Intercept Pharmaceuticals is conducting a Phase III research study designed to study the effect of the investigational drug obeticholic acid (also known as OCA or INT-747) on the overall health and quality of life of patients with Nonalcoholic Steatohepatitis, also known as NASH, and evidence of liver fibrosis.
NASH is liver inflammation and damage caused by a buildup of fat in the liver. It is an increasingly common chronic liver disease closely associated with diabetes and obesity. NASH is part of a group of conditions called nonalcoholic fatty liver disease (NAFLD) or "fatty liver”. As NASH progresses it results in liver fibrosis (damaged and scarred liver tissue) which may lead to cirrhosis, liver failure and the need for liver transplantation. Currently, there are no therapies approved for the treatment of NASH. To prevent or slow disease progression, physicians commonly recommend lifestyle changes including diet and exercise.
The investigational drug, OCA, is a modified (man-made) version of a compound in the liver called a bile acid. Bile acids are used by the body to help with digestion and have additional effects on liver function. The purpose of this study is to find out how safe and effective OCA may be in delaying specific medical conditions or health related issues that can occur in patients with NASH and evidence of liver fibrosis.
In this research study, eligible NASH participants will be assigned to receive the investigational drug OCA or placebo. The study treatment will be assigned randomly (like flipping a coin) with two-thirds of the participants assigned to OCA (either 10mg or 25mg) and the other one-third to placebo. Neither the participant nor the doctor will know what study treatment has been assigned. Both OCA and Placebo will be given as a pill(s) to be taken once a day.
During this study, all participants will remain on study and continue to receive OCA or placebo until the study is completed. It is estimated that patients will participate for a minimum of approximately 6 years. During this time, participants will be evaluated by the study team after the first month of treatment and once every 3 months through Month 18. Following the Month 18 visit, participants will be evaluated 2 times per year (every 6 months) for each additional year in the study.
You may be eligible to participate if you have been diagnosed with Nonalcoholic Steatohepatitis (NASH) and have some evidence of liver fibrosis. For more details about this NASH study, including a list of requirements to enter the study, visit clinicaltrials.gov. This study has the clinical trials identifier: NCT02548351
A total of about 2065 people are being recruited to participate in this study worldwide. To locate your nearest study center, please use our site locator. The study team will meet with you to discuss the study, review your medical and NASH history and perform screening tests to determine if you are eligible to participate.