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NCT05791201 · ClinicalTrials.gov record · last posted 2026-06-04

A Safety, Tolerability, and Efficacy Study of VX-264 in Participants With Type 1 Diabetes

StatusActive, Not Recruiting
PhasePhase 1/2
Started2023-05-16
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
The purpose of the study is to evaluate the safety, tolerability, and efficacy of VX-264 in participants with type 1 diabetes (T1D).

Protocol amendment history 3 changes detected by DataLookout

2026-06-05
Primary endpoint(s) modified
WasPart A and Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), Part B and Part C: Change in Peak C-peptide during Mixed-Meal Tolerance Test (MMTT)
NowPart A and Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), Part B: Change in Peak C-peptide during Mixed-Meal Tolerance Test (MMTT)
2026-06-05
Primary completion pushed: 2026-05-29 → 2027-03-12
2026-06-05
Completion pushed: 2026-05-29 → 2027-03-12
Trial Details
NCT Number NCT05791201
Lead Sponsor Vertex Pharmaceuticals Incorporated
Conditions Type 1 Diabetes
Enrollment 7 participants
Start Date 2023-05-16
Primary Completion 2027-03-12 (estimated)
Study Completion 2027-03-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-04