A Phase 1 open-label positron emission tomography TRIAL to assess changes in liver uptake of [68Ga]Ga-FAPI-46 following oral administration of single doses of AZD2389 to patients with advanced liver fibrosis (PECHORA)
Liver fibrosis happens when long-term damage causes thick, stiff scar tissue to build up in the liver. Over time, this scarring can stop the liver from working properly. This study is testing an experimental drug called AZD2389 to see how it affects the cells responsible for this scarring. Participants will take a single dose of the study medicine by mouth. Researchers will then use a specialised imaging scan, called a PET scan, to look inside the liver. The scan uses a tiny, safe amount of a radioactive tracer to highlight active scarring cells. Because this is an early Phase 1 study, the main goal is to find out if the drug reaches the liver and changes how these scar-forming cells behave. The findings will help doctors decide if the drug should be developed further as a potential treatment.
At a glance
What is this study about?
The liver is a vital organ that cleans your blood, helps digest food, and stores energy. When the liver is injured over many years—for example, by conditions like fatty liver disease, alcohol, or viral hepatitis—it tries to heal itself by laying down scar tissue. If this continues, it leads to advanced liver fibrosis, where tough scar tissue builds up and makes it harder for the liver to function normally.
Currently, there are very few treatments that can directly stop or reverse severe liver scarring. Researchers are developing a new tablet called AZD2389, designed to target the specific cells in the liver that produce scar tissue. To understand whether this medicine reaches its target and works properly, doctors need a way to look closely at these cells in living patients.
In this study, called PECHORA, researchers use an advanced imaging method called a PET scan alongside a special tracing dye known as [68Ga]Ga-FAPI-46. This dye attaches to active scar-making cells and lights up on the scan. By comparing scans before and after a single dose of the study drug, scientists can see if the medication changes how active those cells are. Although this study will not cure liver disease, the knowledge gained will help scientists design better treatments for liver fibrosis in the future.
Key takeaways
- Tests an early experimental medicine (AZD2389) for advanced liver scarring.
- Uses advanced PET scans to see how the drug affects active scar-forming cells.
- Participants take a single dose of the study tablet.
- Open to adults aged 18 and over with advanced liver fibrosis.
- A research study aimed at understanding the drug rather than providing a direct cure.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with advanced liver fibrosis. Men and women can both take part. Because it is an early study, doctors need to ensure that volunteers are stable enough to undergo the study scans safely.
People who have other severe, uncontrolled medical conditions or certain types of advanced liver failure may not be able to join. You may also be unable to take part if you cannot have PET scans or if you have had allergic reactions to similar imaging dyes in the past.
Because detailed medical criteria apply, a study doctor will carefully review your health records and perform standard health checks to confirm whether taking part is safe for you.
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.
- I am at least 18 years old.
- I have been diagnosed with advanced liver fibrosis (scarring of the liver).
- I am able to attend appointments at a hospital research clinic.
- I am comfortable lying still inside an imaging scanner for liver scans.
- I am willing to take a single dose of an experimental tablet and give blood samples.
What does participation involve?
Taking part in this study involves visiting a specialist hospital clinic. Before starting, you will attend a screening appointment where the study team will explain the trial, check your medical history, and carry out routine tests such as blood samples and physical checks to ensure the study is right for you.
During the study, you will receive a single dose of the study medicine, AZD2389, taken as a tablet by mouth. You will also have specialised PET scans of your liver. For these scans, a tiny amount of an imaging dye is injected into a vein, and you will lie still inside a scanner while pictures of your liver are taken. The scans help doctors see changes in liver scarring cells before and after taking the pill.
The team will monitor your blood pressure, heart rate, and blood tests to check your wellbeing. Follow-up visits or phone calls will be arranged to make sure you have recovered well. The total time commitment is usually across a few weeks, and travel expenses are typically supported by the study.
Potential risks and benefits
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Common questions
What is advanced liver fibrosis?
Advanced liver fibrosis is a condition where significant scar tissue has built up in the liver due to ongoing injury or inflammation, making the organ stiff.
Will taking part in this study cure my liver disease?
No. This is an early research study testing a single dose of a drug to see how it behaves, so it is not expected to cure your condition.
What is a PET scan?
A PET scan is a safe medical camera scan that uses a tiny amount of an imaging dye to create clear pictures of how cells are working inside your body.
Do I have to pay to take part?
No, you do not pay for any study medicine or scans. Clinical trials often offer help with travel costs to and from the clinic.
Can I leave the study if I change my mind?
Yes, you can withdraw at any time. Your normal medical care and relationship with your doctors will stay exactly the same.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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