Efficacy and safety investigation of NNC0194-0499 co-administered with semaglutide in subjects with non-alcoholic steatohepatitis: a dose-ranging, placebo-controlled trial.
This study is investigating new treatments for a liver condition called Non-Alcoholic Steatohepatitis (NASH). NASH is a type of liver disease where the liver becomes inflamed and damaged due to a build-up of fat, which can lead to scarring (fibrosis). Researchers are testing a new medicine (NNC0194-0499) alongside an existing medicine (semaglutide) to see if this combination can improve liver health and reduce scarring. They will also compare these treatments to a dummy medicine (placebo) to understand their effects. The main goal is to see if the treatments can improve liver scarring without making the NASH worse, and to check for any side effects.
At a glance
What is this study about?
This clinical trial is designed to investigate new ways to treat a liver condition called Non-Alcoholic Steatohepatitis, or NASH. NASH is a serious liver disease where a lot of fat builds up in the liver, causing inflammation and damage. Over time, this can lead to scarring, also known as fibrosis, which can affect how well the liver works.
In this study, researchers are testing a new medicine (NNC0194-0499) when given together with an existing medicine called semaglutide. They want to find out if this combination can help improve the liver scarring and overall condition for people with NASH. Some participants will receive the active medicines, while others will receive a 'placebo', which looks like the real medicine but contains no active ingredient. This helps researchers understand the true effect of the new treatments.
The main goal is to see if these treatments can reduce liver scarring and prevent the NASH from getting worse over about a year (52 weeks). They will also look at whether the inflammation and fat in the liver improve, and carefully monitor participants for any side effects to make sure the treatments are safe.
Key takeaways
- This study is testing new medicines for NASH, a liver condition.
- It aims to improve liver scarring and damage in people with NASH.
- It compares new treatments to a dummy medicine (placebo).
- The study lasts about one year and involves regular clinic visits.
- Safety and potential side effects will be carefully monitored.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women are welcome to participate.
There will be other specific health requirements that the study doctors will check to make sure the study is right for you. For example, they will need to confirm you have NASH and may need to check other health conditions you have, or medicines you are currently taking, to ensure they don't interfere with the study treatments or your safety.
The study team will discuss all the detailed requirements with you to see if you are a good fit for this research.
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 at least 18 years old?
- Have you been diagnosed with Non-Alcoholic Steatohepatitis (NASH)?
- Are you able to attend regular clinic appointments for about a year?
- Are you willing to potentially receive either the study medicine or a placebo?
- Are you comfortable with blood tests and other assessments to check your liver?
What does participation involve?
If you decide to take part in this study, you will be in the study for about 52 weeks (roughly one year). During this time, you will have regular visits to the study clinic. These visits will involve blood tests, physical examinations, and possibly other tests to check your liver health and overall well-being. You will be given either the study medication or a placebo, which you will take as instructed by the study team. They will teach you how to take your medicine correctly. The study team will be there to support you throughout the study, answer your questions, and monitor your health closely.
Potential risks and benefits
Locations (11)
- —UnverifiedGermany
- —UnverifiedFrance
- —UnverifiedItaly
- —UnverifiedDenmark
- —UnverifiedSpain
- —UnverifiedPoland
- —UnverifiedCzechia
- —UnverifiedBelgium
- —UnverifiedPortugal
- —UnverifiedBulgaria
- —UnverifiedGreece
Common questions
What is NASH?
NASH (Non-Alcoholic Steatohepatitis) is a liver condition where fat builds up in the liver, leading to inflammation and damage, which can cause scarring.
What is a placebo?
A placebo is a dummy treatment that looks like the real medicine but contains no active ingredients. It helps researchers understand the true effects of the study medicines.
How long will the study last?
The main part of this study will last for about 52 weeks, which is roughly one year.
Will I know if I'm getting the real medicine or the placebo?
No, in this type of study, neither you nor the study team will usually know who is receiving the active medicine and who is receiving the placebo until the study is over. This helps ensure the results are fair and unbiased.
Are there any costs for taking part?
Clinical trials typically cover the costs related to the study treatment and visits. Any personal expenses, such as travel, may be reimbursed, but you should confirm this with the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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