Active not recruitingPHASE3INTERVENTIONAL

A Study Evaluating Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

This research is looking into a new medicine called Efruxifermin for liver conditions known as NAFLD/MASLD (fatty liver disease) and NASH/MASH (a more serious type of fatty liver disease). The main goal is to check how safe this medicine is and if people can tolerate it well when compared to a placebo, which is a dummy medicine containing no active drug. This is a Phase 3 study, meaning it’s a big, later-stage trial to confirm the medicine's effects. We’re inviting adults aged 18 to 80 who have been diagnosed with these liver conditions, often linked to other health issues like obesity or diabetes, to take part. The study aims to help us understand if Efruxifermin could be a future treatment option.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Akero Therapeutics, Inc

Enrolment target

700

Start

10 Nov 2023

Estimated completion

19 Jun 2026

NASH/MASH NAFLD/MASLD

What is this study about?

This study is about a new medicine called Efruxifermin, and it's being tested for people who have certain liver conditions. These conditions are often called NAFLD/MASLD, which stands for non-alcoholic fatty liver disease, and NASH/MASH, which is a more advanced type of fatty liver disease. Essentially, these conditions mean there's too much fat in the liver, which can sometimes lead to inflammation and damage. The 'non-alcoholic' part means it's not caused by drinking too much alcohol.

The main purpose of this study is to see how safe Efruxifermin is and if people can take it without too many problems. We're also comparing it to a 'placebo', which looks exactly like the study medicine but doesn't contain any active drug. This helps us understand if any changes are truly due to the new medicine or if they might happen anyway. This type of study is called a Phase 3 trial, which means it's a large and important step in checking if a new medicine could eventually be made available to everyone.

By taking part, you could help doctors learn more about these liver conditions and whether Efruxifermin could be a helpful treatment in the future. We're looking for individuals who have been diagnosed with NAFLD/MASLD or NASH/MASH, often alongside other health issues like being overweight, having high blood pressure, or diabetes. Your involvement could make a real difference in advancing medical knowledge and helping others with similar conditions.

Key takeaways

The study is for adults with fatty liver conditions (NAFLD/MASLD or NASH/MASH).
It's testing a new medicine, Efruxifermin, against a dummy medicine (placebo).
The main aim is to check the medicine's safety and how well people tolerate it.
Participation involves regular clinic visits for health checks and tests.
Your involvement could help develop future treatments for liver disease.

Who may be eligible?

To be part of this study, you need to be an adult between 18 and 80 years old. You should also have either NAFLD/MASLD or NASH/MASH, which are liver conditions. Often, people with these liver conditions also have other health issues like being overweight, having high blood pressure, or diabetes. If you've been in a previous Akero study, there's a special option for you to join an extended part of this trial.

There are also some reasons why you might not be able to join. For example, if your liver problems are caused by something else, like drinking too much alcohol, other long-term illnesses, or certain medications. Also, if you have Type 1 diabetes, or your Type 2 diabetes isn't well-controlled, you might not be suitable for this study.

The research team will carry out checks to make sure this study is right for you and safe for you to take part. They will explain everything clearly, and you'll have the chance to ask any questions you have.

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 told you have NAFLD/MASLD or NASH/MASH?
Do you have health conditions like obesity, high blood pressure, or Type 2 diabetes?
Do you have any other liver conditions that aren't NAFLD/MASLD or NASH/MASH?
Do you have Type 1 diabetes, or poorly controlled Type 2 diabetes?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the new medicine, Efruxifermin, or a placebo (a dummy medicine) throughout the study. Neither you nor your study doctor will know which one you're receiving. You'll need to attend clinic visits regularly for health checks, blood tests, and other assessments to monitor your health and how the medicine is affecting you. The total duration of your involvement in the study, including all visits and follow-up, will be fully explained by the research team.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving a new investigational treatment or being closely monitored by medical professionals. However, there are also potential risks, as the new medicine could cause side effects, some of which might not be known yet. The research team will discuss all known risks and benefits with you in detail. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (211)

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
Akero Clinical Study Site
Verified postcode
Chandler, United States
Akero Clinical Study Site
Verified postcode
Flagstaff, United States
Akero Clinical Study Site
Verified postcode
Peoria, United States
Akero Clinical Study Site
Verified postcode
Tucson, United States
Akero Clinical Study Site
Verified postcode
Tucson, United States
Akero Clinical Study Site
Verified postcode
Conway, United States
Akero Clinical Study Site
Verified postcode
Jonesboro, United States
Akero Clinical Study Site
Verified postcode
Little Rock, United States
Akero Clinical Study Site
Verified postcode
North Little Rock, United States
Akero Clinical Study Site
Verified postcode
Chula Vista, United States
Akero Clinical Study Site
Verified postcode
Coronado, United States

Common questions

What are NAFLD/MASLD and NASH/MASH?

These are liver conditions where too much fat builds up in the liver. NASH/MASH is a more serious type where the liver also becomes inflamed and damaged.

What is a placebo?

A placebo is a dummy medicine that looks exactly like the study drug but doesn't contain any active ingredients. It helps researchers see if the real medicine is actually working.

Will I know if I'm getting the real medicine or the placebo?

No, during the main part of the study, neither you nor your study doctor will know whether you are receiving Efruxifermin or the placebo. This helps make the study results fair.

Is this medicine available for everyone yet?

No, Efruxifermin is an 'investigational' medicine, which means it's still being studied and is not yet approved or available for general use outside of clinical trials.

What if I change my mind about taking part?

You are free to leave the study at any time, for any reason, without it affecting your usual medical care.