Active not recruitingPHASE3INTERVENTIONAL

A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis

This study is investigating a new medication called MGL-3196 (also known as Resmetirom) for individuals diagnosed with Nonalcoholic Steatohepatitis, or NASH, a type of liver disease accompanied by scarring (fibrosis). The main goal is to find out if this new drug can help resolve NASH and reduce the liver scarring, or even prevent it from progressing to more severe liver problems like cirrhosis. Participants will receive either the active medicine or a dummy pill (placebo) in a random, blinded way, meaning neither they nor their doctors will know which they are taking. We will be checking liver health over time, including through liver biopsies.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Madrigal Pharmaceuticals, Inc.

Enrolment target

1,759

Start

28 Mar 2019

Estimated completion

01 Jan 2028

NASH - Nonalcoholic Steatohepatitis

What is this study about?

This research study is focused on a liver condition called Nonalcoholic Steatohepatitis, or NASH. It's a serious form of fatty liver disease where there's not only fat in the liver but also inflammation and liver cell damage, which can lead to scarring, known as fibrosis. Over time, this scarring can get worse and lead to more serious liver problems like cirrhosis or even liver failure.

The study is testing a new medicine called MGL-3196 (also known as Resmetirom). The main aim is to see if this medicine can help improve the liver's condition by reducing the inflammation and scarring, and potentially stopping the disease from getting more severe. We want to understand how effective and safe this new treatment is for people living with NASH and liver scarring.

To do this, some people will receive the new medicine, while others will receive a dummy pill (placebo). This is a common way to test new drugs reliably, as it helps us understand if any improvements are truly due to the medicine or other factors. Both you and your study doctor won't know which one you're taking. We'll be carefully monitoring participants through various tests, including liver biopsies, to check for changes in their liver health over about a year.

Key takeaways

This study is testing a new medicine for NASH and liver scarring.
It aims to see if the medicine improves liver health and stops disease progression.
Participants will receive either the active medicine or a dummy pill.
The study involves regular clinic visits, blood tests, scans, and liver biopsies.
Participation lasts for about one year, with follow-up after.
Your medical care will not be affected if you choose to leave the study.

Who may be eligible?

To join this study, you need to be an adult aged 18 or over. You should have a suspected or confirmed diagnosis of NASH with some degree of liver scarring (fibrosis), which we generally confirm through a liver biopsy done recently or a few years ago if your weight hasn't changed much. We also look at special scans like FibroScan and MRI to measure liver fat and stiffness.

There are also some reasons why you might not be able to join. For example, if you've consumed a lot of alcohol recently, used certain medications that affect your liver, or have specific thyroid problems that aren't well controlled. If you've had major weight-loss surgery in the last five years or are planning to have one, you wouldn't be able to participate. We're also looking for people whose weight has been relatively stable, as significant recent weight changes can affect liver health and study results.

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 18 years old or older?
Do you have a diagnosis of NASH with liver scarring?
Have you had stable weight recently (no large changes)?
Have you avoided heavy alcohol consumption in the last year?
Have you not had weight-loss surgery in the last 5 years?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance to either receive the study medicine (MGL-3196) or a dummy pill (placebo). You'll take this medicine daily. You'll have several visits to the clinic over about a year for various assessments. These will include blood tests, special scans of your liver, and physical examinations. A key part of the study involves liver biopsies, which are small tissue samples taken from your liver, at the beginning of the study and again after about a year (at Week 52). These biopsies help us see how the medicine might be affecting your liver scarring. You'll also have follow-up appointments after your main treatment period to ensure your safety and monitor your health.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. The potential benefit is that the study medicine, MGL-3196, might improve your NASH and liver scarring, although there's no guarantee, especially if you receive the placebo. Potential risks include side effects from the study medicine, discomfort or complications from procedures like liver biopsies, and the time commitment required for clinic visits and tests. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (247)

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

University of Alabama at Birmingham
Verified postcode
Birmingham, United States
East Valley Family Physicians
Verified postcode
Chandler, United States
The Institute for Liver Health - Chandler
Verified postcode
Chandler, United States
The Institute for Liver Health - Glendale
Verified postcode
Glendale, United States
Desert Clinical Research
Verified postcode
Mesa, United States
Adobe Gastroenterology
Verified postcode
Tucson, United States
The Institute for Liver Health - Tucson
Verified postcode
Tucson, United States
Arkansas Gastroenterology
Verified postcode
North Little Rock, United States
Fresno Clinical Research Center
Verified postcode
Fresno, United States
National Research Institute - Huntington Park
Verified postcode
Huntington Park, United States
University of California San Diego
Verified postcode
La Jolla, United States
Cedars-Sinai Medical Center
Verified postcode
Los Angeles, United States

Common questions

What is NASH?

NASH (Nonalcoholic Steatohepatitis) is a liver disease where you have fat in your liver, along with inflammation and damage to liver cells, which can lead to scarring.

What is a placebo?

A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers understand if the real medicine is truly effective.

What is a liver biopsy?

A liver biopsy is a procedure where a very small piece of your liver is taken out with a needle. It helps doctors look closely at your liver tissue under a microscope to check for damage and scarring.

How long will I be in the study?

You will be in the main part of the study for about 52 weeks (roughly one year), which includes taking the study medicine and having assessments. There might be some follow-up appointments afterwards.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time and for any reason. Your decision will not affect your future medical care.