Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Effect of orlistat on LIVER fat content in obese subjects with NAFLD and High concEntrAtion of pLasma proneurotensin THrough inhibition of neurotensin secretion and action

This research study is investigating the effects of a medication called Orlistat on people with a condition called non-alcoholic fatty liver disease (NAFLD). NAFLD means there's too much fat in the liver. The main goal is to see if Orlistat can reduce the amount of fat in the liver over a 6-month period. Researchers will compare those taking Orlistat to a group not taking it. They will also look at whether Orlistat helps with other important health measures like body weight, how the body handles sugar (insulin sensitivity), blood sugar levels, cholesterol, and blood pressure. The study is in an early stage (Phase II), meaning it's exploring if the treatment works and is safe.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Region Skane

Enrolment target

Start

26 Jan 2023

What is this study about?

This research is looking into a condition called non-alcoholic fatty liver disease, often shortened to NAFLD. This simply means there is extra fat stored in the liver, and it's not caused by drinking too much alcohol. Our livers play many important roles in our bodies, and having too much fat in them can sometimes lead to health problems.

The study wants to find out if a medicine called Orlistat can help to reduce this extra fat in the liver for people who are also overweight or obese. Orlistat is a medicine that helps your body absorb less fat from the food you eat. Researchers want to see if taking Orlistat for six months can make a difference to the amount of fat in the liver, compared to people who don't take it.

Beyond just the liver fat, the study will also check other important health markers. This includes looking at changes in body weight, how well the body uses sugar, blood sugar levels, different types of cholesterol, and blood pressure. By studying these factors, the researchers hope to get a clearer picture of how Orlistat might help people with NAFLD.

Key takeaways

The study is looking at how Orlistat affects liver fat in people with NAFLD.
It will run for approximately six months.
Researchers will also check effects on weight, blood sugar, and cholesterol.
This is an early-stage study to see if Orlistat is helpful for this condition.
Participation involves taking capsules and attending regular clinic visits.

Who may be eligible?

To join this study, people must be at least 18 years old. There is no upper age limit, meaning older adults can also take part if they meet the other requirements.

Both men and women are welcome to participate. The study is open to anyone who fits the basic age criteria and has non-alcoholic fatty liver disease.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have non-alcoholic fatty liver disease (NAFLD)?
Are you generally healthy enough to take part in a clinical study?
Are you comfortable with regular clinic visits and providing blood samples?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medication, Orlistat, in capsule form, or a placebo (a dummy pill that looks the same but contains no active medicine). You would take these capsules as instructed. You would have a number of visits to the clinic over a period of 24 weeks (about six months). During these visits, the research team would carry out various assessments. These assessments would likely include measurements of your liver fat, weight, blood tests to check blood sugar and cholesterol levels, and blood pressure readings. After the 24 weeks of active treatment, there might be some follow-up appointments to see how you are doing. The total duration of your active participation in the study would be approximately six months.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as closely monitoring your health and possibly improving your liver fat and other health markers if Orlistat is effective. However, there are also potential risks, including possible side effects from the medication, which you would discuss in detail with the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden

Common questions

What is non-alcoholic fatty liver disease (NAFLD)?

NAFLD means there's too much fat in your liver, but it's not caused by drinking excessive amounts of alcohol.

What is Orlistat?

Orlistat is a medicine that helps your body absorb less fat from the food you eat.

What does 'Phase II' mean?

Phase II means this is an early stage of research, testing if the treatment works and is safe for this condition.

How long does the study last?

The main part of the treatment and monitoring for this study is 24 weeks, or about six months.

Will I definitely get Orlistat if I join?

You might get Orlistat or a dummy pill (placebo). This helps researchers fairly compare its effects.