Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Effects of extensive Weight loss on Insulin resistance and Lipid-kinetics in people with obesity and fatty liver Disease

This research study, using the drug Wegovy, is designed for women aged 18 and over who have obesity and non-alcoholic fatty liver disease. It's a 'Phase IV' study, meaning the drug is already approved and the study aims to understand more about its long-term effects in the real world. Researchers will particularly focus on how weight loss from Wegovy affects the fat levels in the blood (VLDL-TG kinetics) and how much fat is in the liver after about eight months. They want to see how these changes are linked to the amount of weight lost and the amount of fat measured in the liver using special scans.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Region Midtjylland

Enrolment target

Start

28 Aug 2023

Obesity

What is this study about?

This study is looking at how a medicine called Wegovy affects people who are overweight or obese and also have a condition called non-alcoholic fatty liver disease. Fatty liver disease means there's too much fat built up in the liver, which can lead to health problems over time.

Wegovy is a treatment that helps people to lose weight. This study aims to understand exactly what happens inside the body when people lose weight using Wegovy. Specifically, researchers will be looking closely at how the body handles fats in the blood and how much fat is in the liver, after people have been taking the medicine for about eight months and their weight has become steady.

They want to find out if losing weight with Wegovy helps to reduce the amount of fat in the blood and liver. The study will also explore other important health markers, like how the body uses sugar, levels of inflammation, and even changes in the gut. This information will help doctors better understand the wider benefits of weight loss with Wegovy for people with these conditions.

Key takeaways

This study investigates Wegovy for obesity and fatty liver.
It focuses on how weight loss affects fat in the blood and liver.
Only women aged 18 and above are eligible.
The study measures changes after about 8 months of treatment.
It's a 'real-world' study, as Wegovy is already approved.

Who may be eligible?

This study is specifically looking for women who are 18 years old or older. There is no upper age limit, so women of any adult age can be considered.

To be eligible, you must have both obesity (meaning you are significantly overweight) and non-alcoholic fatty liver disease. This is a common condition where too much fat builds up in your liver, but it's not caused by drinking too much alcohol.

These are just the basic requirements, and a doctor involved in the study would need to check other health details to confirm if it's right for you.

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.

Am I a woman?
Am I 18 years old or older?
Have I been diagnosed with obesity (being significantly overweight)?
Have I been diagnosed with non-alcoholic fatty liver disease?

Answer every question to see your result.

What does participation involve?

The study will involve taking part over several months, likely around eight months, as that's when the main measurements will be taken after your weight has stabilised. During this time, you would be prescribed Wegovy injections using a pre-filled pen. You would also have regular check-ups and assessments, including special scans to measure fat in your liver (MRI-PDFF), and blood tests to look at various levels of fats, sugar, and other markers in your body. There will also be other tests to check your overall health, and potentially assessments of your muscle and gut health, to see how Wegovy affects your body in different ways.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a known weight-loss medication and close health monitoring, which could lead to improved health outcomes related to obesity and fatty liver disease. As with any medication, there can be potential risks or side effects from taking Wegovy. These would be fully explained by the study team. 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
Denmark

Common questions

What is Wegovy?

Wegovy is a medicine given by injection, designed to help people lose weight.

What is fatty liver disease?

It's a condition where too much fat builds up in your liver, not caused by heavy alcohol use.

Will I have to pay for the medication?

As part of the study, the medication would typically be provided without cost to you, but this should be confirmed with the study team.

How long will the study last?

The main part of the study focuses on changes after about eight months, but the total duration of your participation would be explained by the researchers.

What does a 'Phase IV' study mean?

It means the drug is already approved and available, and researchers are gathering more information about its effects and benefits in real-world use.