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Resmetirom In Line to Become First Medication-Based Treatment for MASH

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Christina DeBusk

Feb 19th, 2024

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Up to today, this particular liver disease could not be treated by medication as none were available. Madrigal Pharmaceuticals hopes to change this with what may become the first medication approved for MASH* treatment: resmetirom.

*MASH is short for metabolic dysfunction-associated steatohepatitis. Previously referred to as non-alcohol related steatohepatitis or NASH, this condition involves liver inflammation due to excessive fat cells. While MASH is the new term, we use NASH in this article when referring to research and other documentation to stay true to those forms.

What Is Resmetirom and How Might It Help Treat MASH?

On September 13, 2023, Madrigal announced that the U.S. Food and Drug Administration (FDA) had accepted its application for resmetirom, a drug created to treat adult patients who have NASH with liver fibrosis. (1) Additionally, the FDA granted Priority Review of the drug, which fast-tracks its consideration.

Resmetirom is an oral medication taken once daily. It is in a class of medicines known as thyroid hormone receptor (THR)-β selective agonists. Research suggests that THR-β selective agonists can help lower cholesterol and triglyceride levels. (2) As such, they may help treat conditions involving liver inflammation by targeting underlying factors associated with these diseases.

Madrigal supplied the FDA with 18 clinical studies supporting the use of resmetirom for NASH with liver fibrosis. Twelve were Phase 1 studies, two were Phase 2 studies, and four were Phase 3 studies.

• Phase 1 studies are used to determine if the treatment is safe and the best way to give it (such as orally or intravenously).
• Phase 2 studies focus on whether the treatment is effective and if it could lead to any side effects.
• Phase 3 studies compare the new treatment to any existing treatments to see if it offers better results. (3)

Resmetirom Could Change the Landscape of MASH Treatment Options

If resmetirom is approved for MASH treatment, it would be the first pharmaceutical medication available for this purpose. Currently, individuals diagnosed with MASH are generally advised to make lifestyle modifications such as: (4)

• Eating a healthy, balanced diet
• Getting regular physical exercise
• Keeping their blood sugar stable (especially for individuals with diabetes)

While these are still good pieces of advice, having a medication option may further reduce the progression of metabolic dysfunction-associated steatohepatitis. It would also provide another treatment for people who may not be seeing the results they’d like with lifestyle changes alone.

MASH and MASLD: New Names for Long-Known Liver Diseases

If you’re confused by NASH now being MASH, you aren’t alone.

Why has this changed?

At the EASL Congress 2023, a group of leaders in hepatology—which includes those from the American Association for the Study of Liver Diseases (AASLD)—announced that NASH would now be called MASH and NAFLD (nonalcoholic fatty liver disease) is to be replaced with MASLD (metabolic dysfunction-associated steatotic liver disease). (5)

One reason for this change of names was that the new names are more affirmative and less stigmatizing. Hepatic professionals also want the names to include reference to the metabolic risk factors that are often present with these liver diseases, with ‘metabolic dysfunction’ being the chosen phrase of choice. In this way, the new names are more reflective of these liver conditions.

The Future of MASH Treatment

Regardless of whether you use the new MASH term or stick with the prior use of NASH, FDA acceptance of the New Drug Application for resmetirom holds promise for individuals with this condition. It’s a reminder that many people are working feverishly in an attempt to get patients help beyond simply suggesting lifestyle changes.

It may be a while before final approval could be received for resmetiron, or any other drug designed to treat MASH, so continue making positive lifestyle habits and following your healthcare provider’s advice.

We’ll keep you updated if any advances are made.

About the Author

Christina DeBusk

Christina M. DeBusk is a health writer and editor who specializes in natural wellness, disease prevention and treatment options. She is also a Certified Nutrition Specialist, Personal Trainer, and Transformation Specialist. You can find her articles in a variety of health-related publications, both online and in print.