AOD-9604 underwent an oral obesity development programme. FDA's 2024 evidence review describes a 502-person randomized 24-week OPTIONS trial that found no statistically significant weight-loss difference versus placebo; an earlier 300-person dose-ranging study produced only small differences of unclear clinical importance.
Regulatory status
Not FDA-approved; FDA has raised compounding safety concerns.
Main limitations
Clinically meaningful weight-loss efficacy, long-term safety, injectable efficacy or a validated chronic-use regimen.
Safety
FDA cites limited safety information, potential immunogenicity/impurity issues and serious adverse events that may be associated, with causality unclear.
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AOD-9604 underwent an oral obesity development programme. FDA's 2024 evidence review describes a 502-person randomized 24-week OPTIONS trial that found no statistically significant weight-loss difference versus placebo; an earlier 300-person dose-ranging study produced only small differences of unclear clinical import…
What the evidence actually supports
✓This negative human trial should dominate over favorable animal marketing claims.
What is not established / key limitations
×No significant weight-loss advantage in the 502-person OPTIONS study.
Selected study & evidence records
FDA-reviewed 12-week oral AOD-9604 obesity study
2005 · Randomized double-blind placebo-controlled dose-ranging study · n=300
FDA review notes only small between-group differences with unclear clinical importance and limited published detail.
FDA cites limited safety information, potential immunogenicity/impurity issues and serious adverse events that may be associated, with causality unclear.
FDA cites limited safety information, potential immunogenicity/peptide-impurity concerns and serious adverse events reported in the programme with uncertain causality. Human non-oral route data are especially sparse.
Technical details
Mechanism / biologyC-terminal human growth-hormone fragment 177–191 with an added N-terminal tyrosine; developed to explore lipolytic effects without full GH activity.
Route / formulation boundaryResearch findings depend on verified AOD-9604 identity and route.
Identity / data-quality noteUse the canonical compound identity and studied formulation when interpreting evidence.
Dosing evidence statusHistorical human trial dosing verified. The Phase 2b OPTIONS programme studied oral 0.25 mg, 0.5 mg and 1 mg once daily for 24 weeks. The programme did not establish an approved therapeutic dose and should not be used to justify injectable marketplace protocols.
Identifiers & alternate namesAOD9604 · AOD 9604
Evidence rule: WhichPeps keeps human, animal, laboratory, regulatory and product/formulation evidence distinct. Common names help people find the page; they do not change the underlying scientific identity.
