AuthorisedTherapeutic confirmatory (Phase III)Interventional

The effect of semaglutide therapy on hepatic fat content and on the acute reponse of liver fat to high-fat load in obese MASLD patients

This research trial is investigating the effects of a medication called semaglutide on liver fat in adult men who are obese and have a condition known as MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease). The main goals are to measure how much fat is in the liver after 14 and 16 weeks of treatment. We will also look at how the liver reacts to a high-fat meal both with and without added sugar. This will help us understand if semaglutide can help reduce liver fat and improve how the body handles fat. The study also explores other health markers like body weight, waist size, and body composition to get a full picture of the treatment's effects.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Institut Klinicke A Experimentalni Mediciny

Enrolment target

Start

02 Jun 2023

Obesity

What is this study about?

This study is looking into a medication called semaglutide and how it affects the amount of fat in the liver. We're focusing on men who are obese and have a condition called MASLD. MASLD means there's too much fat built up in the liver, which can lead to health problems over time. Semaglutide is already used for other health conditions, and now we want to see if it can help reduce this liver fat.

The main part of the study involves measuring the amount of fat in the liver. We'll do this using a special scan called magnetic resonance spectroscopy (MRS), which is a bit like an MRI scan and is very good at showing liver fat. These measurements will happen after 14 and 16 weeks of treatment with semaglutide. We also want to understand how the liver responds to fatty food. So, we'll give participants a high-fat meal (like cream) and measure their liver fat before and a few hours after. We'll also try this with a high-fat meal that includes some sugar, to see if that changes the liver's reaction.

Beyond liver fat, we'll also be checking other important health markers. This includes things like body weight, waist size, and body mass index (BMI). We'll also look at body composition, which means understanding how much of your body is fat versus muscle, and how much fat is just under your skin versus deeper inside your body. We'll also examine how well the body responds to insulin, which is important for managing blood sugar, and measure certain substances in the blood that might explain semaglutide's effects on the liver. All this information will help us understand the full impact of semaglutide on overall health in men with obesity and MASLD.

Key takeaways

The study focuses on adult men with obesity and liver fat (MASLD).
It aims to see if semaglutide reduces liver fat and improves liver response to fatty foods.
Liver fat will be measured using special scans (MRS).
Other health markers like weight, waist size, and blood tests will also be monitored.
The study lasts 16 weeks for each participant.

Who may be eligible?

This study is looking for volunteers who are adult men, aged 18 years or older, with no upper age limit.

To be included, you must have obesity and a condition called MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease). MASLD means you have too much fat in your liver.

There might be other health conditions or medications that would prevent you from joining, so it's important to discuss your full medical history with the study team.

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 an adult male?
Are you 18 years old or older?
Do you have a diagnosis of obesity?
Have you been diagnosed with MASLD (fatty liver disease)?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will receive the medication semaglutide. The study will last for 16 weeks. During this time, you will have regular visits to the clinic.

Key assessments will include special scans (magnetic resonance spectroscopy, or MRS) to measure liver fat, initially before you start the medication, and again after 14 and 16 weeks. You will also have tests to see how your liver reacts to a high-fat meal, both with and without sugar, measured before and after eating. Throughout the study, we will also regularly check your body weight, waist circumference, body composition using a special scanner, and take blood samples to measure insulin levels and other factors.

Potential risks and benefits

Taking part in this study might offer potential benefits, such as potentially reducing liver fat and improving other health markers. However, there's no guarantee you will experience these benefits. As with any medication, semaglutide can have side effects, and the study team will explain these to you in detail. You 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
Czechia

Common questions

What is MASLD?

MASLD stands for Metabolic Dysfunction-Associated Steatotic Liver Disease. It means there's too much fat in your liver, which can affect its normal function.

What is semaglutide?

Semaglutide is a medication that helps manage blood sugar and can also help with weight loss. This study is testing if it can reduce liver fat.

What is MRS?

MRS is a special type of scan, similar to an MRI, which is used to accurately measure the amount of fat in your liver without needing surgery.

Will I have to eat a lot of fatty food?

As part of the study, you will have some controlled tests where you consume a high-fat meal, and we will monitor your body's response. This isn't for an extended period, but for specific test days.

How long will the study last for me?

The active treatment and assessment period for participants in this study will be 16 weeks.