Study on Orlistat’s Effect on Liver Fat in Obese Patients with Non-Alcoholic Fatty Liver Disease and High Proneurotensin Levels

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Orlistat on individuals with Non-Alcoholic Fatty Liver Disease (NAFLD). NAFLD is a condition where excess fat builds up in the liver of people who drink little or no alcohol. The study involves participants who are obese, meaning they have a body mass index (BMI) of 30 or higher, and have high levels of a substance in their blood called proneurotensin, which is linked to fat accumulation in the liver.

The purpose of the study is to determine if taking Orlistat for 24 weeks can significantly reduce the amount of fat in the liver compared to a control group. Participants will be randomly assigned to receive either Orlistat or a placebo. The study will last for about six months, during which participants will take the medication orally in the form of hard capsules. The main focus is to observe changes in liver fat content, but the study will also look at other health factors such as body weight, insulin sensitivity, blood sugar levels, and cholesterol levels.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The goal is to see if Orlistat can help reduce liver fat and improve overall health in people with NAFLD and obesity. This research could provide valuable insights into managing liver health and related conditions in the future.

1 joining the study

Upon joining the study, you will be required to provide written informed consent. This means you agree to participate after understanding the details of the study.

If you are a woman of childbearing potential, a negative pregnancy test is necessary before starting the trial.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes checking your age (20-65 years), body mass index (BMI) of 30 kg/m² or higher, and plasma concentration of pro-NTS greater than 150 pmol/L.

Your liver fat content (LFC%) will be measured to ensure it is above 5.6% without other causes of liver fat accumulation.

3 medication administration

You will be given Orlistat in the form of a hard capsule. The dosage is 120 mg, taken orally.

The medication is to be taken three times a day with each main meal that contains fat, for a duration of 24 weeks.

4 regular monitoring

Throughout the 24-week period, regular monitoring will occur to track changes in your liver fat content, body weight, and other health indicators.

These indicators include insulin sensitivity, fasting plasma glucose, plasma glucose after a glucose load, plasma triglycerides, LDL-cholesterol, systolic blood pressure, and HDL-cholesterol.

5 final assessment

At the end of the 24 weeks, a final assessment will be conducted to measure the changes in your liver fat content and other health indicators.

The primary outcome is the change in liver fat content from the start to the end of the study.

Who Can Join the Study?

Age between 20 and 65 years
Provide written informed consent, which means you agree to participate after understanding the study
For women who can have children, a negative pregnancy test is required
Body mass index (BMI) of 30 kg/m² or higher. BMI is a measure of body fat based on height and weight
Plasma concentration of pro-NTS greater than 150 pmol/L. Plasma is the liquid part of your blood, and pro-NTS is a specific protein measured in it
Liver Fat Content (LFC%) greater than 5.6% without other causes of liver fat than Non-Alcoholic Fatty Liver Disease (NAFLD)

Who Cannot Join the Study?

Having a medical condition other than Non-Alcoholic Fatty Liver Disease (a condition where fat builds up in the liver).
Not having a Body Mass Index (BMI) of 30 or higher. BMI is a measure of body fat based on height and weight.
Not having high levels of pro-NTS in the blood. Pro-NTS is a substance that can be measured in the blood.
Being part of a vulnerable population, which means needing special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Region Skane Skanes Universitetssjukhus	Lund	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	15.08.2023

Trial locations

Investigated drugs:

Orlistat

Orlistat is a medication used to help people lose weight. It works by blocking some of the fat that you eat, keeping it from being absorbed by your body. In this clinical trial, orlistat is being tested to see if it can reduce the amount of fat in the liver of people who are obese and have a condition called non-alcoholic fatty liver disease (NAFLD). The study is also looking at whether orlistat can affect a substance in the blood called proneurotensin, which is often found in higher levels in people with these conditions.

Non-Alcoholic Fatty Liver Disease – Non-Alcoholic Fatty Liver Disease (NAFLD) is a condition where excess fat builds up in the liver of individuals who consume little or no alcohol. It often occurs in people who are overweight or have diabetes. The disease progresses from simple fatty liver (steatosis) to a more severe form called non-alcoholic steatohepatitis (NASH), which involves liver inflammation. Over time, this inflammation can lead to scarring of the liver tissue, known as fibrosis. If fibrosis becomes severe, it can progress to cirrhosis, where the liver is permanently damaged. NAFLD is often associated with metabolic syndrome, which includes conditions like high blood pressure, high blood sugar, and abnormal cholesterol levels.

Trial ID:

2022-500366-10-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Orlistat’s Effect on Liver Fat in Obese Patients with Non-Alcoholic Fatty Liver Disease and High Proneurotensin Levels

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?