Resmetirom + Nutrition for Non-Alcoholic Fatty Liver Disease

(NOURISH-MASH Trial)

This trial tests whether combining resmetirom, a medication for liver disease, with a Mediterranean diet improves liver health more effectively than the medication alone. It targets individuals with non-alcoholic fatty liver disease, a liver condition not caused by alcohol, that has not progressed to cirrhosis. Participants will either receive meals tailored to the Mediterranean diet along with online lifestyle education or just standard diet advice and telehealth support. Ideal participants have been diagnosed with this specific liver condition and plan to start resmetirom treatment. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment benefits a broader range of patients.

Research has shown that resmetirom is generally safe for people. Studies have found it to be well tolerated at daily doses of 80 mg and 100 mg. In one study, most participants experienced some side effects, but these were not serious. The side effects were similar for both 80 mg and 100 mg doses.

Unlike the standard treatments for Non-Alcoholic Fatty Liver Disease, which often focus on lifestyle changes and medications that target symptoms, Resmetirom is unique in its approach. Resmetirom specifically targets thyroid hormone receptors in the liver, aiming to reduce liver fat more directly. Researchers are excited about Resmetirom because it has the potential to significantly improve liver health by addressing the underlying cause of fat accumulation, rather than just managing symptoms. Additionally, the trial combines this medication with a comprehensive lifestyle program, potentially offering a more holistic and effective approach to treatment.

Research has shown that resmetirom effectively treats metabolic dysfunction-associated steatohepatitis (MASH). Studies have demonstrated that it can reduce liver fat by over 30%, improving another liver condition known as NASH. In one study, patients treated with resmetirom experienced a 36.3% reduction in liver fat. Additionally, resmetirom has been linked to significant weight loss and improved liver health indicators. Participants in this trial will receive resmetirom as part of different treatment arms. One arm combines resmetirom with medically tailored meals and lifestyle education, while another includes resmetirom with standard-of-care lifestyle education. The FDA has approved resmetirom for treating liver problems caused by fat buildup, confirming its effectiveness for at least one condition.¹²⁴⁶⁷