About the MIRNA study

There is currently no medical treatment available for NASH with fibrosis.1 The MIRNA study will investigate the potential benefits of two different study drugs (both taken by mouth) for the treatment of NASH with liver fibrosis (initial stage liver scarring).

This website will give you an overview of the MIRNA study and you can run a quick check to see if you could be eligible to join, should you decide the study is right for you. If you have any further questions, please contact your doctor.

What is involved

During first visits to the study center we will ask you about your medical history and any medication you are taking. We'll also carry out some initial health assessments including physical examinations, an ECG test and a FibroScan® ultrasound to assess the condition of your liver (some study participants may also have an MRI scan). Blood and urine samples will be taken and you will be asked to answer some questions about how much alcohol you drink.

Following this, if the study team determines the MIRNA study might be a good fit for you, there will be a clinic visit to have a liver biopsy, where a small sample of your liver will be taken for analysis; this is needed to confirm whether you have NASH with fibrosis and can take part in the study.

The treatment phase of the MIRNA study lasts for 50 weeks. Throughout this time, you will need to take 3 tablets, twice a day with meals. You will visit the study center 12 times for various health assessments and have 4 telephone contact visits. You will have a second liver biopsy at the final visit of the treatment phase.

Your health will be monitored closely during the study. You will be given a Dosing Instructions and Diary booklet to record taking your twice daily dose of the study drugs and any symptoms or side effects you experience.

Are there any risks involved in taking part in the study?

Taking any medication carries risks and the study drugs are no different in this respect. It is possible that you may experience side effects or gain no benefit from the study drugs. It is also possible that side effects could occur as a result of study procedures such as liver biopsies, ECGs, ultrasound or MRI scans or when blood samples are taken.

References:

1. Chopra S. Patient education: Nonalcoholic fatty liver disease (NAFLD), including non-alcoholic steatohepatitis (NASH) (Beyond the Basics). UpToDate.com. Available at: https://www.uptodate.com/contents/nonalcoholic-fatty-liver-disease-nafld-including-nonalcoholic-steatohepatitis-nash-beyond-the-basics Accessed March 2020.