AOD-9604

AOD-9604 is a modified fragment of human growth hormone investigated for obesity and fat metabolism. FDA describes it as hGH 177–191 with an added N-terminal tyrosine. The dossier is about evidence and regulatory status, not a treatment recommendation. FDA PCAC briefing material

Clinical evidence

FDA’s 2024 assessment summarizes the randomized, placebo-controlled OPTIONS phase 2b trial using a Metabolic Pharmaceuticals company filing: 536 adults were enrolled, 502 were randomized, and AOD-9604 did not significantly improve weight loss against placebo at the 12-week primary endpoint or at 24 weeks. FDA states that the detailed study design and preliminary efficacy results do not appear to have been published in medical literature. FDA PCAC briefing material

A 2013 paper by Stier and colleagues pools safety observations from six sponsor-funded human studies, including OPTIONS (also called METAOD006). It is a human safety publication, not a full OPTIONS efficacy report or independent efficacy replication. The limited clinical record does not establish AOD-9604 as an effective weight-loss product. A 2010 review supplies historical context rather than original AOD-9604 trial data. Stier et al., 2013, DOI 10.4021/jem157w · Valentino et al., 2010, PMID 20445536

Heffernan and colleagues reported lipid-metabolism findings in obese mice and beta-3-adrenoceptor knockout mice; those findings do not establish human weight-loss efficacy. FDA also reviews preclinical lipolysis and cartilage findings, which do not overcome the negative and incompletely published human efficacy record. No approved indication or validated clinical formulation was verified. Heffernan et al., 2001, PMID 11713213 · FDA PCAC briefing material

Regulatory and sport-status boundaries

FDA lists AOD-9604 among withdrawn nominations that may present significant safety risks when compounded. The agency cites limited safety-related information, possible immunogenicity, peptide-related impurities and active-ingredient characterization problems. This is a quality and safety warning, not an approval or a finding that every marketed product has the same composition. FDA compounding safety page

The 2026 World Anti-Doping Agency Prohibited List names AOD-9604 and hGH 176-191 separately under prohibited growth-hormone fragments. Sport eligibility is rule-dependent and should be checked against the current governing body. WADA 2026 Prohibited List

Interpretation

AOD-9604 remains an unapproved research compound with a failed obesity development program and unresolved product-quality and human-safety questions. Online claims about selective fat loss, HGH-like benefits or a reliable cosmetic/body-composition outcome are not established by the available clinical evidence.

This dossier is a research summary, not medical advice or self-treatment guidance.