A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
This important study is testing a new medication, efruxifermin, for people diagnosed with a liver condition called NASH or MASH, where there's also some scarring in the liver (fibrosis F2 or F3). Researchers want to see if this medication is safe and effective in helping improve the liver. It's a 'Phase 3' study, meaning it's a key step before a medication might become widely available. Around 1,650 people will take part. Participants will either receive efruxifermin or a 'placebo' (a dummy treatment, like a sugar pill) without knowing which one they're getting. Doctors will carefully monitor liver health and general well-being over several years to understand the medication's full effects.
At a glance
What is this study about?
This study is focused on a liver condition called NASH or MASH (which stand for Nonalcoholic Steatohepatitis or Metabolic Dysfunction-Associated Steatohepatitis). In simple terms, this is when fat builds up in the liver, causing inflammation and damage, and potentially leading to scarring, also known as fibrosis. The study is particularly looking at people who have a moderate amount of scarring (rated as F2 or F3). The main goal is to see if a new medication called efruxifermin can help improve this liver condition and reduce the scarring.
This is a 'Phase 3' study, which is a major step in testing new medicines. It means researchers are trying to understand how well efruxifermin works and if it's safe for many people. To do this fairly, some participants will receive the active medication, while others will get a 'placebo' – a treatment that looks the same but contains no active drug. Neither the participants nor their doctors will know who is getting which treatment. This helps ensure the study results are as accurate as possible.
About 1,650 people will take part, divided into two groups. The study will closely monitor changes in their liver health using various tests, including liver biopsies, over several years. They'll also look at how participants generally feel, any side effects, and important health outcomes related to their liver. The hope is that efruxifermin could offer a new way to help people manage NASH/MASH and reduce the progression of liver scarring.
Key takeaways
- This study evaluates efruxifermin for NASH/MASH with liver scarring.
- It's a Phase 3 study, a key step in testing new medicines.
- Approximately 1,650 participants will be involved.
- Participants will receive efruxifermin or a placebo.
- The study assesses safety and effectiveness over several years.
- You'll receive regular medical checks and monitoring.
Who may be eligible?
To join this study, you need to be an adult between 18 and 80 years old. You also need to have a history or current presence of at least two out of four common health issues that are often linked to NASH/MASH, such as being overweight, having high cholesterol, high blood pressure, or type 2 diabetes.
Your liver condition needs to be confirmed by a recent liver biopsy showing NASH/MASH with moderate scarring (stage F2 or F3). If you are in one group (Cohort 1), your biopsy needs to show certain levels of fat, inflammation, and ballooning in your liver cells. If you're in the other group (Cohort 2), your biopsy needs to show F3 scarring, but the specific levels of fat and inflammation are less strict.
However, you won't be able to join if you have other types of liver disease that aren't NASH/MASH, or if your liver has already progressed to severe scarring (cirrhosis, or F4). Also, if you have uncontrolled type 2 diabetes or type 1 diabetes, you generally won't be able to participate. The study team will review all your health information carefully to make sure the study is right 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?
- Have you been diagnosed with NASH/MASH and moderate liver scarring (F2 or F3)?
- Do you have a history of conditions like obesity, high cholesterol, high blood pressure, or type 2 diabetes?
- Do you *not* have severe liver scarring (cirrhosis/F4) or other types of liver disease?
- Is your type 2 diabetes well-managed, or do you not have type 1 diabetes?
What does participation involve?
If you join this study, your journey will begin with a screening period that could last up to 12 weeks to ensure you meet all the requirements. Once confirmed, you'll be assigned by chance to one of three groups: receiving either a lower dose of efruxifermin, a higher dose of efruxifermin, or a placebo (a dummy treatment). You'll receive this medication as a weekly injection just under your skin.
You'll have regular visits to the clinic, especially during the first 52 weeks, where doctors will check your liver and overall health. Some participants will have a liver biopsy after 52 weeks, and others after 96 weeks. The total length of treatment and careful monitoring in the study could last up to about 240 weeks, which is roughly 4.5 years. There will also be a final check-up about a month after your last dose of the study medication to see how you are doing.
Potential risks and benefits
Locations (356)
- Akero Clinical Study SiteVerified postcodeBirmingham, United States· Recruiting
- Akero Clinical Study SiteVerified postcodeDothan, United States· Recruiting
- Akero Clinical Study SiteVerified postcodeChandler, United States· Recruiting
- Akero Clinical Study SiteVerified postcodeFlagstaff, United States· Completed
- Akero Clinical Study SiteVerified postcodePeoria, United States· Recruiting
- Akero Clinical Study SiteVerified postcodeTucson, United States· Recruiting
- Akero Clinical Study SiteVerified postcodeTucson, United States· Recruiting
- Akero Clinical Study SiteVerified postcodeTucson, United States· Recruiting
- Akero Clinical Study SiteVerified postcodeTucson, United States· Recruiting
- Akero Clinical Study SiteVerified postcodeConway, United States· Completed
- Akero Clinical Study SiteVerified postcodeJonesboro, United States· Completed
- Akero Clinical Study SiteVerified postcodeLittle Rock, United States· Recruiting
Common questions
What is NASH/MASH?
NASH/MASH is a liver condition where fat builds up in the liver, causing inflammation and damage, which can lead to scarring (fibrosis).
What is fibrosis?
Fibrosis is the medical term for scarring. In the liver, it means the liver tissue is becoming damaged and replaced by scar tissue.
What is a 'placebo'?
A placebo is a dummy treatment that looks just like the real medication but doesn't contain any active drug. It helps researchers fairly compare the new medicine's effects.
How will I receive the study medication?
The study medication, or placebo, will be given as an injection under the skin once a week.
How long will the study last for me?
You could be in the study for up to about 4.5 years, including treatment and follow-up visits.
How to find out more
Akero Study Director
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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