What is a clinical trial?
Clinical trials are research studies that test how well new medical approaches work in people. Before an experimental treatment can be tested on human subjects in a clinical trial, it must have shown benefit in laboratory testing or animal research studies. The most promising treatments are then moved into clinical trials, with the goal of identifying new ways to safely and effectively prevent, screen for, diagnose, or treat a disease.
What are the phases of clinical trials?
Clinical trials are conducted in a series of steps or phases. Each phase of a clinical trial has a different purpose.
- Phase I: Researchers test a drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, dosage range, and side effects.
- Phase II: The new drug or treatment is given to a larger group of people (100-300) to evaluate its effectiveness and further study its safety.
- Phase III: The new drug or treatment is given to large groups of people (1000 – 3000) to confirm its effectiveness, monitor side effects, compare it to similar treatments, and collect information to allow for its safe use.
If the experimental treatment works well in a Phase III trial, researchers can submit an application to the U.S. Food and Drug Administration (FDA) asking permission to make the treatment available to the public.
Why should I consider participating in a clinical trial?
People take part in clinical trials for many reasons. When you volunteer to participate in a clinical trial you help researchers learn more about curing, preventing, and treating liver disease and its complications, as well as improve healthcare for people in the future. In addition to helping others you get extra care and monitoring from the clinical trials staff and may receive the newest treatments for a disease.
Clinical trials are required to follow the same ethical and legal guidelines as standard medical practice to protect the safety of participants. However, before participating in a clinical study it’s important that you talk to your healthcare provider and learn about the study’s potential risks and benefits.
If you’re thinking about participating in a clinical trial and would like more detailed information, the NIH Clinical Trials and You website is an excellent resource.
Where can I find out about current clinical trials for NAFLD and NASH?
There are a number of ways to find information about specific trials in your area:
- The American Liver Foundation features an online search tool (see below – powered by Antidote, a digital health company that connects patients with research), that matches liver disease patients with clinical trials.
- ClinicalTrials.gov is a comprehensive database – provided by the U.S. National Library of Medicine – of publicly and privately funded clinical studies being conducted in the U.S. and around the world. You can search for actively recruiting studies on NAFLD and NASH or learn about new interventions and treatments that are being studied.
- Ask your healthcare provider about clinical trials that you may be eligible to participate in.
- Contact local medical institutions to learn about upcoming clinical trials in your area.
- Speak with our information specialists at the American Liver Foundation’s National HelpLine by calling 1-800 GO LIVER (1-800 465-4837) or chat with us through the live chat function on our website.
Find a Clinical Trial
Participating in a clinical trial is a great way to contribute to curing, preventing and treating liver disease and its complications. Start your search below to find clinical trials that need people like you.
Start your search:
- Find clinical trials by using our search tool above (powered by Antidote)
- Click “START” to begin
- On the next screen, enter the name of the liver disease and answer specific demographic data (such as city / distance / age)
By selecting “START” below, you will be leaving ALF’s website and accessing your search results on Antidote’s website. The American Liver Foundation does not endorse and is not affiliated with any of these trials.
What treatments are on the horizon for NAFLD and NASH?
The National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) and other branches of the National Institutes of Health (NIH) conduct and fund research into many diseases, including liver disease. Researchers are studying many aspects of NAFLD and NASH, such as:
- Testing drugs to treat NASH
- Building databases of adults and children who have NAFLD
- Studying how weight-loss surgery affects NAFLD in adolescents
While there are currently no medicines approved to treat nonalcoholic fatty liver disease, a few are being studies with promising results. The following medications are in Phase lll clinical trials for treating NASH and its complications:
- Obeticholic acid
Speak with your doctor about the ongoing progress and results of these trials to get the most up-to-date information on new treatments.