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AOD9604: Discovery and Regulatory History A chronological reference on AOD9604, tracing a single scientific question at Monash University about the growth-hormone C-terminus into a stabilized hexadecapeptide, six controlled human trials, the OPTIONS endpoint outcome, a US FDA GRAS pivot, and its status under anti-doping regulation
lowest tolerated dose Phase Step 2 Weeks Weeks 5-8 Cagrilintide Dose 0.5 mg/week Purpose Dose escalation Phase Step 3 Weeks Weeks 9-12 Cagrilintide Dose 1.0 mg/week Purpose GI side effects often peak here Phase Step 4 Weeks Weeks 13-16 Cagrilintide Dose 1.7 mg/week Purpose Approaching maintenance Phase Maintenance Weeks Weeks 17+ Cagrilintide Dose 2.4 mg/week Purpose Target dose used in late-stage study protocols Each step lasts 4 weeks
