A Phase 1/2 Open-Label, Single Ascending Dose, First-In-Human Study to Assess Safety and Tolerability of Endoscopic Ultrasound-Guided Pancreatic Infusion of RJVA-001 in Adults With Inadequately Controlled Type 2 Diabetes on Multiple Glucose-Lowering Agents.
This study is a first look at a new treatment called RJVA-001 for adults living with Type 2 diabetes, especially those whose blood sugar isn't well-managed even with other medications. It's being given for the first time to people to check its safety and how well people tolerate it. The treatment is given directly into the pancreas using a special scope. Researchers will carefully watch for any side effects and how the body reacts to different doses. They will also measure changes in blood sugar to see if the treatment helps. This early-stage study is crucial for understanding if RJVA-001 could be a future option for improving Type 2 diabetes control.
At a glance
What is this study about?
This study is looking at a brand new treatment, called RJVA-001, for people who have Type 2 diabetes. It's especially for adults whose diabetes is proving hard to manage, even though they're already taking several different medicines to control their blood sugar. The main goal of this study is to see if this new treatment is safe and how well people tolerate it, which means checking for any side effects and how severe they might be.
Because this is the very first time RJVA-001 is being given to people, researchers will start with a small dose and gradually increase it. They will carefully observe how each dose affects participants, looking at blood test results and any changes in their health. The treatment is given directly into the pancreas, a gland in your body that helps control blood sugar, using a special camera on a flexible tube called an endoscope.
Beyond safety, the study will also look at how RJVA-001 might affect blood sugar levels. This involves checking various measurements over time, including how well the body uses sugar and changes in sugar levels monitored continuously. Understanding these effects is key to knowing if RJVA-001 could be a helpful new option for managing Type 2 diabetes in the future.
Key takeaways
- This is a new treatment for hard-to-control Type 2 diabetes.
- It's the first time this treatment (RJVA-001) is being tested in humans.
- The main goal is to check safety and how well people tolerate it.
- The treatment is given directly into the pancreas.
- Researchers will also look at effects on blood sugar levels.
Who may be eligible?
To be considered for this study, you must be an adult, aged 18 years or older, with Type 2 diabetes. The study is open to both men and women.
Importantly, your Type 2 diabetes should not be well-controlled, even though you are already taking several different medications to help manage your blood sugar levels. This study is specifically for those who find their diabetes difficult to control with current treatments.
There might be other specific medical conditions or previous treatments that would mean you couldn't join the study, but these details would be discussed with you by the study team after a medical review.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have Type 2 diabetes?
- Is your Type 2 diabetes not well-controlled even with other medications?
- Have you discussed this study with your doctor?
What does participation involve?
If you join this study, you will receive the new treatment, RJVA-001, which is given directly into your pancreas using a procedure similar to an endoscopy. You will have regular visits to the clinic so the study team can closely monitor your health. These visits will include checks for any side effects, blood tests, and other health assessments. Doctors will carefully adjust the dose of RJVA-001 you receive, starting low and increasing it slowly, to find the safest and most effective amount. You will also use a continuous glucose monitor to track your blood sugar levels. The full length of your involvement in the study, including treatment and follow-up checks, will be explained in detail by the study team, but it will involve multiple visits over a period of time.
Potential risks and benefits
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Common questions
What is Type 2 diabetes?
Type 2 diabetes is a condition where your body doesn't use insulin properly or doesn't make enough insulin, leading to high blood sugar levels. Insulin is a hormone that helps sugar get into your cells for energy.
What does 'first-in-human' mean?
This means that RJVA-001 has never been given to people before. It's the very first time it's being tested in humans after being studied in laboratories and sometimes in animals.
How is RJVA-001 given?
RJVA-001 is given directly into your pancreas using a special flexible tube with a camera, a procedure called endoscopic ultrasound-guided infusion. This is done by a healthcare professional.
What are 'glucose-lowering agents'?
These are the different medicines (tablets or injections) that people with Type 2 diabetes take to help reduce their blood sugar levels.
What are adverse events?
Adverse events are any unwanted or unexpected health problems that happen during the study, whether they are related to the treatment or not. The study team will carefully track all of these.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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