#1 Clinical Trials Search in Europe

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

Unfortunately, we did not find any clinical trials matching the selected criteria. Try changing the filter settings or broadening the search criteria to see more available research participation opportunities.

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