RecruitingPHASE1INTERVENTIONAL

A Phase 1b Study of QX1206 in T2DM Patients With NAFLD

This study is testing a new drug called QX1206, which might help people who have both type 2 diabetes and non-alcoholic fatty liver disease (NAFLD). Doctors will give the drug and watch participants closely to find the safest and most effective dose for future studies. They will also look at how the drug affects blood sugar and other health measurements. This is an early-stage study, meaning it's one of the first times this drug is being tested in a small group of people to understand its effects and safety. The goal is to see if QX1206 can improve health conditions for these patients.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

1Globe Health Institute

Enrolment target

Start

06 Jan 2025

Estimated completion

01 Dec 2025

Type 2 Diabetes Mellitus (T2DM)Non-Alcoholic Fatty Liver Disease (NAFLD)

What is this study about?

This study is being carried out to learn more about a new medication called QX1206. It's designed for people who have two specific health conditions: type 2 diabetes and non-alcoholic fatty liver disease (NAFLD). We know that these conditions can affect each other, and researchers are hoping that QX1206 might help improve both.

The main goal of this particular study is to find the best dose of QX1206 to use in future, larger studies. This means doctors will be carefully giving different amounts of the drug to participants and closely monitoring their health. They will do various tests to see how the drug is working in the body and if it's causing any side effects. This careful process helps ensure that if the drug is eventually approved, it will be used safely and effectively.

Another important aim is to get an early look at whether QX1206 actually helps improve blood sugar levels and other related health markers in people with these conditions. It's a stepping stone to understanding the potential benefits of this new treatment. Remember, this is an early phase of research, so it's about gathering initial information, not about offering a new treatment that's already widely available.

Key takeaways

This study is testing a new drug for type 2 diabetes and fatty liver disease (NAFLD).
It's an early-stage study to find the best dose and check for safety and early effects.
Participation involves regular clinic visits, blood tests, and health checks.
You must meet specific health requirements to be eligible.
You can withdraw from the study at any time.
This is research; it is not immediate medical treatment.

Who may be eligible?

To be considered for this study, you need to be an adult between 18 and 64 years old. You must have been diagnosed with both type 2 diabetes and non-alcoholic fatty liver disease. There are also specific requirements about your body weight and certain blood test results to make sure the study can be safely carried out.

Some things would mean you couldn't join the study. For example, if your diabetes isn't well-controlled, or if you have other serious active medical conditions. You also can't have a history of significant alcohol consumption, as this can affect liver health. The study also has specific limits on certain blood test results, like high cholesterol or very high liver enzyme levels.

It's also important that you're not taking certain medications or supplements that might interfere with the study drug, such as high doses of vitamin E or other treatments for fatty liver that aren't part of the study. Women who could become pregnant must agree to use effective contraception, and will need to have a negative pregnancy test before starting.

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 between 18 and 64 years old?
Have you been diagnosed with both type 2 diabetes and non-alcoholic fatty liver disease?
Is your diabetes generally well-controlled (not currently out of control)?
Do you avoid significant alcohol consumption?
Are you able to attend regular clinic appointments and follow study instructions?
Are you not currently pregnant or planning to become pregnant during the study (if applicable)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have several visits to the study clinic. Before you start taking the study drug, doctors will do a full health check, including blood tests and other measurements, to see if you are suitable. During the study, you will be given the experimental drug, QX1206, and continue to have regular check-ups, blood tests, and other assessments. These appointments are really important for the research team to monitor your health and see how the drug is affecting you.

The study treatment is given without you or your doctor knowing if you are getting the active drug or a placebo (a dummy drug). This helps ensure fairness in the results. Throughout your time in the study, which will involve several weeks or months, the medical team will be on hand to answer any questions and address any concerns you might have. Once you finish taking the study drug, there will be a follow-up period to make sure your health remains stable.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as receiving careful medical monitoring and access to a new drug that isn't yet widely available, which may help with your conditions. However, there are also potential risks; QX1206 is still in an early stage of testing, so there might be side effects that are not yet fully known. You would be fully informed about known risks before deciding to join. Remember, taking part in a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Centricity Research Toronto LMC.
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is QX1206?

QX1206 is a new experimental drug being investigated to see if it can help people with type 2 diabetes and non-alcoholic fatty liver disease (NAFLD).

What does 'Phase 1b' mean?

Phase 1b means this is an early study where a new drug is given to a small group of people. The main goals are to find a safe and effective dose and to look for early signs of how the drug works.

Will I get the actual drug or a dummy pill?

In this specific 'open label' study, participants will know they are receiving the study drug QX1206, and won't receive a dummy pill.

How long will I be in the study?

The study involves a series of visits and tests over a period of time, which will be explained in detail by the research team.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any point, and this won't affect your regular medical care.

How to find out more

1Globe Health Institute

t2dm-qx1206-1_study@1globe-usa.com 617-649-1157 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.