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Side Effects & Safety AOD-9604 has a favorable safety profile supported by clinical trial data: FDA GRAS status: The compound received GRAS status as a food ingredient, reflecting some regulatory safety evaluation, though this is not equivalent to drug safety approval Clinical trial tolerability: Phase I and Phase II clinical trials conducted by Metabolic Pharmaceuticals generally found AOD-9604 well-tolerated at studied doses Injection site reactions: Minor discomfort with subcutaneous administration Headache and nausea: Reported in some clinical trial subjects No significant metabolic effects: Blood glucose, insulin, HbA1c, and IGF-1 were not significantly altered in clinical studies, which distinguishes it favorably from full GH Long-term safety data for subcutaneous use in the research community context (typically higher and more frequent dosing than clinical trials) is limited

Functional inactivation of the IGF-I and insulin receptors in skeletal muscle causes type 2 diabetes

Journal of Nuclear Medicine 30, 1989

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