AOD-9604: Safety Profile & Research Summary

Animal Studies

• In ob/ob mice, 500 µg/kg/day i.p. for 14 days produced ~5.5% body weight reduction (p < 0.05 vs. control) with a 50–60% increase in fat oxidation. No changes in blood glucose, insulin, or IGF-1 [1][2].
• In Zucker (fa/fa) rats, oral administration at 200–600 µg/kg/day for 18 days showed dose-dependent fat-mass reduction with preservation of lean body mass [11].
• In β3-AR knockout mice, AOD9604 failed to induce lipolysis, confirming β3-AR dependence [1].
• In rabbit collagenase-induced OA, intra-articular AOD9604 improved gross morphological scores from 3.4 to 1.6; combination with HA improved scores to 0.8 [5].

Human Clinical Trials

• Phase 1 tolerability: Single-ascending-dose and multiple-dose studies (up to 24 weeks) demonstrated a reported tolerability profile indistinguishable from placebo. No increases in IGF-1, anti-AOD9604 antibodies, or adverse metabolic markers [15][19].
• Phase 2b (n=536): A large, randomized, double-blind, placebo-controlled trial at oral AOD9604 1–25 mg/day for 24 weeks failed to meet primary weight loss endpoint vs. placebo [16][17].

Regulatory Status

• FDA: Not registered for any medical use. Listed on the FDA Category 2 list [20].
• WADA: Prohibited under Section S2 (Peptide Hormones, Growth Factors) [21].
• Australia (TGA): Approved as a complementary research compound ingredient at low oral doses (2021) [15].