Phase III MAESTRO-NAFLD-1 study of MGL 3196 shows it to be safe and well-tolerated in non-alcoholic fatty liver disease.
The 52-week study demonstrated that resmetirom was safe and well-tolerated at 80 and 100 mg once a day dosing. Additionally, resmetirom helped patients with presumed non-alcoholic steatohepatitis (NASH) achieve significant, clinically relevant reductions in liver fat and atherogenic lipids.
Hierarchically-controlled key secondary endpoints were achieved for both the 80 and 100 mg resmetirom dose groups. Resmetirom provided significant reductions in liver fat as measured by MRI-PDFF and reduced atherogenic lipids, including LDLc, apolipoprotein B and triglycerides. Although both arms were randomized in MAESTRO-NAFLD-1, lipid reductions were numerically greater in the 100 mg open label treatment arm compared to the 100 mg double-blind arm. Patients in the open-label active 100 mg treatment arm were less impacted by COVID-related dose interruptions than double-blind patients.
Resmetirom was safe and well-tolerated at the 80 mg dose and also importantly at the top dose of 100 mg in MAESTRO-NAFLD-1. Adverse events observed in the MAESTRO-NAFLD-1 trial were generally mild to moderate in severity. The frequency of serious adverse events was similar across treatment arms and discontinuation for adverse events was low.
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