RecruitingPHASE3INTERVENTIONAL

A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH

This research study is looking at a new medicine called efruxifermin for people who have liver scarring, known as cirrhosis, caused by NASH or MASH. NASH and MASH are types of fatty liver disease. We want to find out if efruxifermin can help improve the liver’s condition and prevent it from getting worse. Participants will either receive the new medicine or a dummy medicine (placebo) to fairly compare their effects. This is a large study happening in many different centres, and neither the participants nor their doctors will know who is getting which treatment until the study ends. This helps ensure the results are accurate and reliable.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Akero Therapeutics, Inc

Enrolment target

2,150

Start

04 Sep 2024

Estimated completion

01 Mar 2030

NASH - Nonalcoholic Steatohepatitis MASH - Metabolic Dysfunction-Associated Steatohepatitis

What is this study about?

This study is investigating a new medicine called efruxifermin. It's designed for people who have a liver condition known as cirrhosis. Cirrhosis means your liver has developed scars, and in this study, it's specifically due to NASH (Nonalcoholic Steatohepatitis) or MASH (Metabolic Dysfunction-Associated Steatohepatitis). These are types of fatty liver disease that can lead to inflammation and scarring over time. The main goal is to see if efruxifermin can help people with this specific type of liver scarring improve their liver health.

At this stage, the cirrhosis is described as 'compensated,' which means your liver is still working well enough despite the scarring, and you haven't yet developed severe symptoms or complications. This study is important because NASH/MASH cirrhosis is a serious condition, and finding effective treatments could make a big difference in people's lives by potentially slowing or stopping the progression of the disease and improving quality of life.

The study involves comparing efruxifermin with a placebo, which looks like the medicine but contains no active ingredient. This is a common and important way to test new medicines to ensure any improvements seen are genuinely due to the medicine itself and not just other factors. Participants will be randomly assigned to receive either the medicine or the placebo, and neither they nor their doctors will know which one they are receiving during the study. This helps ensure the study results are as fair and unbiased as possible.

Key takeaways

This study is for people with scarring of the liver (cirrhosis) caused by NASH/MASH.
It's testing a new medicine called efruxifermin to improve liver health.
Participants will receive either the new medicine or a dummy medicine (placebo).
Your liver must be 'compensated' – meaning it's still functioning adequately.
The study is for adults aged 18 to 80 years old.

Who may be eligible?

To join this study, generally, you need to be an adult between 18 and 80 years old. The study is open to both men and women. A key requirement is that you must have scarring of the liver, called cirrhosis, because of NASH or MASH. Your liver should still be working reasonably well, meaning your cirrhosis is 'compensated' and not causing severe complications yet. We will need to confirm this liver condition, either through a liver biopsy or other tests.

There are also some criteria that might mean you can't join. For example, if your liver disease is caused by something other than NASH or MASH, or if you have certain types of diabetes that are not well-controlled, you might not be eligible. Also, if you have ever had severe liver problems or complications from your cirrhosis in the past, this study might not be suitable 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.

Are you between 18 and 80 years old?
Do you have a diagnosis of liver scarring (cirrhosis) due to NASH or MASH?
Is your liver overall still working reasonably well ('compensated' cirrhosis)?
Have you *not* had severe liver complications from your cirrhosis in the past?
Are you able to attend regular clinic visits and follow study instructions?

Answer every question to see your result.

What does participation involve?

Information about what taking part involves hasn't been fully detailed here, but in similar studies, participation usually includes regular visits to a clinic. These visits might involve physical examinations, blood tests, and possibly other tests like scans or liver biopsies to monitor your health and how the medicine is working. You would be given the study medicine (either efruxifermin or placebo) on a regular schedule, as instructed by the study team. Throughout the study, medical staff would keep a close eye on your health. There would also be follow-up appointments after you finish taking the study medicine. The total length of time you'd be involved in the study would be explained to you in full detail by the study team.

Potential risks and benefits

Taking part in this study could offer potential benefits, such as contributing to scientific understanding of NASH/MASH cirrhosis and potentially improving your liver condition if you receive the active medicine. However, there are also potential risks, including possible side effects from the study medicine or discomfort from study procedures like blood tests or biopsies. It's important to remember you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (321)

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

Akero Clinical Study Site
Verified postcode
Birmingham, United States· Recruiting
Akero Clinical Study Site
Verified postcode
Dothan, United States· Recruiting
Akero Clinical Study Site
Verified postcode
Chandler, United States· Recruiting
Akero Clinical Study Site
Verified postcode
Flagstaff, United States· Active not recruiting
Akero Clinical Study Site
Verified postcode
Peoria, United States· Recruiting
Akero Clinical Study Site
Verified postcode
Scottsdale, United States· Recruiting
Akero Clinical Study Site
Verified postcode
Tucson, United States· Recruiting
Akero Clinical Study Site
Verified postcode
Tucson, United States· Recruiting
Akero Clinical Study Site
Verified postcode
Tucson, United States· Recruiting
Akero Clinical Study Site
Verified postcode
Tucson, United States· Recruiting
Akero Clinical Study Site
Verified postcode
Conway, United States· Active not recruiting
Akero Clinical Study Site
Verified postcode
Jonesboro, United States· Active not recruiting

Common questions

What is NASH/MASH cirrhosis?

NASH/MASH cirrhosis is when your liver has developed scars (cirrhosis) because of fatty liver disease called NASH or MASH. It's a serious condition that can worsen over time.

What does 'compensated cirrhosis' mean?

Compensated means your liver, despite being scarred, is still managing to do its job well enough, and you haven't yet developed severe symptoms or complications from it.

What is efruxifermin?

Efruxifermin is a new medicine being tested to see if it can help improve liver health in people with NASH/MASH cirrhosis.

What is a placebo?

A placebo is a dummy medicine that looks exactly like the study medicine but doesn't contain any active drug. It's used to compare results and ensure the real medicine's effects are clear.

Can I choose whether I get the new medicine or the placebo?

No, you would be randomly assigned to receive either the new medicine or the placebo. Neither you nor your doctor will know which you are receiving during the study.

How to find out more

Akero Study Director

akerosynchrony@akerotx.com 650-487-6488 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.