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The FDA identifies significant risks including lack of human safety data, potential for adverse immune reactions, and insufficient evidence regarding long-term effects, with the agency authorized to take enforcement action against compounding pharmacies that produce these substances for clinical applications

Phase 3 trial data documented 28.7% average weight loss with retatrutide 12mg versus 14.9% with semaglutide 2.4mg, though these come from different trials with different populations