NCT04786262 A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes
| NCT ID | NCT04786262 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Vertex Pharmaceuticals Incorporated |
| Condition | Diabetes Mellitus, Type 1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2021-03-29 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 52 participants in total. It began in 2021-03-29 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04786262 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Diabetes Mellitus, Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04786262 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 52 participants.
Is NCT04786262 currently recruiting?
Yes, NCT04786262 is actively recruiting participants. Contact the research team at medicalinfo@vrtx.com for enrollment information.
Where is the NCT04786262 trial being conducted?
This trial is being conducted at Duarte, United States, San Francisco, United States, Miami, United States, Chicago, United States and 11 additional locations.
Who is sponsoring the NCT04786262 clinical trial?
NCT04786262 is sponsored by Vertex Pharmaceuticals Incorporated. The trial plans to enroll 52 participants.
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