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EMA Decision P/0336/2024 Paediatric Investigation Plan for Retatrutide

32 The relationship between GH, cortisol and insulin is key to the regulation of body growth, and bone, fat, protein and carbohydrate metabolism, confirming GH as a metabolic hormone as much as a growth hormone

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If improvements in sleep quality and deep sleep markers (selfreported) show up and theres no adverse effect, they may continue at that dose for 24 weeks before considering any increase (e.g., to 250 mcg)

Current approaches include: Continuous Use Approach: Based on clinical trials that used continuous daily administration for 12-24 weeks without scheduled breaks