Studied in registered human trials with published pharmacokinetic data, but not approved. Dosing outside a trial protocol has no established safety margin.
No published human pharmacokinetic half-life exists, despite AOD-9604 having progressed to Phase 2b. Commonly cited figures could not be traced to a retrievable source.
Doses studied in a 12-week randomised trial in obese subjects: 1 mg/day and 10 mg/day. The dose-response was NOT monotonic, the 1 mg group lost 2.6 kg vs 0.8 kg for placebo, while the 10 mg group showed a SMALLER reduction. These are failed-trial doses, not validated therapeutic doses.
The effective dose did NOT elevate plasma IGF-1, its lipid effect is mechanistically distinct from IGF-1 secretion, a genuine and useful distinction from GH. However, the compound FAILED to show commercially meaningful efficacy in Phase 2b: weight loss was modest (2.6 kg over 12 weeks) and not dose-dependent. Marketing that presents AOD-9604 as an effective fat-loss agent is not supported by its own trial data. Long-term safety is not characterised.