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

Phase 2Active Not RecruitingNCT05791201

Vertex Pharmaceuticals Incorporated7 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Interventions

VX-264DRUG

Allogeneic human stem cell-derived islets.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (16)

UHealth Diabetes Research Institute

Miami, Florida, United States

University of Chicago

Chicago, Illinois, United States

Massachusetts General Hospital

Outcomes

Primary Outcomes

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

Time frame: From Day 1 up to 24 months

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

Time frame: From Baseline and at Day 90

Secondary Outcomes

Part C: Change in peak C-peptide during MMTT

Time frame: From Baseline up to 24 months

Part C: Change in Average Total Daily Insulin Dose

Time frame: From Baseline up to 24 months

Part C: Proportion of Participants who are Insulin Independent at One Point in Time

Time frame: From Day 180 up to Day 365

Part C: Change in HbA1c values

Time frame: From Baseline up to 24 months

Data from ClinicalTrials.gov

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