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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

Remember, any movement forward, even slow, is still progress

May 22, 2025: 503B outsourcing facility enforcement discretion ends for semaglutide

Certain provider, state, or federal contract and/or mandate exceptions may apply

Starting at the lowest dose and gradually increasing it helps manage common gastrointestinal side effects like nausea or vomiting

Sources for Figure 2 18 Further reading This feature was based on evidence available at the time of writing