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What is NASH?

NASH stands for non-alcoholic steatohepatitis. NASH occurs when there is a build-up of too much fat in the liver, accompanied by inflammation and damage. It often occurs in people who have obesity and other health issues such as diabetes and high cholesterol. NASH has become more common. It is estimated that around 30% of the general population have excess fat in their liver and up to 30% of these people have NASH.

NASH is not caused by drinking alcohol excessively. However, under the microscope the liver damage can appear similar to that caused by high alcohol intake.

What does the liver do?

The liver is the largest internal organ and sits on the right-hand side of the belly. It is important for the liver to stay healthy because it has hundreds of functions. The liver turns the nutrients in our diets into important substances that the body needs. It also stores energy for use throughout the day and helps remove toxic substances from the body.

Am I at risk for NASH?

NASH is most common in people who are both middle-aged, especially over 50 years of age, and overweight or obese. However, people who look healthy with a normal weight can still have NASH, and the disease can even occur in children.

People who have type 2 diabetes, high cholesterol or triglycerides, or a combination of these health issues known as ‘metabolic syndrome’, are also more likely to develop NASH.

What are the symptoms of NASH?

You may have no symptoms in the early stages of NASH. Most people who have NASH feel fine and don't know that they have it.

As NASH progresses and liver damage gets worse, you may start to have these symptoms:

  • A general feeling of discomfort or lack of energy
  • An abdominal ache in the upper right part of your belly.

It may take many years for NASH to become severe enough to cause symptoms.

How can NASH affect my health?

NASH is a chronic disease, which means that it affects your health over the course of many years. If left unchecked, NASH can worsen, causing injury to and scarring of the liver. Eventually the liver may not be able to work properly and the damage may lead to liver cancer or death for some people. In the end stages, a liver transplant may be needed, though access to transplantation is severely limited and not guaranteed.

NASH also leads to a higher rate of death from heart disease and other illnesses.

What is the purpose of the study?

The purpose of this study is to investigate whether the study drug is safe and effective in patients with NASH. If you agree to participate in a study, you may get the (LJN452) study drug or a placebo (a dummy drug with no active medicine, like a sugar pill). The study will compare the effects of the study drug versus placebo.

Each study drug under investigation is a medicine that has not been approved by any health authority, including the FDA, for the treatment of people with NASH.  This means that it is not currently “on the market” (available for you to receive a prescription for and/or to buy) in any country.

Some of the benefits of being a patient in one of these clinical research studies include:

  • Helping others with the same medical condition by contributing to medical research
  • Gaining access to new research treatments
  • Having access to expert medical care for the condition being studied
  • Getting actively involved in your health care.

References: Dyson JK Non-alcoholic fatty liver disease: a practical approach to diagnosis and staging. Frontline Gastroenterol. 2014:5(3):211-218