Rezdiffra™ (resmetirom) and NASH: A Promising Advance in Treatment

March 14, 2024 | By Michelle Jones | News & Events, Clinical Trials, Liver, Liver Disease, Liver Health, NASH | Promising Advance in Treatment, resmetirom, Rezdiffra

Nonalcoholic Steatohepatitis (NASH) (now known as Metabolic Dysfunction-Associated Steatohepatitis or MASH) represents a significant and growing challenge in clinical practice, with its progression to cirrhosis and hepatocellular carcinoma posing serious risks for patients. The exciting new conditional commercial launch of Rezdiffra, an oral thyroid hormone receptor beta–selective agonist, offers compelling evidence for its use in treating NASH with liver fibrosis.   Let’s delve into the Phase 3 study’s findings and implications for patient care that led to this groundbreaking new drug therapy.  

Study Overview 

The phase 3 MAESTRO-NASH randomized, controlled trial involved over adults with biopsy-confirmed NASH and fibrosis stages F1B to F3. Participants received either Rezdiffra (80 mg or 100 mg) or a placebo daily. The primary endpoints were NASH resolution without worsening of fibrosis and a reduction in fibrosis by at least one stage without worsening of the NAFLD activity score. 

Key Findings 

• NASH resolution without fibrosis worsening was significantly higher in both Rezdiffra groups compared to the placebo. 
• Improvement in liver fibrosis by at least one stage was significantly more frequent among Rezdiffra recipients. 
• Rezdiffra groups experienced notable reductions in LDL cholesterol levels. 

• Side effects included diarrhea and nausea, but the incidence of serious adverse events was similar across all groups. 

 Clinical Implications 

Rezdiffra has shown considerable promise in addressing the dual challenges of NASH resolution and fibrosis improvement. Its impact on LDL cholesterol also underscores its potential in managing cardiovascular risk factors associated with NASH. While the occurrence of gastrointestinal side effects warrants consideration, the overall tolerability and safety profile of Resmetirom is encouraging. 

As we integrate these findings into clinical practice, it’s crucial to consider Resmetirom as part of a comprehensive management plan for patients with NASH. Ongoing dialogue with patients about the benefits and potential side effects of Resmetirom will be key in optimizing outcomes. 

The availability of the first NASH drug, Resmetirom, marks a significant advancement in the treatment landscape for NASH, offering hope for improved liver health and overall outcomes.  

Contact us today to refer your liver patents to our office – we strive to stay in close communication with our referring providers so that you are always aware of our recommendations as well as the progress of your patients.