Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Effects of NNC0194-0499 alone and in combination with semaglutide, of semaglutide alone, and of cagrilintide alone and in combination with semaglutide on liver damage and alcohol use in people with alcohol-related liver disease

This research is looking into new ways to help people whose livers have been damaged by drinking alcohol. Doctors are testing different new medications, either on their own or together, to see which ones might work best. The main aim is to find out if these medicines can reduce the damage to the liver. They will also be looking at whether the medicines can help people drink less alcohol. Some of the treatments being tested include new drugs called cagrilintide and semaglutide, which is already used for treating diabetes, alongside a dummy treatment (placebo) for comparison. The study is in an early stage, called Phase II, to explore how well these treatments work.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Novo Nordisk A/S

Enrolment target

140

Start

29 May 2024

alcohol-related liver disease

What is this study about?

This study is designed to explore whether new medications can help people who have developed liver problems because of their alcohol use. When someone drinks too much alcohol over time, it can harm their liver, leading to something called alcohol-related liver disease. The researchers are testing various treatments, including a new medicine called cagrilintide, another called semaglutide (which is already used for conditions like diabetes), and a combination of both. They are also using a 'placebo', which is a dummy treatment that looks like the real medicine but contains no active drug. This helps scientists compare the effects of the actual medicines.

The main goal is to see if these treatments can improve the health of the liver. The doctors will measure this by looking at specific indicators of liver damage, such as the amount of scarring (fibrosis) in the liver. They will also be checking other markers like liver stiffness, changes in fat in the liver, and levels of certain liver enzymes in the blood. These measurements help them understand if the treatments are making a difference to the liver's condition.

Beyond just the liver, the study will also investigate if these medications have any effect on a person's alcohol consumption. They will be measuring changes in how much alcohol people drink and checking a blood marker that indicates recent alcohol use. This comprehensive approach means the researchers can see if the treatments help tackle both the liver damage and aspects of alcohol use, while also keeping an eye on any side effects that might occur.

Key takeaways

This study is testing new medicines for liver damage caused by alcohol.
It aims to improve liver health and potentially reduce alcohol use.
Treatments include new drugs (cagrilintide, semaglutide) and a placebo.
It's a Phase II study, focusing on how well treatments work and their safety.
All adults (18+) are potentially eligible, regardless of sex.
Regular visits and tests would be required to monitor progress.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 years or older. The study is open to both men and women.

More specific details about your health and medical history will be needed to check if you're a good fit for this particular study. This is to make sure the study is safe for you and that the results are as clear as possible.

It's important to discuss any health conditions you have, or any medicines you are currently taking, with your doctor or the study team, as these might affect whether you can join.

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 a diagnosis of alcohol-related liver disease?
Are you comfortable making regular visits to a clinic for check-ups and tests?
Are you willing to potentially receive a placebo (dummy treatment)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely have regular visits to a clinic or hospital. During these visits, the study team would give you the study medication, which could be one of the new drugs, a combination, or a placebo. This would involve taking the medication as instructed, likely by injection, for a set period. You won't know if you're getting the active drug or the placebo.

To check how the treatment is working and ensure your safety, you would have several tests. These may include blood tests to check your liver health and other body functions, and special scans or tests to measure liver scarring, fat, and stiffness. The study team will also ask you questions about your alcohol use and general well-being. These visits and tests would happen over several months, with follow-up appointments after you finish taking the medication. The total duration of your involvement in the study would be explained to you in detail.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new treatment that could improve your liver health or reduce alcohol consumption, though there’s no guarantee it will work for you. You would also receive close medical attention and monitoring throughout the study. However, like all medications, the treatments being tested might have side effects, which could range from mild to more serious. The team will carefully explain all known side effects. You are always free to leave the study at any time, for any reason, without affecting your usual medical care.

Locations (10)

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

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Unverified
Germany
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Unverified
Greece
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Unverified
Bulgaria
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Unverified
France
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Unverified
Denmark
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Unverified
Czechia
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Unverified
Italy
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Unverified
Poland
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Unverified
Netherlands
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Unverified
Spain

Common questions

What is alcohol-related liver disease?

It's damage to the liver caused by drinking too much alcohol over time, which can make it hard for the liver to work properly.

What does 'Phase II' mean for a trial?

Phase II means it's an early stage of testing where doctors are mostly checking if the new treatments work and are safe, usually in a smaller group of people.

What is a placebo?

A placebo is a dummy treatment that looks like the real medicine but has no active drug. It helps doctors compare the real medicine's effects accurately.

Will I know which treatment I am getting?

No, in this type of study, you won't know if you're receiving the active drug or the placebo. This helps make the study fair and scientific.

What are 'liver enzymes'?

Liver enzymes are substances found in your blood that can show if your liver is damaged or inflamed. Doctors often check their levels to assess liver health.