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ADENO-ASSOCIATED VIRUS SEROTYPE 9 CONTAINING THE HUMAN GCG GENE

Clinical trials of ADENO-ASSOCIATED VIRUS SEROTYPE 9 CONTAINING THE HUMAN GCG GENE are studying a first-in-human treatment approach in adults with inadequately controlled type 2 diabetes. The trial is designed to check safety and tolerability, and it also looks at laboratory changes and adverse events. It is a Phase 1/2 study with 50 planned participants.

Table of Contents

Trial overview

The available trial is a first-in-human study of ADENO-ASSOCIATED VIRUS SEROTYPE 9 CONTAINING THE HUMAN GCG GENE in adults with inadequately controlled type 2 diabetes.[1] It is designed to evaluate safety and tolerability, which means the researchers want to see how the study treatment is handled by the body and whether it causes important problems.[1]

Who is being studied

The target population is adults with type 2 diabetes whose condition is not well controlled.[1] The source data does not give more details about age limits, lab cutoffs, or other eligibility rules, so only this group can be confirmed from the trial record.[1]

Study phase and design

This study is listed as a Phase 1/2 trial.[1] Early-phase trials like this usually focus first on safety, and they may also begin to look for early signs that the treatment has a useful effect.[1]

The trial is interventional, which means participants receive the study treatment rather than only being observed.[1] The intervention is listed as RJVA-001 given by endoscopic ultrasound-guided delivery, a procedure that uses an endoscope and ultrasound imaging to guide treatment placement inside the body.[1]

What researchers measure

The main outcome is the incidence and severity of adverse events, plus any dose-relationship and changes in laboratory evaluations.[1] Adverse events are unwanted medical problems that happen during a study, and laboratory evaluations are tests such as blood work that help researchers watch for changes in health.[1]

These outcomes are important because they help show whether the treatment appears safe enough for further study and whether different treatment amounts may affect the body differently.[1]

Trial status and size

The trial status is Authorised, which means it has been approved to begin according to the source record.[1] The planned enrollment is 50 participants, making this a small early study.[1]

Trial ID Phase Condition studied Status Enrollment
2025-524438-24-00 Phase 1/2 Type 2 Diabetes Authorised 50

FAQ

  • What is being studied in these clinical trials? The trial is studying ADENO-ASSOCIATED VIRUS SEROTYPE 9 CONTAINING THE HUMAN GCG GENE in adults with inadequately controlled type 2 diabetes. The main goal is to evaluate safety and tolerability.
  • Who can take part in the trial? The trial is for adults with inadequately controlled type 2 diabetes. The source data does not list more detailed eligibility rules.
  • What phase is this trial? This is a Phase 1/2 trial. Phase 1/2 studies usually look at early safety and also begin to explore whether the treatment may have a useful effect.
  • What results are the researchers measuring? The main results are the number and severity of adverse events, any dose-related effects, and changes in laboratory tests. These measures help show how the treatment is tolerated.
  • How many people are planned for the study? The trial plans to enroll 50 people. This is a relatively small early-stage study.

Ongoing Clinical Trials on ADENO-ASSOCIATED VIRUS SEROTYPE 9 CONTAINING THE HUMAN GCG GENE

  • A study to assess the safety of RJVA-001 in adults with type 2 diabetes that is not well controlled by current medications.

    Not yet recruiting

    1 1
    Investigated drugs:
    The Netherlands

Glossary

  • Type 2 diabetes: A long-term condition where the body has trouble controlling blood sugar levels.
  • Inadequately controlled: Not well managed, meaning the condition is still not under good control.
  • First-in-human: The first time a treatment is tested in people.
  • Phase 1/2: An early clinical trial stage that checks safety first and may also look for early signs of benefit.
  • Interventional study: A study where researchers give a treatment and then observe what happens.
  • Safety: How well a treatment can be used without causing harmful problems.
  • Tolerability: How well people can handle a treatment and its effects.
  • Adverse events: Medical problems or unwanted effects that happen during a study.
  • Laboratory evaluations: Blood tests or other lab tests used to check health changes during a trial.
  • Dose-relationship: Whether side effects or changes become stronger or more common at different treatment amounts.

References

  1. https://clinicaltrials.gov/study/2025-524438-24-00