Do you have NASH?
Consider participating in the NN9500-4656 study evaluating three investigational drugs for their ability to treat Non-Alcoholic Steatohepatitis (NASH).
Join NN9500-4656 for up to 19 months of expert care where your health is in focus.
Key facts about NASH
The liver is an essential organ in the human body. We cannot live without it, so it is important to take good care of your liver.
Liver diseases can be difficult to detect since they are often silent, meaning they will not show any symptoms. NASH is a chronic and progressive disease caused by fat deposition in the liver, which causes inflammation and damage of the liver. If not treated, NASH can develop into cirrhosis, liver failure and cancer, which are all severe diseases.
It is unknown why some people develop NASH and others don’t, but people with certain medical conditions such as Type 2 diabetes, obesity and high cholesterol are at a higher risk of developing NASH.
Currently, there are very limited options for treating NASH.
What is the NN9500-4656 study?
In the NN0500-4656 study, we will investigate if a combination of two medicines called NNC0194-0499 and semaglutide can reduce liver damage in patients with Non-Alcoholic Steatohepatitis (NASH). NNC0194-0499 is a new medicine that works in the liver but in a different way than semaglutide. Semaglutide is a well-known medicine already used by doctors to treat Type 2 diabetes in many countries. It may also reduce liver damage and prevent future liver complications. The two medicines together may work better than each one separately.
The study will also assess a combination of semaglutide and another medicine called NNC0174-0833. Semaglutide and NNC0174-0833 cause weight loss, and this may reduce liver damage.
By joining the NN9500-4656 study, you will join a big worldwide community of approximately 672 participants, for up to 19 months. You will not be alone!
Each week, you will get two injections. These could be two of the three medicines, one of the medicines and a placebo, OR two placebo injections. (A placebo is a “dummy” medicine that looks like a real medicine, but doesn’t contain any active medicine.) The treatment you get is decided by chance. You would attend visits at the doctor clinic, and have phone visits with your study staff for up to 19 months. Your chance of getting at least one active medicine is 6-in-7.
What are the study medicines?
NNC0194-0499 is similar to a hormone produced in the liver called fibroblast growth factor 21 (FGF21). FGF21 regulates body fat. NNC0194-0499 is expected to have similar effects to FGF21.
FGF21 regulates body fat by:
- Increasing the removal of fat from blood.
- Removing fat from the liver.
- Decreasing scarring in the liver.
- Possibly decreasing inflammation in the liver.
Semaglutide is a medicine working similarly to a natural hormone called glucagon-like peptide-1 (GLP-1). GLP-1 acts like the hormone to:
- Help the body produce more insulin.
- Help the liver make less sugar (glucose).
- Help your stomach feel full and reduce your appetite.
Research has shown that semaglutide helped patients with Type 2 diabetes and helped patients lose weight.
NNC01174-0833 is a medicine working similarly to the hormone amylin that is naturally made in your body. It acts like the body’s own hormone, which helps your stomach feel full.
All three study medicines are thought to have a beneficial effect on NASH.
Most common side effects
Not everyone will experience side effects. The most commonly reported side effects for all three study medicines are stomach and gut problems. These may include feeling sick (nausea), being sick (vomiting) and diarrhea. You can get more information about the side effects from the study staff.
How can I be part of the NN9500-4656 study?
You may qualify to participate in the NN9500-4656 study if:
- You are 18 years of age or older.
- You are willing to undergo liver biopsies.
- You are able to attend regular clinic visits and receive phone calls over a 19-month period.
Benefits of participating in a clinical study
There are several potential benefits to taking part in the NN9500-4656 study. For example, you can:
- Understand your disease and take better care of your liver.
- Take an active role in your overall health.
- Help others by contributing to medical research.
Millions of people participate in clinical studies every year. By choosing to participate in a clinical study, you can make a difference in your life and the lives of others.
How can I get involved?
If you meet the listed eligibility criteria and would like to learn more about the NN9500-4656 study, we would love to hear from you! To speak with the clinical research coordinator, please call (318) 525-3233.