Short answer: AOD-9604 is the rare research peptide that went through six human trials with close to 900 participants. The good news: its safety profile was described as indistinguishable from placebo, with no change in IGF-1 or blood sugar. The bad news: in the largest trial, it did not produce weight loss that was statistically different from placebo, and its developer abandoned it for obesity in 2007. Here is the full trial history.
What AOD-9604 is
AOD-9604 is a 16-amino-acid fragment of human growth hormone (residues 176–191). It was developed in the 1990s by Monash University researchers and the Australian company Metabolic Pharmaceuticals, with one goal: keep growth hormone’s fat-burning effect while dropping its effects on growth, IGF-1 and blood sugar. In obese mice, it reduced fat without those side effects.
The six human trials
| Trial | Phase | Participants | Result |
|---|---|---|---|
| METAOD001–004 | I–IIa | About 90, IV and oral | Well tolerated |
| METAOD005 | IIb | 300, oral, 12 weeks | 1 mg: −2.8 kg vs −0.8 kg placebo |
| METAOD006 (OPTIONS) | IIb | 536, oral, 24 weeks | No dose significantly better than placebo |
In February 2007, Metabolic Pharmaceuticals announced that the results did not support commercial viability for obesity and stopped development. Note that these trials used oral AOD-9604; most research vials today are for injection, which was tested only in early single-dose studies.
Side effects and safety
A 2013 safety review of the human program concluded that AOD-9604 had “a very good safety and tolerability profile indistinguishable from placebo”:
- No change in IGF-1 across trials.
- No impairment of glucose tolerance or insulin sensitivity.
- No anti-drug antibodies detected.
- No drug-related serious adverse events.
Users of injectable AOD-9604 commonly mention injection-site redness or mild headache; these are anecdotal. The bigger issue is not harm but effect: the best human evidence says it does not reliably cause weight loss.
GRAS, FDA and WADA
| FDA (USA) | Not an approved drug. It obtained GRAS status as a food ingredient (which does not establish effectiveness). In December 2024, the FDA decided it should not be added to the list of substances pharmacies may compound, citing limited long-term safety data, impurities and immunogenicity concerns. |
|---|---|
| Health Canada | Not authorized as a drug. AOD-9604 was among products seized from Canada Peptide in 2025. |
| WADA | Prohibited, under S0 and S2. |
See TrueLabs AOD-9604 and its COA →
Frequently asked questions
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What are the side effects of AOD-9604?
Across six human trials with close to 900 participants, its safety profile was described as indistinguishable from placebo, with no changes in IGF-1 or blood sugar and no drug-related serious adverse events.
Does AOD-9604 work for weight loss?
One 12-week trial showed a small benefit at 1 mg, but the larger 24-week trial found no dose significantly better than placebo, and development for obesity was stopped in 2007.
Is AOD-9604 the same as HGH fragment 176-191?
AOD-9604 is a modified version of the hGH 176–191 fragment. The two names are often used interchangeably.
Is AOD-9604 FDA approved?
No. It has GRAS status as a food ingredient, but it is not an approved drug, and in 2024 the FDA declined to add it to the compounding list.
Is AOD-9604 banned in sport?
Yes. WADA prohibits it.
Related reading
- What is AOD-9604? The full trial history
- Cagrilintide and CagriSema: what REDEFINE 1 showed
- Tirzepatide side effects
- How to read a peptide COA
References
- Stier H, Vos E, Kenley D. Safety and tolerability of the hexadecapeptide AOD9604 in humans. J Endocrinol Metab. 2013;3(1-2):7–15. JOFEM
- Heffernan M, et al. The effects of human GH and its lipolytic fragment (AOD9604) on lipid metabolism following chronic treatment in obese mice. Endocrinology. 2001;142(12):5182–5189. PubMed
- FDA Pharmacy Compounding Advisory Committee, December 4, 2024. FDA
- WADA statement on substance AOD-9604. WADA
All TrueLabs products are sold for in vitro and laboratory research use only. They are not intended for human or veterinary use, and nothing in this article is medical advice.