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They're designed to: Confirm the weight loss and metabolic benefits seen in Phase 2 Identify rare side effects that smaller trials might have missed Demonstrate consistent results across diverse populations (age, sex, ethnicity, comorbidities) Build long-term safety data (cardiovascular outcomes, liver health, kidney function) Provide the evidence package the FDA needs to approve the drug Retatrutide's Phase 2 results were strong enough (up to 24.2% weight loss) that Eli Lilly moved it into a large Phase 3 program

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Diabetologia 61 , 21082117 (2018)