Non-alcoholic fatty liver study

Update May 2020: This study is now complete.  Thank you to everyone who participated and expressed interest.

This medicine (EYP001a) is being developed to see if it can help people with Non-Alcoholic Steato-Hepatitis (NASH). Steato-hepatitis is a type of liver disease known as fatty liver where excess fat is stored in the liver. NASH is a form of non-alcoholic fatty liver disease and is the most common chronic liver disorder. In addition to fat in their liver, patients with NASH have an inflammation of the liver, called hepatitis. Inflammation and liver cell damage can cause fibrosis, or scarring, of the liver, which may progress to cirrhosis and liver cancer. Currently no registered drug therapy exists for this disease.

EYP001a is a molecule that binds to the Farsenoid X receptor (FXR). This is a key regulator of bile, lipid (organic compounds including fats, oils, hormones, and certain components of membranes that are group together because they do not interact appreciably with water), and glucose metabolism (process which generally converts glucose to energy for cell utilization), which is, currently being studied as a new therapy for chronic hepatitis B virus (HBV) infection.

An increase of the activity of this receptor may help reduce liver steatosis (fatty liver), inflammation (redness, swelling, hot, and often pain of the liver) and fibrosis (abnormally large amount of scar tissue in the liver). This may help NASH patients by slowing liver disease progression and decreasing the need for of liver transplant.

The purpose of this study is to determine how safe and well tolerated EYP001a is in people with NASH (non-alcoholic fatty liver). The study will also look at how the body handles (distributes, breaks down, and eliminates) EYP001a (called pharmacokinetics – PK) and whether food might have an effect on how EYP001a is absorbed by the body. The effect that EYP001a has on the body will also be looked at by measuring certain substances (biomarkers and bile acid) in the body.

This clinical study is now complete and not recruiting new participants.

9 night stay with us

1 outpatient visit

* are aged 18 years to 75 years
* have been diagnosed with NASH
* have a body mass index ≥ 25 kg/m2 and ≤ 45 kg/m2.
* have not participated in any drug study with 60 days prior to first drug administration in the current study