NCT04786262 · Vertex Pharmaceuticals Incorporated
A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes
What this study is about
This study will evaluate the safety, tolerability and effectiveness of VX-880 infusion in participants with Type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.
View original scientific description
This study will evaluate the safety, tolerability and efficacy of VX-880 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.
Primary outcome measures
Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)
Time frame: From VX-880 infusion to end of study (up to 5 years)
Parts B and C: Proportion of Participants who are Insulin Independent with Absence of Severe Hypoglycemic Events (SHEs)
Time frame: 1 year after achieving insulin independence
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Duarte, California
- San Francisco, California
- Miami, Florida
- Chicago, Illinois
- Baltimore, Maryland
- Boston, Massachusetts
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Dallas, Texas
- Richmond, Virginia
- Madison, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 30, 2026 · Source of record for eligibility and locations