Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Translational Phase 1B, 2-Part Study to Evaluate Pharmacokinetics, Safety and Pharmacodynamics of Treatment with ATX-304 Na Salt Tablets.

This research study is looking into a new tablet called ATX-304. It's designed for individuals who are overweight or obese and also have either prediabetes (meaning their blood sugar is higher than normal but not yet full diabetes) or type 2 diabetes. The main goals are to see how the body handles this new medicine, how safe it is, and what effects it has. This is an early-stage study, meaning it's one of the first times it's being tested in people. Scientists will be checking how the medicine moves through the body, how long it stays, and if it causes any side effects, aiming to understand if it could be a helpful treatment in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Betagenon AB

Enrolment target

Start

15 Sep 2023

Obesity with prediabetes or type 2 diabetes mellitus

What is this study about?

This study is investigating a new medication called ATX-304, in the form of tablets. It's specifically for people who are overweight or obese and also have prediabetes or type 2 diabetes. Prediabetes means your blood sugar levels are higher than normal, putting you at risk of developing type 2 diabetes. Type 2 diabetes is a long-term condition that causes a person's blood sugar level to become too high.

The main purpose of this research is to learn more about how this new medicine works in the human body. Researchers want to understand how the body uses, breaks down, and gets rid of the medication. This is important for figuring out the right dose and how often it should be taken. They also want to carefully check for any side effects and make sure the medication is safe for people to use.

This is an early-stage study, often called a 'Phase 1' study. These studies are crucial because they help scientists understand the basic properties of a new drug before it can be tested in larger groups of people. By taking part, volunteers help gather vital information that could lead to new treatment options for obesity and diabetes in the future.

Key takeaways

This study tests a new tablet (ATX-304) for obesity with prediabetes or type 2 diabetes.
It's an early-stage study focusing on safety and how the body handles the medicine.
Participants must be 18 or older and have obesity with prediabetes or type 2 diabetes.
Participation involves clinic visits, taking study medication, and medical checks.
You can leave the study at any time without affecting your normal care.

Who may be eligible?

To be able to join this study, you need to be an adult, aged 18 or older. There is no upper age limit, meaning older adults can also take part.

This study is open to both men and women. The most important health conditions for joining are being overweight or obese, and also having either prediabetes or type 2 diabetes. The study team will check your medical history and conduct tests to make sure you meet these specific health requirements.

There will be other detailed criteria that the study team will go through with you. These could include things like other health conditions you might have, medicines you are currently taking, or specific test results. These checks are in place to ensure your safety and that the study results are as clear and accurate as possible.

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 a diagnosis of obesity or are you considered overweight?
Have you been told you have prediabetes or type 2 diabetes?
Are you able to attend appointments at a study clinic regularly?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will likely need to make several visits to a clinic or research centre. During these visits, the study team will carry out various assessments. These might include blood tests to check how the medication is affecting your body and to monitor for any side effects, as well as checking your blood sugar levels, blood pressure, and weight.

You will be given the study medication, ATX-304, in tablet form to take as instructed. The study will also involve follow-up checks after you stop taking the medication to ensure your health is stable. The total duration of your involvement in the study, from your first visit to your last follow-up, will be explained fully by the study team.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new investigational medication that might help manage your obesity, prediabetes, or type 2 diabetes, and you'll receive careful medical monitoring. However, there are also potential risks, including side effects from the study medication, which the team will explain in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands
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Unverified
Germany

Common questions

What is prediabetes?

Prediabetes means your blood sugar levels are higher than normal, but not high enough to be diagnosed as type 2 diabetes. It means you're at a higher risk of developing type 2 diabetes.

What does 'Phase 1' study mean?

A Phase 1 study is an early stage of clinical research. Its main goal is to check the safety of a new medicine and see how it works in the body, rather than how effective it is for a specific condition.

Will I know if I'm getting the active drug or a dummy pill?

In some studies, participants are given either the active drug or a 'dummy pill' (placebo). The study team will explain if this is the case for this particular trial and how it works.

Do I have to pay to join the study?

No, you do not have to pay to participate in clinical trials. In fact, some studies may offer reimbursement for your time and travel expenses.

What if I have other health problems?

The study team will carefully review your full medical history to make sure taking part is safe for you and won't interfere with your existing health conditions or medications.