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A key differentiator of Mardrigals resmetirom is that in a pivotal Phase 3 trial, it achieved both primary endpoints of NASH resolution and reduction in fibrosis (MAESTRO-NASH), the two liver histological improvement endpoints the FDA has proposed as reasonably likely to predict clinical benefit

This was despite some concerns outlined in briefing documents regarding Lillys trial methodology, including its use of the integrated Alzheimers Disease Rating Scale (iADRS) as the primary endpoint, the use of tau protein levels to decide study inclusion and the cessation of donanemab treatment in patients whose brain amyloid levels dropped past a certain, pre-specified threshold

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Controlled drug delivery systems: current status and future directions