That's not for NASH that's for NAFLD. That phase 3
Post# of 153933
(Total Views: 746)
Posted On: 01/31/2022 8:49:35 AM
That's not for NASH that's for NAFLD. That phase 3 trial was primarily to find dosage and safety. None of the endpoints are for fibrosis and no mention in the results. They are going to do a new phase 3 trial for NAFLD.
Quote:
Primary Endpoint 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 (Table 1) and discontinuation for adverse events was low. Serious adverse events occurred at expected rates based on the patient population.
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
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