Summary:
Do you have a fatty liver? Maybe it’s time to consider a different path.
Many people who are overweight or who have diabetes, prediabetes, or high cholesterol may also have liver damage without knowing it. Nonalcoholic steatohepatitis (NASH) is a liver disease that occurs when a buildup of fat in the liver causes irritation (inflammation) and damage that may interfere with how the liver works. Many people with NASH feel fine and do not even know they have the condition.
If you have been told that you have or may have either NASH or a fatty liver, and diet and exercise haven’t worked, you may want to consider participation in the VIA clinical research study.
What is the purpose of the VIA clinical research study?
The VIA study is evaluating whether a once-daily, oral investigational medication called volixibat, is tolerable, safe, and effective in reducing liver damage in people with NASH. The study will evaluate the effects (if any) of three different doses of volixibat in patients with NASH.
What is the investigational medication?
The investigational medication in the VIA study is called volixibat, which is a capsule taken once-daily by mouth.
In this study, three different doses of volixibat will be compared to placebo, a capsule which looks like volixibat but contains no active ingredients. Participants in the study will be randomly assigned (like drawing names out of a hat) to receive either placebo or volixibat. The study will evaluate whether volixibat may help reduce liver damage in people with NASH. Volixibat is considered investigational because it is not approved by health authorities, including the U.S. Food and Drug Administration (FDA), for the treatment of NASH.
Who can participate?
You may be eligible to join the VIA study if you:
- Are 18 to 80 years old
- Do not have any liver disease other than NASH (such as hepatitis B or C)
- Do not have cirrhosis
- Do not have uncontrolled diabetes (HbA1c 9.0% or higher)
There are other eligibility criteria that you must meet in order to participate. The study staff can discuss these criteria with you in greater detail.
What will study participants be asked to do?
If you decide to participate in the VIA study, you will visit the study site 10 times over the course of up to 60 weeks.
If you qualify for and decide to participate in the VIA clinical research study, you will also be required to:
- Take your study medication once daily before your first meal of the day
- Carry your patient identification card with you all the time and show it whenever you consult a doctor or other healthcare professional
- Provide urine and blood samples
- Have liver biopsies
- Have MRI scans of your liver
- Follow all directions from the study staff
What are the potential study risks and benefits?
The study staff will explain all of the potential risks and benefits of participation. Before choosing to take part in the study, read all the information the study staff provides and ask questions about the study. The study staff can answer any questions you may have about study procedures or potential risks and benefits of study participation.