RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH

This research study is looking into a new medication called Pegozafermin for individuals diagnosed with a liver condition known as MASH, specifically when it has led to cirrhosis. MASH is a type of fatty liver disease that can cause scarring. The main goal is to see if Pegozafermin can help improve the liver condition and if it is safe to use. Some people in the study will receive the new medicine, while others will receive a placebo, which looks like the medicine but contains no active ingredients. This helps researchers understand the real effects of Pegozafermin. The study is currently in its third phase of testing.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

89bio, Inc.

Enrolment target

762

Start

24 May 2024

Estimated completion

01 Aug 2031

Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

What is this study about?

This study is a research project designed to explore a new potential treatment called Pegozafermin. It's for people who have a liver condition known as MASH, which stands for Metabolic Dysfunction-Associated Steatohepatitis. You might have heard of it before as NASH (Nonalcoholic Steatohepatitis). With MASH, you have fat in your liver, along with swelling and damage, which can lead to scarring.

In this particular study, they are focusing on people whose MASH has progressed to a stage called 'compensated cirrhosis.' This means there's significant scarring in the liver (cirrhosis), but your liver is still working well enough to carry out its important jobs. The researchers want to find out if Pegozafermin can help improve this condition and prevent it from getting worse.

To do this, some people will receive the new medicine, Pegozafermin, while others will receive a 'placebo.' A placebo looks exactly like the actual medicine but doesn't contain any active ingredients. This is a common way to test new medicines, as it helps researchers understand if any changes are truly due to the new drug or other factors. The study will carefully monitor the health of all participants to assess how effective and safe Pegozafermin is.

Key takeaways

This study is testing a new medicine for MASH with compensated cirrhosis.
It aims to see how well Pegozafermin works and if it's safe.
Some participants will receive the new drug, others a placebo.
The study is in advanced stages of testing (Phase 3).
Close medical supervision is provided during the study.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would need to be an adult between the ages of 18 and 75. You must have a confirmed diagnosis of MASH with compensated cirrhosis, meaning your liver has significant scarring but is still working.

Additionally, you should have type 2 diabetes or at least two other risk factors for metabolic problems. Your Body Mass Index (BMI) also needs to be within a specific range, generally between 25 and 50, though it's a bit lower for people of Asian descent.

There are also reasons you might not be able to join. For instance, if you have a different type of liver disease, if your liver disease has caused severe problems (decompensation), or if you have or have had liver cancer. People with type 1 diabetes or poorly controlled type 2 diabetes, or very high liver enzyme levels, would also not be able to take part.

Quick self-check

Are you between 18 and 75 years old?
Do you have a diagnosis of MASH with compensated cirrhosis?
Do you have type 2 diabetes or at least two other metabolic risk factors?
Is your Body Mass Index (BMI) generally between 25 and 50 (or 23-50 if you're of Asian descent)?
Do you *not* have other types of liver disease?
Have you *not* experienced severe liver problems or liver cancer?

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

What does participation involve?

The details of what taking part involves aren't fully described here, but typically, joining a clinical study like this means you would have regular visits to the clinic. These visits usually include blood tests, physical examinations, and possibly other tests like scans or repeat liver biopsies to check on your liver health. You would be given either the study medicine (Pegozafermin) or a placebo to take as instructed.

Researchers would closely monitor your health throughout the study to track how the medicine is affecting you and to check for any side effects. There would be a follow-up period after you stop taking the medicine to ensure your well-being. The total duration of your participation, including treatment and follow-up, would be made clear to you before you agree to join.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as gaining access to a new treatment for your MASH that isn't yet available. You'll also receive close medical attention and monitoring from a team of healthcare professionals. However, there are potential risks, including side effects from the study medication, which may or may not be known yet. There's also a chance you might receive the placebo and not the active drug. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (303)

89bio Clinical Study Site
Birmingham, United States· Recruiting
89bio Clinical Study Site
Homewood, United States· Recruiting
89bio Clinical Study Site
Chandler, United States· Recruiting
89bio Clinical Study Site
Flagstaff, United States· Withdrawn
89bio Clinical Study Site
Peoria, United States· Recruiting
89bio Clinical Study Site
Phoenix, United States· Recruiting
89bio Clinical Study Site
Tucson, United States· Recruiting
89bio Clinical Study Site
Tucson, United States· Recruiting
89bio Clinical Study Site
Tucson, United States· Recruiting
89bio Clinical Study Site
Little Rock, United States· Recruiting
89bio Clinical Study Site
North Little Rock, United States· Recruiting
89bio Clinical Study Site
Camarillo, United States· Recruiting

+291 more sites — see the official record for the full list.

Common questions

What is MASH?

MASH stands for Metabolic Dysfunction-Associated Steatohepatitis. It's a serious liver disease where you have fat in your liver along with swelling and damage, which can lead to scarring.

What does 'compensated cirrhosis' mean?

Compensated cirrhosis means your liver has significant scarring, but it's still able to work well enough to do most of its jobs without causing major problems yet.

What is a placebo?

A placebo is a dummy medicine that looks just like the real medicine but contains no active drug. It's used in studies to compare against the new medicine's effects.

Why do some people get a placebo?

Giving some people a placebo helps researchers figure out if the changes they see are truly because of the new medicine or if they would have happened anyway.

Can I stop participating in the study if I change my mind?

Yes, you have the right to withdraw from the study at any time, for any reason, without it 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.