Nonalcoholic fatty liver disease (NAFLD) is the buildup of fat in the liver that is not related to alcohol consumption. Many people with NAFLD have diabetes or are overweight or obese. If left untreated, this disease can progress to nonalcoholic steatohepatitis (NASH), which causes liver inflammation and scarring (fibrosis).1
Currently, there are no medications approved for treating NAFLD and NASH — instead, doctors recommend lifestyle changes, including eating a healthy diet and exercising regularly. Treating any underlying health conditions associated with NAFLD can also help control the disease and prevent progression to NASH.2
As doctors and researchers continue learning more about NAFLD, they work toward developing new ways to treat it. Before these treatments can be made available to the general public in the U.S., they must first go through clinical trials. These studies are required by the U.S. Food and Drug Administration (FDA) to prove that the treatments are safe and effective. Doctors and researchers running clinical trials recruit participants with NAFLD to determine whether the therapies being studied help reduce fat levels in the liver and control inflammation.
The clinical trials discussed below are just some of the current studies exploring new ways of treating NAFLD.
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New NAFLD Treatments
The FDA has yet to approve any medications specifically for treating NAFLD or NASH. However, there are several experimental treatments currently being studied. Some of these medications focus on blocking fat buildup in the liver for treating NAFLD, while others may help reduce inflammation and fibrosis associated with NASH. These therapies may help treat cases where diet and exercise aren’t as effective.
Examples of experimental therapies currently being studied include:
- Ibutamoren: A peptide (small protein) that is also being studied for treating growth hormone deficiency in children; researchers also believe it blocks fat accumulation in the liver3,4
- AZD7503: A small piece of DNA that blocks instructions for making HSD17B13 protein in the liver, which plays a role in fat droplet formation5,6
- GSK4532990: A drug that blocks HSD17B13 and may improve inflammation and liver fibrosis in people with NASH7
- Lanifibranor: A drug that activates PPAR proteins in the liver, which may help reduce fat buildup and treat fibrosis in people with type 2 diabetes and NAFLD8,9
Lanifibranor has also been granted Breakthrough Therapy and Fast Track designations by the FDA.10 These designations are given to experimental therapies that treat serious diseases. They help fast-track the development and review to get new treatments on the market faster. It’s important to note that lanifibranor still needs to go through the proper clinical studies to show it’s safe and effective before being approved.11
Previously Approved Treatments
While experimental therapies offer new ways to treat diseases, doctors and researchers also look for ways to repurpose previously approved treatments for other diseases. To be marketed for NAFLD, these therapies must also go through clinical trials to ensure they’re safe and effective in a new setting.
Doctors already prescribe following a healthy diet and exercising regularly to help treat NAFLD. However, specific recommendations may help improve NAFLD and prevent NASH more than generalized ones, such as cutting back on fat and sugar. Clinical trials are currently investigating the benefits of time-restricted eating, which limits the time you eat throughout the day to an 8-hour period.12
Since many people with NAFLD also have diabetes, doctors and researchers are investigating the use of diabetes medications for treating NAFLD. These include SGLT2 inhibitors and glucagon-like peptide-1 analogues (GLP-1), which are currently approved for treating type 2 diabetes. Clinical trials are studying these medications in teenagers with NAFLD and obesity.13,14
Joining an NAFLD Clinical Trial
Find Clinical Trials Near Me
Interested in clinical trials? Simply search by postal code and type of condition to see what’s going on in your area.
If you or a loved one is interested in joining an NAFLD clinical trial, the best place to start is by looking for studies near you that you may be eligible for.
Doctors and researchers running clinical trials post their requirements for joining studies online. In order to join a study, you must meet the inclusion criteria or a specific set of requirements. Studies may also have exclusion criteria, which may limit you from participating. These criteria are set to help keep participants safe during a study and ensure the data collected are useful. For instance, to join an NAFLD clinical trial, you may have to:
- Meet certain age and health requirements
- Have elevated liver enzyme levels indicating liver damage
- Have a certain body mass index (BMI)
Volunteers join clinical trials for several different reasons — you may feel empowered to take control of your health, or you may be interested in advancing science and helping others with NAFLD. You may even experience benefits from an experimental treatment.
Choosing to take part in a clinical trial is a major decision. Whatever your choice is, it should be what’s best for you.