Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Randomised, Double-blind, Placebo-controlled, Multi-centre Phase 2b Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) with Fibrosis Who Are Carriers of the PNPLA3 rs738409 148M Risk Allele.

This study is investigating a new medication called AZD2693. It's for adults (18 years and older) who have a liver condition known as non-alcoholic steatohepatitis (NASH), which involves fat and inflammation in the liver, along with some early scarring (fibrosis). Researchers are specifically focusing on people who carry a particular gene variant (PNPLA3 rs738409 148M risk allele), which can make them more likely to develop advanced liver disease. The main goal is to see if AZD2693 can reduce the signs of NASH without making the liver scarring worse over 52 weeks, and to assess its safety. Some people will receive the new medicine, while others will receive a dummy medicine (placebo), so we can compare the effects fairly.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

AstraZeneca AB

Enrolment target

Start

02 Jul 2024

Non-cirrhotic non-alcoholic steatohepatitis with fibrosis

What is this study about?

This research study is about a liver condition called non-alcoholic steatohepatitis, or NASH for short. NASH is a more serious form of fatty liver disease where there is not only fat but also inflammation and damage to the liver cells. Over time, this inflammation can lead to scarring, known as fibrosis. If NASH progresses and scarring becomes severe, it can lead to cirrhosis, which is a very serious and permanent form of liver damage.

The new medicine being tested is called AZD2693. The study is particularly interested in people with NASH who also have some early liver scarring (fibrosis). What makes this study special is that it’s looking at people who have a specific gene marker. This gene marker, called PNPLA3 rs738409 148M, has been linked to a higher risk of developing more advanced liver disease in people with NASH. Understanding how AZD2693 works in this group could be very important.

The main aim of this study is to see if AZD2693 can help clear up the signs of NASH in the liver without making the scarring worse. Specifically, doctors will be looking for improvements in the liver cells themselves, like reducing inflammation and fatty changes. They also want to make sure the medicine is safe and that people tolerate it well. By comparing the new medicine to a dummy medicine (placebo), researchers can get a clear picture of its potential benefits and any side effects.

Key takeaways

This study is testing a new medicine (AZD2693) for NASH with liver scarring.
It's for adults (18+) with a specific gene marker linked to advanced liver disease.
Participants will receive either the new medicine or a dummy medicine (placebo).
The main goal is to see if the medicine can improve NASH without worsening liver scarring over 52 weeks.
All participants will receive careful medical monitoring and support.

Who may be eligible?

This study is looking for adult volunteers, aged 18 years and older. Both men and women can take part.

To be considered for this study, you would need to have been diagnosed with a specific type of liver disease called non-alcoholic steatohepatitis, which also involves some early scarring (fibrosis) in your liver.

Crucially, you would also need to carry a specific gene marker (called PNPLA3 rs738409 148M), which can be identified through a simple test. This marker is important because it's linked to how NASH might progress. Your doctor will be able to confirm if you meet all the necessary health criteria for the study.

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?
Have you been diagnosed with non-alcoholic steatohepatitis (NASH)?
Do you have some early scarring (fibrosis) in your liver?
Do you carry the specific PNPLA3 rs738409 148M gene marker (your doctor can check this)?
Are you able to attend regular clinic appointments for about one year?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either the new medicine, AZD2693, or a dummy medicine (placebo), given as an injection. Neither you nor your study doctor will know which one you are receiving – this is to ensure fair results. The treatment period will last for 52 weeks, which is about one year.

Throughout the study, you would attend regular visits to the clinic. These visits will involve various assessments, such as blood tests, check-ups with the doctor, and possibly other tests to monitor your liver health and general well-being. A liver biopsy (a small sample of liver tissue) will likely be taken at the beginning and end of the study to check for changes in your liver scarring and NASH. You would be carefully monitored for any side effects.

After the 52 weeks of treatment, there will be a follow-up period to see how you are doing. The total duration of your involvement, including treatment and follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and risks. You might not directly benefit from receiving the study medicine, as some participants will receive a placebo. However, careful monitoring throughout the study means you will receive thorough medical attention for your liver condition. There's always a chance of side effects with any new medication, and these will be carefully explained to you. The knowledge gained from this study could help future patients with NASH. It’s important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Italy
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Unverified
Spain
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Unverified
Germany

Common questions

What is NASH?

NASH (Non-alcoholic steatohepatitis) is a liver condition where fat builds up, causing inflammation and damage, which can lead to scarring over time.

What does 'fibrosis' mean?

'Fibrosis' means scarring in the liver. In someone with NASH, this scarring can get worse over time if the condition isn't managed.

What is a 'placebo'?

A placebo is a dummy treatment that looks just like the real medicine but contains no active ingredients. It helps researchers compare the true effect of the drug.

Why is this study looking at a specific gene marker?

Some genes can affect how NASH develops. This study focuses on a specific gene marker because it's linked to a higher risk of more advanced liver disease, helping to target the research.

How long will I be involved in the study?

The treatment part of the study will last for 52 weeks (about a year), with follow-up appointments afterwards. The full commitment will be explained by the study team.