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Vx-264

Clinical trials are studying Vx-264 in people with type 1 diabetes. These studies aim to check safety, tolerability, and early signs of benefit, including how the body responds over time. The target group is subjects with type 1 diabetes mellitus.

Table of Contents

Trial overview

This clinical trial is an interventional study, which means researchers are giving a study treatment and then watching what happens.[1] The study is titled “A Safety, Tolerability, and Efficacy Study of VX-264 in Subjects With Type 1 Diabetes.”[1] It is currently listed as Authorised and plans to enroll 17 subjects.[1]

Who is being studied

The target population is people with type 1 diabetes mellitus.[1] In the trial record, the condition is listed as Type 1 Diabetes Mellitus, and the brief summary says the study is evaluating Vx-264 in subjects with T1D.[1] The source data do not provide more detailed participation rules such as age limits or other entry requirements.[1]

Study design and phase

The study is in Phase 1/2, which is an early research stage.[1] Phase 1/2 studies usually focus first on safety, then begin to look for early signs that the treatment may help.[1] The intervention listed is a VX-264 Implant given by implantation.[1]

The trial has multiple parts, including Part A, Part B, and Part C.[1] The source data show that Part A and Part B focus on safety and tolerability, while Part C looks at a measure of function called peak C-peptide during a mixed meal tolerance test at Day 90.[1]

What the trial measures

The main outcomes in Parts A and B are safety and tolerability.[1] Safety is checked by looking at treatment-emergent adverse events, serious adverse events, adverse device effects, serious adverse device events, and device deficiencies.[1] The study also includes clinical laboratory tests, vital signs, standard 12-lead ECGs, imaging with ultrasound and magnetic resonance imaging, and retinopathy evaluation.[1]

The trial also records how many subjects receive less than the target number of VX-264 units because of adverse events or adverse device effects.[1] It also tracks how many subjects have VX-264 units explanted, which means removed, because of adverse events, adverse device effects, or unit integrity issues.[1] In Part C, the main measure is the change from baseline in peak C-peptide during the mixed meal tolerance test at Day 90.[1]

What the results may show

Based on the trial design, this study is mainly trying to learn whether Vx-264 can be used safely in people with type 1 diabetes.[1] It is also looking for early signs of function, measured by C-peptide, which can help show whether the body is making insulin.[1] Because this is an early-phase study with 17 subjects, it is not designed to give a final answer about long-term benefit.[1]

Trial IDPhaseCondition studiedStatusEnrollment
2024-515583-32-00Phase 1/2Type 1 Diabetes MellitusAuthorised17

FAQ

  • What is being studied in Vx-264 clinical trials? The trial is studying Vx-264 in people with type 1 diabetes. It looks at safety, tolerability, and early efficacy, which means whether it may show a useful effect.
  • Who can take part in the Vx-264 trial? The trial is for subjects with type 1 diabetes mellitus. The data provided do not give more detailed entry rules.
  • What phase is the Vx-264 study? This is a Phase 1/2 study. Phase 1/2 trials usually look at early safety and also begin to check whether the treatment may work.
  • What outcomes are being measured? The study measures safety and tolerability, including adverse events, lab tests, vital signs, ECGs, imaging, and eye checks. It also measures peak C-peptide during a mixed meal test at Day 90.
  • How many people are planned for the trial? The trial plans to enroll 17 subjects. This is a small early-stage study.

Ongoing Clinical Trials on Vx-264

  • Study on the Safety and Effects of VX-264 for Patients with Type 1 Diabetes

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany Italy The Netherlands

Glossary

  • Type 1 diabetes mellitus: A long-term condition where the body does not make enough insulin. People with this condition need careful monitoring and treatment.
  • Subject: A person who takes part in a clinical trial.
  • Interventional study: A study where researchers give a treatment or device and then watch what happens.
  • Phase 1/2: An early stage of research. It usually checks safety first and then begins to look for signs that the treatment may help.
  • Safety: How well a treatment can be used without causing harmful problems.
  • Tolerability: How well people can handle a treatment without major trouble.
  • Adverse event: Any unwanted medical problem that happens during a study, whether or not it is caused by the study treatment.
  • Serious adverse event: A serious medical problem during a study, such as one that is life-threatening or needs hospital care.
  • Device deficiency: A problem with the study device, such as a defect or failure to work as expected.
  • ECG: A test that records the heart's electrical activity.
  • MRI: Magnetic resonance imaging, a scan that makes detailed pictures of the inside of the body.
  • C-peptide: A substance in the blood that helps show how much insulin the body is making.
  • MMTT: Mixed meal tolerance test, a test used to see how the body responds to food and to measure insulin-related markers.

References

  1. https://clinicaltrials.gov/study/2024-515583-32-00