AOD-9604 progressed beyond animal work into an obesity-development program. FDA’s 2024 review records that the large OPTIONS study did not show statistically significant weight loss versus placebo and that development for obesity was terminated.
What the record shows
- The FDA briefing records 536 enrolled and 502 randomized participants; a reproduced sponsor figure is labelled “All data N=503.”
- Weight loss versus placebo at 12 and 24 weeks was too small to reach statistical significance.
- FDA could not locate a full medical-journal publication with the study methods and preliminary efficacy details.
Study record
The FDA briefing quotes the sponsor’s conclusion that the broader study population did not respond consistently and that the result did not support commercial obesity development. This negative record carries more weight than isolated early signals.
Results in context
The publication gap is important. Without a complete peer-reviewed report, readers cannot independently inspect all prespecified analyses, missing-data handling and subgroup decisions.
AOD-9604 should therefore be described as an investigational GH fragment with a failed obesity-development endpoint—not as a clinically proven “fat-burning peptide.”
What this study cannot answer
The most important large-trial details are in regulatory and company records rather than a full peer-reviewed trial report.
Failure in obesity development does not answer every laboratory question, but it directly contradicts confident human weight-loss claims.
Sources & editorial method
The editorial workflow starts with linked peer-reviewed papers, trial registries or regulatory records; extracts the population or model, endpoints, numerical results and limitations; and separates the studied intervention from catalog material. AI-assisted drafting was used to structure the first version. Claims, figures, evidence labels and limitations were checked against the linked records in the site editorial workflow. This is not independent peer review.
3 linked records are listed in the references below. Read the editorial and AI-assistance policy.
How to interpret this article
Source-checked on 2026-08-28. Null findings and study limitations are retained. This is not independent peer review, medical advice, a customer case, or validation of a catalog lot.
Research-use boundary: Catalog materials discussed on this website are for laboratory research, development and manufacturing use only, not for human or veterinary use. This content is not medical advice and does not provide administration instructions.
Primary records and authoritative sources
- FDA Evaluation of AOD-9604-Related Bulk Drug SubstancesU.S. FDA. December 4, 2024 Pharmacy Compounding Advisory Committee briefing document.
- AOD-9604 development reviewWilding J. Current Opinion in Investigational Drugs. 2004. PMID 15134286.
- FDA December 2024 PCAC meeting recordRegulatory meeting context.
Continue with structured records
Move from this editorial analysis to the product identity, filtered evidence and controlled terminology behind it.
