Clinical Trials for NAFLD & NASH
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and other components of the National Institutes of Health (NIH) conduct and support research into many diseases and conditions, including liver diseases.
What are clinical trials for NAFLD and NASH?
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 (NAFLD) and nonalcoholic steatohepatitis (NASH). For example, researchers are
- building databases of adults and children who have NAFLD
- comparing how people with and without NAFLD process and metabolize food
- studying how weight-loss surgery affects NAFLD in adolescents
What clinical studies for NAFLD and NASH are looking for participants?
You can view a filtered list of clinical studies on NAFLD and NASH 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 NIH 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 and NASH 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 include
- 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 pioglitizone 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. More research is needed to determine whether OCA is a safe and effective treatment for NASH and to fully understand how OCA affects cholesterol.
This content is provided as a service of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health. The NIDDK translates and disseminates research findings through its clearinghouses and education programs to increase knowledge and understanding about health and disease among patients, health professionals, and the public. Content produced by the NIDDK is carefully reviewed by NIDDK scientists and other experts.