For research and educational purposes only. Not medical advice.
AOD-9604 Reference
Educational, not medical advice reference for AOD-9604: Fat Loss; regulatory status, evidence posture, source review, and schedule notes. Also k…
Reference summary
AOD-9604 is a synthetic analog of human growth hormone residues 176-191 with an added N-terminal tyrosine; the parent-sequence cysteines (Cys182 and Cys189) are retained and the disulfide bridge between them is formed during solid-phase synthesis. The preclinical lipolytic literature in rodent adipocytes is reproducible (Heffernan 2001 Int J Obes Relat Metab Disord, PMID 11673763; Heffernan 2001 Endocrinology, PMID 11713213, beta3-AR knockout work showed the lipolytic effect is not strictly mediated through beta3-AR). The pivotal Phase 2b program in obese adults (Metabolic Pharmaceuticals, with a 12-week primary endpoint inside a 24-week treatment period; 536-subject scale reported in pharmacotherapy reviews) did not produce clinically meaningful weight loss versus placebo and fell well short of the FDA's roughly 5 percent placebo-adjusted threshold for obesity-drug approval. The sponsor terminated the obesity program in 2007. No Phase 3 obesity trial advanced.
Regulatory and posture
- Categories
- Fat Loss
- Aliases
- hGH fragment 176-191 analog, AOD, LAT8881, Anti-obesity drug 9604
- Evidence posture
- human - Human trials did not support obesity approval; the pivotal Phase 2b weight-loss effect versus placebo was small and the obesity program was terminated in 2007. Reproducible rodent lipolytic mechanism; modern GLP-1-class comparators set a far higher bar.
- Regulatory status
- No FDA-approved AOD-9604 drug label. Originally developed by Metabolic Pharmaceuticals (Australia) out of work at Monash University (Frank Ng lab) as a fat-loss candidate; the obesity program was terminated in 2007 after the pivotal Phase 2b efficacy readout did not reach the regulatory bar. Subsequent IP assignment to Lateral Pharmaceuticals reintroduced the molecule under the alias LAT8881. A sponsor-claimed self-affirmed GRAS (generally recognized as safe) conclusion has been published for food-ingredient applications in the US; no corresponding FDA 'no questions' letter is on record. FDA lists AOD-9604 among bulk substances with safety-risk concerns.
- Content review status
- research reference
Selected public sources
- FDA bulk drug substances with significant safety risks
- ClinicalTrials: LAT8881/AOD9604 protocol
- PubMed search: AOD-9604 Phase 2b obesity randomized placebo controlled trial literature
- PubMed: Heffernan MA, Thorburn AW, Fam B, et al. Increase of fat oxidation and weight loss in obese mice caused by chronic treatment with human growth hormone or a modified C-terminal fragment (AOD-9604). Int J Obes Relat Metab Disord 2001;25(10):1442-9 (PMID 11673763)
- PubMed: Heffernan M, Summers RJ, Thorburn A, et al. The effects of human GH and its lipolytic fragment (AOD9604) on lipid metabolism following chronic treatment in obese mice and beta3-AR knock-out mice. Endocrinology 2001;142(12):5182-9 (PMID 11713213) - beta3-AR knockout showed lipolytic action is not directly mediated through beta3-AR
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