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
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Lifestyle changes and over-the-counter medications like antacids, H2 blockers, and PPIs can help manage Ozempic-related heartburn
Safe injection technique is essential to ensure the medication is delivered correctly, minimise discomfort, and reduce the risk of complications such as infection or poor drug absorption
People with complex medical histories, pregnancy or breastfeeding considerations, diabetes medications, gastrointestinal disease, kidney disease, pancreatitis history, gallbladder concerns, or possible drug interactions should discuss risks with a licensed clinician