In short
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.
Key points
- Clinical trials of ADENO-ASSOCIATED VIRUS SEROTYPE 9 CONTAINING THE HUMAN GCG GENE are being studied in adults with inadequately controlled type 2 diabetes. The main trial is a first-in-human, Phase 1/2 study. Researchers are focusing on safety, tolerability, adverse events, dose-related effects, and laboratory test changes. The study is interventional, meaning participants receive the study treatment and are then monitored. A total of 50 people are planned for enrollment. The trial status is authorised.
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. 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.
Who is being studied
The target population is adults with type 2 diabetes whose condition is not well controlled. 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.
Study phase and design
This study is listed as a Phase 1/2 trial. 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.
The trial is interventional, which means participants receive the study treatment rather than only being observed. 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.
What researchers measure
The main outcome is the incidence and severity of adverse events, plus any dose-relationship and changes in laboratory evaluations. 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.
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.
Trial status and size
The trial status is Authorised, which means it has been approved to begin according to the source record. The planned enrollment is 50 participants, making this a small early study.