FAQs

A clinical research study is a medical research study in people. The potential new treatment or device being studied only enters a clinical study after researchers test it in the laboratory. If it looks promising, scientists carefully test and collect data about the potential treatment through clinical studies. A clinical study helps us learn how an investigational treatment works in the body. Clinical studies must be reviewed by a regulatory agency. In the United States, it’s the Food and Drug Administration (FDA). Agencies vary by region. They decide whether to approve the investigational treatment for doctors to prescribe.
The first step is discovering and developing a new investigational treatment to study. After that, clinical studies show if it is safe and effective and provide information on any side effects. Sometimes, researchers compare the potential treatment to a placebo. The placebo looks and is administered like the potential treatment but has no active ingredients. The potential treatment may also be compared to a standard treatment that is already approved and used for treatment, to find out if the potential treatment is better.
If you join the study, there are certain things you will be expected to do. This includes attending study visits and undergoing certain assessments and procedures, such as blood draws, physical examinations, and liver biopsies. For more information regarding the study, visit the About NASHGEN-2 section. About NASHGEN-2
The study will last approximately 100 weeks.
You may benefit by receiving additional health check-ups on top of your regular medical care. You will also help us increase our medical understanding of NASH, which may benefit others in the future with this condition.
The Informed Consent Form (ICF) talks about all known risks. It is possible that there will be other risks associated with the investigational treatment that are unknown at this time. Before starting a clinical study, you must sign the ICF. Signing it means you agree to participate in the research study. The study staff will walk you through the study schedule and design. Ask questions so you are comfortable moving forward.
Clinical studies are 100% voluntary. You can stop at any time.
What do I do if I have other questions?
If you have additional questions about taking part in this study, you can share this website with your doctor to discuss this clinical research study. Additionally, you can also contact a clinical site near you: