 year
  5. Parts B and C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsVertex Pharmaceuticals Incorporated
Locations
City of Hope | Duarte California, United States, 91010University of California San Francisco | San Francisco California, United States, 94143UHealth Diabetes Research Institute | Miami Florida, United States, 33136Northwestern Organ Transplant Center | Chicago Illinois, United States, 60611University of Chicago | Chicago Illinois, United States, 60637Johns Hopkins University | Baltimore Maryland, United States, 21287Massachusetts General Hospital | Boston Massachusetts, United States, 02114Hospital of the University of Pennsylvania | Philadelphia Pennsylvania, United States, 19104University of Pittsburgh Medical Center Montefiore | Pittsburgh Pennsylvania, United States, 15213Baylor Scott and White Research Institute | Dallas Texas, United States, 75246VCU Medical Center, Richmond | Richmond Virginia, United States, 23298University of Wisconsin | Madison Wisconsin, United States, 53792University of Alberta, Edmonton | Edmonton , Canada, McGill University Health Centre | Montreal , Canada, Toronto General Hospital (TGH) | Toronto , Canada, Vancouver General Hospital | Vancouver , Canada, CHU Lille | Lille , France, Centre de recherche en Biomédecine de Strasbourg | Strasbourg , France, Dresden Center for Islet Transplantation | Dresden , Germany, IRCCS Ospedale San Raffaele | Milan , Italy, Leiden University | Leiden , Netherlands, Oslo University Hospital | Oslo , Norway, King Abdullah International Medical Research Center (KAIMRC) - Riyadh - Endocrinology | Riyadh , Saudi Arabia, King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology | Riyadh , Saudi Arabia, Hopiteaux Universitaires de Geneve | Geneva , Switzerland, Churchill Hospital | Headington Oxford, United Kingdom, Royal Infirmary of Edinburgh | Edinburgh , United Kingdom, Cardiovascular, Metabolic Medicine and Sciences, King's College London | London , United Kingdom, The Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle upon Tyne , United Kingdom,