Active — Not RecruitingPhase 1/2

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

United States7 participantsStarted 2023-05-16

Plain-language summary

The purpose of the study is to evaluate the safety, tolerability, and efficacy of VX-264 in participants with type 1 diabetes (T1D).

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: Clinical history of T1D with greater than or equal to (\>=) 5 years duration Participant is on a stable diabetic treatment Consistent use of continuous glucose monitoring (CGM) for at least 4 weeks 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

What they're measuring

Part A and Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: From Day 1 up to 24 months

Part B and Part C: Change in Peak C-peptide during Mixed-Meal Tolerance Test (MMTT)

Timeframe: From Baseline and at Day 90

Trial details

NCT IDNCT05791201

SponsorVertex Pharmaceuticals Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-29

View on ClinicalTrials.gov More Type 1 Diabetes trials