Clinical Trials for NAFLD & NASH

The NIDDK conducts and supports clinical trials in many diseases and conditions, including liver diseases. The trials look to find new ways to prevent, detect, or treat disease and improve quality of life.

What are clinical trials for NAFLD?

Clinical trials—and other types of clinical studies —are part of medical research and involve people like you. When you volunteer to take part in a clinical study, you help doctors and researchers learn more about disease and improve health care for people in the future.

Researchers are studying many aspects of nonalcoholic fatty liver disease, or NAFLD (also referred to as metabolic dysfunction-associated steatotic liver disease, or MASLD).

• new treatments for NASH (also referred to as metabolic dysfunction-associated steatohepatitis, or MASH)
• how genes may increase the risk for NAFLD
• how liver diseases, such as NAFLD, develop and progress over time

Find out if clinical studies are right for you.

Watch a video of NIDDK Director Dr. Griffin P. Rodgers explaining the importance of participating in clinical trials.

What clinical studies for NAFLD are looking for participants?

You can view a filtered list of clinical studies on NAFLD that are federally funded, open, and recruiting at www.ClinicalTrials.gov. You can expand or narrow the list to include clinical studies from industry, universities, and individuals; however, the National Institutes of Health does not review these studies and cannot ensure they are safe. Always talk with your health care provider before you participate in a clinical study.

What have we learned about NAFLD from NIDDK-funded research?

The NIDDK has supported many research projects to learn more about NAFLD and NASH. For example, the NIDDK’s NASH Clinical Research Network (NASH CRN) has conducted studies to advance understanding of the causes, development, complications, and treatment of NASH in children and adults. NASH CRN studies have included

• Pioglitazone or Vitamin E for NASH Study (PIVENS). Researchers found that a daily dose of the natural form of vitamin E—the type of vitamin E that comes from food sources and is not synthetic (laboratory-made)—improved NASH in study participants overall. Pioglitazone also improved some features of NASH, although researchers couldn’t prove that the improvements did not occur randomly. Many study participants taking pioglitazone gained weight, and many participants did not improve from either treatment. More research is needed to determine whether treatment with vitamin E or pioglitazone causes long-term risks.
• Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC) trial. The TONIC trial found that the natural form of vitamin E—the type of vitamin E that comes from food sources and is not synthetic (laboratory-made)—improved the most severe form of fatty liver disease in some children. More research is needed to determine whether treatment with vitamin E causes long-term risks.
• The Farnesoid X Receptor Ligand Obeticholic Acid in NASH Treatment Trial (FLINT). FLINT found that obeticholic acid (OCA) treatment was associated with improved liver function in people with NASH. OCA was also associated with increases in itching and total cholesterol. These results led to a large worldwide study that is still being evaluated to determine whether OCA is a safe and effective treatment for NASH and to fully understand how OCA affects cholesterol.