Metabolic & Weight Management Phase 2/3 Clinical Trials Completed (Australia) / Research (USA)

AOD-9604

AOD-9604 is a synthetic peptide fragment derived from the C-terminus of human growth hormone (hGH). It was originally developed by Metabolic Pharmaceuticals as an anti-obesity drug candidate and has been studied for fat metabolism and cartilage repair.

Reviewed by Dr. Sarah Kimura, PharmD, BCPS | Last reviewed:

FDA Status
Not FDA-approved as a drug
Research Status
Phase 2/3 Clinical Trials Completed (Australia) / Research (USA)
Common Uses
  • • Fat burning and body composition
  • • Weight management support
  • • Cartilage and joint repair

Medical Disclaimer: This monograph is for educational purposes only. It does not constitute medical advice. AOD-9604 has not been evaluated or approved by the FDA for human use unless noted. Consult a licensed healthcare provider before using any peptide.

What is AOD-9604?

AOD-9604 (Anti-Obesity Drug 9604) is a modified fragment of human growth hormone, specifically the last 15 amino acids of the hGH C-terminus (hGH177-191) with a tyrosine addition at the N-terminus. This fragment retains the fat-reducing properties of full-length growth hormone without the anabolic effects (insulin resistance, IGF-1 stimulation) that make prolonged hGH use problematic.

The peptide was developed in the 1990s by Metabolic Pharmaceuticals in Melbourne, Australia, with the goal of creating an anti-obesity drug that captures GH’s lipolytic (fat-burning) properties selectively.

How AOD-9604 Works

AOD-9604’s mechanism is distinct from full-length growth hormone:

  • Lipolysis stimulation: Activates β3-adrenergic receptors to stimulate fat breakdown, particularly in adipose tissue
  • Lipogenesis inhibition: Reduces the rate at which the body converts food into fat stores
  • No IGF-1 stimulation: Unlike full hGH, AOD-9604 does not significantly raise insulin-like growth factor 1 levels
  • No glucose intolerance: Does not cause the blood sugar dysregulation associated with hGH use
  • Cartilage repair: Preclinical data suggests chondroprotective effects through TGF-beta and proteoglycan synthesis

Research Summary

Obesity and Fat Loss

Multiple Phase 1, 2, and 3 trials in overweight and obese populations were conducted in Australia. Phase 2 results showed statistically significant reduction in body weight versus placebo, particularly in subjects with higher baseline BMI. Phase 3 results were less clear-cut, and Metabolic Pharmaceuticals did not pursue FDA drug approval after Phase 3.

Cartilage and Joint Health

AOD-9604 has been investigated under the name TA-46 for osteoarthritis, with preclinical data suggesting it stimulates cartilage repair through growth factor pathways. Trials for this indication are at earlier stages.

GRAS Status

The 2014 FDA GRAS determination covers AOD-9604 as a food ingredient, which is a relatively unusual regulatory pathway for a peptide. This determination found it safe for consumption at specified doses but does not constitute approval as a drug.

Safety Considerations

  • Among the better-studied research peptides, with Phase 2/3 human data
  • No serious adverse events in clinical trials
  • GRAS status provides additional regulatory validation of safety at specified doses
  • Not approved for prescription or OTC therapeutic use as an injectable

Medical Disclaimer: AOD-9604 is not FDA-approved for drug use. This information is for educational purposes only. Do not use peptides without consulting a licensed healthcare provider.

AOD-9604 occupies an unusual regulatory position: FDA GRAS as a food ingredient, but not approved as a pharmaceutical. In the compounding context, it is not on the FDA’s approved bulk substances list. It is available from research peptide vendors and some international compounding pharmacies.

Safety Profile Summary

AOD-9604 completed Phase 2 and Phase 3 clinical trials in Australia with a favorable safety profile. It was granted FDA GRAS (Generally Recognized As Safe) status for use as a food ingredient in 2014. No serious adverse events were reported in clinical trials.

Stay Informed on Peptide Research

Get the latest peptide research, regulatory updates, and clinical findings delivered to your inbox weekly. No spam — unsubscribe anytime.

No spam. Unsubscribe at any time. See our Privacy Policy.