A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, and Pharmacodynamics of AZD4831 in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) with Fibrosis
This research study is looking at a new drug, AZD4831, for adults who have a liver condition called Non-alcoholic Steatohepatitis (NASH) with scarring. NASH is a type of fatty liver disease where there is inflammation and damage to the liver cells, which can sometimes lead to more serious liver problems over time. The main goal of this study is to check if AZD4831 is safe and how well people tolerate it. We also want to see if it can help reduce liver inflammation, measured by a blood test called ALT, after 12 weeks of treatment compared to a placebo (a dummy medicine). This is an early stage study to understand more about how the new medicine works.
At a glance
What is this study about?
This study is about a liver condition called Non-alcoholic Steatohepatitis, or NASH for short. NASH is a more serious form of fatty liver disease that affects about 2 to 3 out of every 100 people. If you have NASH, it means there's not only fat in your liver, but also inflammation and damage to your liver cells. Over time, this can lead to scarring (fibrosis) and potentially more severe liver problems like cirrhosis, liver cancer, or needing a liver transplant.
NASH is often linked to other health conditions like obesity, type 2 diabetes, and high cholesterol. The inflammation and damage in the liver happen because of how the body processes fats, especially in people with conditions like insulin resistance, where the body doesn't use insulin properly. This leads to fat building up and harming liver cells.
The researchers in this study are testing a new medicine called AZD4831. They want to find out if this medicine is safe for people with NASH and if their bodies cope well with it. A key part of the study is to see if AZD4831 can help reduce the amount of a substance called ALT in the blood. ALT is an enzyme that's released when liver cells are damaged, so lower levels often mean less liver inflammation and damage. This study is an important step in understanding if AZD4831 could be a helpful treatment for NASH in the future.
Key takeaways
- This study is for adults with NASH and some liver scarring.
- It's testing a new medicine called AZD4831 against a dummy medicine (placebo).
- The main goals are to check safety, how well people tolerate it, and if it reduces liver inflammation.
- Participation involves regular clinic visits and blood tests over 12 weeks.
- You have the right to leave the study at any time.
- This is an early-stage study to gather initial information about the new medicine.
Who may be eligible?
To join this study, you need to be an adult, at least 18 years old, and have a diagnosis of NASH with some scarring in your liver, but not severe scarring (cirrhosis).
The study team will carefully check your medical history, current health, and liver test results to make sure you fit all the requirements. This is important to ensure the study is safe for you and that the results are clear.
It's important to remember that this study is not for everyone with NASH. There will be specific medical reasons why some people cannot take part, for example, if they have other serious health conditions or are taking certain medications that might interfere with the study drug. All these details will be explained thoroughly by the study doctor.
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 NASH?
- Do you have some scarring in your liver (fibrosis), but not severe cirrhosis?
- Are you able to attend regular clinic appointments for 12 weeks?
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to receive either the new medicine, AZD4831, or a placebo. A placebo looks like the study medicine but contains no active drug. Neither you nor your study doctor will know which you are receiving, which helps make the study fair.
The study will involve regular visits to the clinic over a period of 12 weeks. During these visits, you will have blood tests to check your liver health (like ALT levels) and how your body is responding to the medicine. The research team will also monitor your safety closely, asking about any side effects you might experience. They will also take samples to measure the amount of the study medicine in your blood. After the 12-week treatment period, there will be follow-up appointments to ensure your continued well-being.
Potential risks and benefits
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Common questions
What is NASH?
NASH is a liver condition where there's not only fat but also inflammation and damage to your liver cells. It's a more serious form of fatty liver disease and can lead to liver scarring.
What is AZD4831?
AZD4831 is a new medicine being tested in this study to see if it can help reduce liver inflammation in people with NASH.
What is a placebo?
A placebo is a 'dummy' medicine that looks like the study drug but doesn't contain any active ingredients. It's used to compare against the real medicine.
How long will the study last for me?
The main part of the treatment will be for 12 weeks, with follow-up appointments after that.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your study doctor will know which you are receiving during the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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