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What FDA Requires for NASH Approval FDA NASH Drug Approval Criteria (Based on Past Trials): Option 1: Histological Improvement (Biopsy-Based) NASH resolution (no inflammation, no ballooning) AND no worsening of fibrosis OR Fibrosis improvement (1 stage reduction) AND no worsening of NASH Option 2: Surrogate Endpoints (If Validated) Combination of imaging + biomarkers Must correlate with clinical outcomes Requires extensive validation Retatrutide's Current Status: Phase 2a: Fat reduction proven (surrogate endpoint) Phase 3 (TRIUMPH): Liver enzymes being measured (secondary) Still needs: Dedicated NASH trial with liver biopsies Phase 3 TRIUMPH: What Liver Data Will We Get

A structured metabolic evaluation can help identify whether the GLP-1 response needs medical support

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In the human body, the PLG polymers slowly degrade through the non-catalyzed hydrolysis of the ester linkages into lactic acid and glycolic acid, which are finally eliminated as carbon dioxide and water

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Optum Rx has introduced a host of tools at the formulary and benefit design levels, to ensure GLP-1 drugs are used responsibly