Clinical trials are studies of investigational medications that are still in the development phase, with the goal of evaluating how they work in patients with a specific health condition. Clinical trials examine how safe and effective the study medication may be in helping improve a patient’s health.
NASH is a chronic condition in which the buildup of fat and inflammation in the liver may eventually lead to severe scarring called fibrosis. It is found in people who drink little or no alcohol. Patients with NASH typically experience no symptoms until the disease has caused advanced liver damage.
NASH occurs most often in people who have:
Pre-diabetes or type 2 diabetes
A history of being overweight or obese
High cholesterol or high blood pressure
It is more common in Hispanics than other ethnic groups.
Routine blood tests may indicate damage to the liver. However, in order to determine if you have NASH, a liver biopsy is necessary.
The most accurate way to diagnose NASH is with a liver biopsy. A liver biopsy is a common procedure in which a small sample of your liver is removed and examined under a microscope.
NASH is a serious form of Nonalcoholic Fatty Liver Disease, or NAFLD. If your doctor says you have fatty liver disease, you may also have NASH. Find out more by talking to your doctor.
Obeticholic acid (OCA) is an investigational compound currently being studied in patients with NASH and liver fibrosis.
By joining a clinical trial, you may have the opportunity to receive treatment that could improve your condition before it becomes widely available. You could advance understanding of a disease and better the lives of others like you.
However, some medications studied in clinical trials may not be helpful, or may have unwanted and/or potentially harmful effects.
If you join a clinical trial, you may receive a placebo instead of the study medication. A placebo is a pill or substance with no active ingredients, and is not expected to have any real medical effect.
Subject to local laws and regulations, participants may receive reimbursement for their time, travel and meal expenses.
Yes. You may leave a clinical trial at any time.
MedLine Plus: Interactive patient education tutorial on clinical trials at the National Library of Medicine's MedLine Plus web site. www.nlm.nih.gov/medlineplus
European Medical Association (EMA)
A searchable registry of federally and privately supported clinical trials conducted in the United States and around the world. The identifier for this NASH study is: NCT02548351 www.ClinicalTrials.gov
Use ClinTrialConnect to learn more about NASH and the REGENERATE study, communicate with study sites, and download and share resources with loved ones.