Accuracy of Ultrasound Biomarkers for Assessing Eligibility and Response to Resmetirom Therapy Using MRI as the Reference Standard

Summary

This is a prospective, non-interventional, observational study to evaluate the accuracy of 2 US (ultrasound) biomarkers that quantify liver tissue fat and stiffness: UDFF (ultrasound-derived fat fraction) and pSWE (point shear wave elastography) for determining MRI-defined eligibility for resmetirom (REZDIFFRA®) treatment and for monitoring treatment response using MRI-PDFF (proton density fat fraction) and MRE (magnetic resonance elastography) as reference standards. Study Centers Planned: 3 clinical practice facilities in Houston TX . Study Rationale: MASLD (metabolic dysfunction-associated steatotic liver disease ) is a growing global epidemic and the most common liver disease worldwide. Approximately 25% of adults in the United States alone have hepatic steatosis in the absence of significant alcohol consumption and 1 in 4 of these adults are presumed to have MASH. MASH has a higher likelihood of progression to irreversible liver damage including cirrhosis and hepatocellular carcinoma. Despite advancements in the field, there is still a high unmet need for technologies to accurately and reliably grade liver steatosis and stage liver fibrosis for applications related to patient identification and monitoring response to therapeutic intervention. The association between hepatic steatosis and fibrosis progression underscores the need to have accurate and reliable noninvasive tools to aid in the assessment and monitoring of both liver steatosis and fibrosis. The combination of 2 US (ultrasound) biomarkers that quantify liver tissue fat and stiffness (UDFF and pSWE) may aid clinicians in streamlining patient care pathways and potentially avoid unwanted and invasive medical intervention.

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