RecruitingPHASE3INTERVENTIONAL

A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)

This research study, called ENLIGHTEN-Fibrosis, is testing a new medicine called pegozafermin. It's for adults who have a liver condition known as MASH, specifically when it involves scarring or "fibrosis" in the liver at stages F2 or F3. MASH used to be called NASH. The study aims to find out if pegozafermin is safe and effective in treating this condition compared to a 'placebo', which is a dummy medicine containing no active drug. We'll be looking at two different doses of pegozafermin. This is a Phase 3 study, meaning it’s a later stage of research and involves more people, helping us get a clearer picture of how well the medicine works and if it has any side effects.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

89bio, Inc.

Enrolment target

1,350

Start

13 Mar 2024

Estimated completion

01 Feb 2029

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

What is this study about?

This study is looking into a new medicine called pegozafermin for a common liver condition. This condition is now called Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH), but you might also know it as Nonalcoholic Steatohepatitis (NASH). It means there's too much fat in the liver, leading to inflammation and sometimes scarring, which doctors call fibrosis. Severe scarring can, over time, cause serious liver damage.

The main goal of this study is to see if pegozafermin can help improve MASH and reduce the liver scarring in people who have specific levels of scarring (stages F2 or F3). We want to understand if it's safe to use and how well it works compared to a 'placebo' medicine, which looks exactly like pegozafermin but contains no active drug. This helps us know if any changes are truly due to the new medicine.

Finding new and effective treatments for MASH with fibrosis is very important. Currently, there aren't many approved medicines specifically for this condition, and it affects many people. By taking part in this study, you could help researchers learn more and potentially contribute to developing a new treatment that could help many others in the future.

Key takeaways

This study is for adults with a liver condition called MASH and liver scarring (fibrosis F2 or F3).
It tests a new medicine, pegozafermin, against a dummy medicine (placebo).
The goal is to see if pegozafermin is safe and helps improve liver scarring.
Participation involves regular clinic visits for tests and to receive study medicine.
You have the right to withdraw from the study at any time.
Your involvement could help develop new treatments for MASH.

Who may be eligible?

To join this study, you need to be an adult between 18 and 80 years old. An important requirement is that you must have a confirmed diagnosis of MASH with liver scarring, specifically at stages F2 or F3, which would have been identified through a liver biopsy. Your body mass index (BMI) should also be 25 or higher, or 23 or higher if you are of Asian descent. This is a common health measure.

There are also reasons why you might not be able to join. For example, if you have other serious liver diseases apart from MASH, or if your liver biopsy shows your scarring has already progressed to cirrhosis, you wouldn't be able to take part. Also, if you have type 1 diabetes, or type 2 diabetes that isn't well controlled, or very high levels of certain liver enzymes (ALT or AST) in your blood, you might not be eligible. If you're taking particular supplements like high-dose vitamin E or a medicine called pioglitazone, you would need to have been on a steady dose for at least six months before starting the study.

These are just some of the main points, and there are other detailed rules that the study team will discuss with you to make sure the study is right for you and you meet all the criteria.

Quick self-check

Are you between 18 and 80 years old?
Have you been diagnosed with MASH and confirmed liver scarring (fibrosis) at stage F2 or F3?
Is your body mass index (BMI) 25 or higher (or 23 or higher if you are of Asian descent)?
Do you have any other chronic liver diseases besides MASH?
Have you been diagnosed with cirrhosis?
Are you on a stable dose of high-dose vitamin E or pioglitazone for at least 6 months, or not taking them at all?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you would receive either the new medicine, pegozafermin, or a placebo (a dummy medicine), which would be given to you regularly. You wouldn't know if you're getting the active medicine or the placebo. You would have regular appointments at the study clinic. These visits would involve various checks, such as blood tests, physical examinations, and possibly other tests to monitor your liver health and overall well-being. The study also involves follow-up appointments to see how you are doing over time. The total duration of your participation, including all treatments and follow-up, will be explained in full detail by the study team.

Potential risks and benefits

Taking part in a clinical study can have potential benefits, such as receiving close medical attention and access to a new experimental medicine that might help your condition. However, there are also potential risks, including side effects from the study medicine, even if it's a placebo, or discomfort from study procedures like blood tests. The study team will explain all known potential risks in detail. It’s important to remember that joining is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (349)

89bio Clinical Study Site
Birmingham, United States· Recruiting
89bio Clinical Study Site
Chandler, United States· Recruiting
89bio Clinical Study Site
Flagstaff, United States· Recruiting
89bio Clinical Study Site
Glendale, United States· Recruiting
89bio Clinical Study Site
Tucson, United States· Recruiting
89bio Clinical Study Site
Conway, United States· Terminated
89bio Clinical Study Site
Little Rock, United States· Recruiting
89bio Clinical Study Site
North Little Rock, United States· Recruiting
89bio Clinical Study Site
Canoga Park, United States· Recruiting
89bio Clinical Study Site
Coronado, United States· Recruiting
89bio Clinical Study Site
Escondido, United States· Recruiting
89bio Clinical Study Site
Fountain Valley, United States· Recruiting

+337 more sites — see the official record for the full list.

Common questions

What is MASH?

MASH stands for Metabolic Dysfunction-Associated Steatotic Liver Disease. It means there's fat in your liver, along with inflammation and cell damage, which can lead to scarring (fibrosis).

What is liver fibrosis F2 or F3?

Fibrosis refers to scarring in the liver. F2 and F3 describe the amount of scarring; F2 is moderate, and F3 is severe. This is usually determined by a liver biopsy.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real medicine but doesn't contain any active drug. It helps researchers fairly compare the new medicine's effects.

Will I know if I am getting the study medicine or the placebo?

No, in this type of study, neither you nor the study doctors will know whether you are receiving pegozafermin or the placebo. This helps ensure the results are unbiased.

Can I leave the study at any time?

Yes, your participation is completely voluntary. You can choose to leave the study at any point, for any reason, without affecting your regular medical care.

How to find out more

ENLIGHTEN clinical trial

enlighten@89bio.com 1-415-432-9270 Official trial record

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