Active not recruitingPHASE3INTERVENTIONAL

Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)

This research study is investigating whether a medicine called semaglutide can help people with a liver condition known as non-alcoholic steatohepatitis, or NASH. Semaglutide is a well-known medication already used by doctors to treat type 2 diabetes. Participants will be randomly given either semaglutide or a dummy medicine (placebo). The medicine will be given as a weekly injection under the skin that participants will administer themselves. The study is quite long, lasting about 5 years, and will involve around 21 visits to a clinic and 9 phone calls with the study team. People with other long-term liver conditions, or women who are pregnant, breastfeeding, or planning to become pregnant, won't be able to join.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Novo Nordisk A/S

Enrolment target

1,205

Start

01 Apr 2021

Estimated completion

25 Apr 2029

Non-alcoholic Steatohepatitis

What is this study about?

This study is about a medicine called semaglutide and its potential to help people with a liver condition known as non-alcoholic steatohepatitis, or NASH. NASH is a serious type of fatty liver disease that can lead to liver damage over time. Semaglutide is a medicine that many doctors are already using to treat type 2 diabetes. Researchers want to understand if this medicine could also be an effective treatment for NASH.

Taking part in this study means you would be helping doctors and scientists learn more about NASH and how best to treat it. The information gathered could help improve treatments for many people in the future. The study is comparing semaglutide against a 'dummy' medicine (called a placebo). This is a common way to test new medicines, as it helps researchers see if the study drug genuinely has an effect, or if improvements might be due to other factors.

It's important to remember that joining a study like this doesn't guarantee you'll receive the active medicine; you might get the placebo. However, all participants will receive careful medical attention and monitoring throughout the study. Your health and safety will be the top priority for the study team.

Key takeaways

This study is testing a diabetes medicine (semaglutide) for NASH.
It's a long study, lasting about 5 years.
You'll get a real drug or a dummy pill, decided by chance.
Regular weekly injections and clinic visits are required.
Close medical monitoring by the study team is part of taking part.
You can leave the study at any time if you change your mind.

Who may be eligible?

To be able to join this study, you need to be 18 years old or older. You will also need to have been diagnosed with NASH, which means a liver biopsy (a small sample of liver tissue) showed clear signs of the condition, including some scarring in your liver, usually referred to as fibrosis (stage 2 or 3).

There are certain reasons why you might not be able to join. For example, if you have other long-term liver diseases, or if you've had certain serious liver problems in the past like fluid build-up (ascites) or bleeding from veins in your food pipe (variceal bleeding). Also, if you currently have or have recently had infections like Hepatitis B, Hepatitis C, or HIV, you won't be able to take part.

Willingness to have an occasional alcoholic drink might prevent you joining if it's more than 2-3 small glasses of wine per day for men, or 1-2 small glasses for women. If you are pregnant, breastfeeding, or planning to become pregnant during the study, you also wouldn't be able to participate. Lastly, certain medicines like high doses of Vitamin E, pioglitazone, or other similar diabetes medications (GLP-1 RAs) within a specific timeframe before the study might make you ineligible, unless they have been taken at a stable dose for long enough.

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?
Have you been diagnosed with NASH, confirmed by a liver biopsy showing moderate scarring (fibrosis stage 2 or 3)?
Do you have any other long-term liver diseases (like Hepatitis B or C, or HIV)? (If yes, you may not be eligible.)
Are you pregnant, breastfeeding, or planning to become pregnant during the next 5 years? (If yes, you may not be eligible.)
Are you able to inject medicine under your skin once a week?
Are you willing and able to attend around 21 clinic visits and have 9 phone calls over 5 years?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it's a long-term commitment. The study itself will last for about 5 years. You'll need to inject yourself once a week with the study medicine (either semaglutide or the dummy medicine) under your skin. Don't worry, the study team will teach you exactly how to do this safely.

Throughout these 5 years, you'll have regular contact with the study team. This will involve around 21 visits to a clinic. Some of these visits might even take place over more than one day, so you'll need to factor that into your schedule. In between clinic visits, you'll also have about 9 phone calls with the study staff to check how you're doing. All these visits and calls are important for the team to monitor your health and how you're responding to the treatment.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. A potential benefit of this study is that you might receive semaglutide, which could help your NASH, or you might benefit from the very close medical monitoring and care provided by the study team. However, there's also a chance you'll receive the dummy medicine and not the active drug. Potential risks might include side effects from the medication, discomfort from injections, or the time commitment for visits. The study team will explain all known potential side effects of semaglutide. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (557)

North AL Health Res, LLC
Verified postcode
Huntsville, United States
The Institute for Liver Health
Verified postcode
Chandler, United States
Inst-Liver Hlth dba AZ Liver H
Verified postcode
Peoria, United States
Inst. Liver H II dba AZ Liver H
Verified postcode
Tucson, United States
Del Sol Research Management, LLC
Verified postcode
Tucson, United States
ARcare Center for Clinical Research
Verified postcode
Jonesboro, United States
ARcare Center for Clinical Research
Verified postcode
Little Rock, United States
Arkansas Diagnostic Center, PA
Verified postcode
Little Rock, United States
Gastroenterology & Liver Institute
Verified postcode
Escondido, United States
Shang Wu M.D. Inc.
Verified postcode
Hacienda Heights, United States
Scripps Whittier Diabetes Inst
Verified postcode
La Jolla, United States
UCSD NAFLD Research Center
Verified postcode
La Jolla, United States

Common questions

What is NASH?

NASH stands for non-alcoholic steatohepatitis. It's a type of liver disease where too much fat builds up in the liver, leading to inflammation and liver cell damage, which can cause scarring.

What is semaglutide?

Semaglutide is a medicine that's already used to treat type 2 diabetes. This study is testing if it can also help people with NASH.

Will I definitely get the active medicine?

No, you will be randomly assigned to receive either semaglutide or a 'dummy' medicine (placebo). You won't know which one you're getting.

How long will I be in the study?

The study will last for approximately 5 years, which is a long-term commitment.

Can women who are pregnant join?

No, women who are pregnant, breastfeeding, or planning to become pregnant cannot take part in this study.