Trial Eligibility Check

Non-alcoholic fatty liver disease

How do clinical trials fit into the treatment of fatty liver (NASH)?
Metabolic diseases

It is currently estimated that 1 in 5 people in the Western world suffers from fatty liver, which has become the most common liver disease in countries like Israel. But despite its high prevalence, there is no drug treatment that has been found to be effective in stopping the disease or curing it. The answer may be found in innovative clinical trials.

Our liver is not only one of the major organs in the body, but also has one of the most important functions.

The liver stems are responsible for processing many substances that enter our bodies – including the food and drink we consume – so that it filters out the potential toxins from the bloodstream. The liver is also essential for the digestive process by producing bile (which is stored in the gallbladder next to it).

In addition to these important functions, the liver is also responsible, among other things, for the balance of fats in our body. In some cases, it may accumulate fat in the liver cells – called hepatocytes – to the point of a disease called stasis (fatty liver disease).

The reason why this process occurs is not fully understood, but a number of risk factors can be pointed out that increase the chance of fat accumulation in the liver, including being overweight, obese, diabetic, or having high blood lipid levels, and hypertension.

The accumulation of fat makes it difficult for the liver to perform. Various conditions can lead to a fatty liver including significant and long-term alcohol consumption. Medicine distinguishes between the various factors and calls the common “fatty liver“, the one that is not caused by alcohol consumption, called NAFLD – short for Non-Alcoholic Fatty Liver Disease.

A more advanced condition of fatty liver is called NASH – short for Non-Alcoholic SteatoHepatitis. About 20% of patients with fatty liver are in this advanced condition.

NASH may not cause any symptoms and therefore may not affect the quality of life for a long period of time. Without effective treatment to prevent its progress, however, it can cause severe and irreversible damages.

In NASH, the accumulation of fat causes local inflammation in the liver (hepatitis), which can later cause long-term damage, including scarring of the liver and in extreme cases also cirrhosis of the liver (a condition in which scar tissue replaces large parts of the functioning liver).

1. Key facts

Most patients are diagnosed with fatty liver in their 40s and 50s.

Between the 90s and 2000s, the incidence of the disease doubled.

Fatty liver is associated with the metabolic syndrome – a collection of signs related to obesity, hypertension and disturbance fats and sugars balance.

Currently, there is no recommended diagnosis test for the detection of fatty liver.

One of the reasons why a diagnosis test is not performed is that there is no effective treatment.

Despite its high prevalence, there is no drug treatment that has been found to be effective in stopping the disease or curing it. The answer may be found in innovative clinical trials – Check your eligibility here.

2. Diagnosis

In the absence of symptoms in the early stages of the disease, most cases of fatty liver come to medical attention following routine laboratory tests that test the liver functions.

Simple blood tests can detect elevated levels of liver enzymesAST and ALT (both also called aminotransferases). These are proteins that are normally found inside the liver cells, but are released into the bloodstream when there is damage to these cells, as occurs in inflammation for example.

NASH’s final diagnosis requires an ultrasound – an imaging test. The purpose of the imaging is to non-invasively examine the liver tissue, with an image of the fatty sieve in the liver being used.

Additional imaging such as CT Scan or MRI can also be used for diagnosis.

In some cases, a direct sample of the liver tissue is taken – a liver biopsy. Because it is an invasive procedure, not all patients undergo a liver biopsy, but only in accordance with the medical judgment of their attending physician. However, this is the most reliable test to differentiate between NAFLD and the more advanced condition – NASH.

After the diagnosis of NASH with the help of a biopsy, a follow-up with a non-invasive imaging is usually necessary. The frequency and nature of the follow-up is determined, among other things, by the severity of the disease.

3. Treatments
Pros and Cons.

The first treatment for many of those who suffer from fatty liver is weight loss. Even overweight patients who lose about 7-10% of their body weight can see an improvement in the inflammatory and scarring condition of their liver tissue in the case of NASH.

However, quite a few patients find it difficult to make comprehensive enough changes in their lifestyle to achieve this goal. The place of bariatric surgeries (such as gastric bypass) is constantly being examined, and today they seem to help some patients achieve the required weight loss. Therefore it may be considered for some patients that are suitable for surgery.

The options available as a drug treatment for fatty liver are quite limited. Medication can only be given to some NASH patients with a relatively advanced degree of liver scarring (fibrosis).

For fatty liver patients with advanced non-diabetic scarring, one of the treatments that has shown some efficacy is vitamin E. Evidence for the effectiveness of treatment is mixed, but there are studies that have shown that it improves the processes of inflammation and scarring.

For NASH patients who also have diabetes it is possible to use specific drugs that are used in the indication to treat diabetes, as they also seem to have a beneficial effect on the process of inflammation and scarring in the liver. The main drug that has been shown to be effective for both of these conditions is Actus® (Pioglitazone), which is currently rarely used in diabetes due to its side effects.

Victo® (Liraglutide), given by injection, has also been shown to be effective in studies for the combination of diabetes and NASH patients. This is a relatively new drug and therefore the degree of efficacy for this indication is still under examination.

The options available as a drug treatment for fatty liver are quite limited.

4. Next step
Many patients diagnosed with fatty liver are not even aware of their condition.

Because the disease progresses slowly and does not necessarily show symptoms until a late stage, which can sometimes be too late, many patients go on with their lives without devoting the necessary medical attention to the disease.

Prolonged inflammatory condition of the liver can be life-threatening, as it increases the chance of cirrhosis of the liver and liver failure, as well as liver cancer.

Changing lifestyles, even if it is extremely important to achieve a healthier quality of life, is not always easy. Sometimes it is not possible at all.

All of these reasons – along with the sharp rise in the incidence of fatty liver in the Western world in recent years – are leading more and more researchers and physicians in the search for more effective and safer treatments for NASH patients. After proving efficacy and safety in earlier studies, the new treatments are being tested in clinical trials.

Changing lifestyles, even if it is extremely important to achieve a healthier quality of life, is not always easy. Sometimes it is not possible at all.

5. Clinical trials
Clinical trials in Israel for fatty liver (NASH – NAFLD).

In Israel, there are several clinical trials that allow access to innovative treatment under close medical supervision and free of charge. The clinical trials focus mainly on cirrhosis of the liver and are performed in a number of medical centers in Israel. These experiments try to slow down the disease and prevent adverse events that can be caused by the disease. The length of the experiments varies from weeks to years.

To better understand how clinical trials are conducted, you can read about them on our website.

After clicking the “Match Me A Trial” button and answering a to short questionnaire, we can check if there is currently a clinical study that is right for you. Our team will then help you better understand how you can benefit from clinical research, what are the possible disadvantages, and how the research will be conducted.