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What Is AOD-9604?
AOD-9604 (Advanced Obesity Drug-9604) is a modified fragment of human growth hormone (hGH), consisting of amino acids 177-191 of the C-terminal region with an added tyrosine at the N-terminus. Developed by Metabolic Pharmaceuticals in Australia, it was designed to retain the fat-metabolizing properties of hGH without its growth-promoting or diabetogenic effects.
The concept was to isolate the "lipolytic" (fat-burning) activity from a small region of growth hormone, creating a targeted anti-obesity agent.
Key Characteristics
- Origin: C-terminal fragment of human GH
- Target: Fat metabolism without growth effects
- No IGF-1 Increase: Doesn't raise IGF-1 levels
- No Diabetogenic Effect: Doesn't impair glucose tolerance
Mechanism of Action
Fat Metabolism
Proposed mechanisms for fat-reducing effects:
- Stimulates lipolysis (fat breakdown) in adipose tissue
- Inhibits lipogenesis (fat storage)
- May act through ฮฒ3-adrenergic-like pathway
- Does not involve IGF-1 or GH receptor activation
Distinct from Full GH
AOD-9604 differs from growth hormone in important ways:
- No anabolic effects: Doesn't promote muscle or bone growth
- No IGF-1 increase: Doesn't stimulate IGF-1 production
- No insulin resistance: Doesn't impair glucose metabolism
- Targeted effect: Primarily affects fat tissue
Research History
Early Development
- Developed based on research showing the C-terminal of GH has lipolytic activity
- Pre-clinical studies showed fat reduction in obese mice
- Promising animal data led to clinical trials
Clinical Trials
AOD-9604 underwent extensive human testing:
- Phase I: Safety established, no serious adverse effects
- Phase IIa: Some positive signals for fat loss
- Phase IIb/III: Failed to show significant weight loss vs placebo
- Outcome: Obesity indication abandoned by Metabolic Pharmaceuticals
Subsequent Development
- Rights acquired by Calzada Ltd (now Phylogica)
- Repurposed for osteoarthritis research
- TGA approval in Australia for specific compounding use
Clinical Trial Results
| Trial Phase | Participants | Outcome |
|---|---|---|
| Phase I | ~50 | Safe, well-tolerated |
| Phase IIa | ~300 | Modest fat loss signals |
| Phase IIb (oral) | ~500 | Failed primary endpoint |
Current Status and Uses
Australia (TGA)
- Approved for use by compounding pharmacies
- Used in some anti-aging and weight management clinics
- Available as injection or oral formulation
Osteoarthritis Research
- Being investigated for cartilage repair
- May stimulate chondrocyte function
- Early research phase
AOD-9604 vs Fragment 176-191
Comparison
- Fragment 176-191: Unmodified C-terminal fragment of hGH
- AOD-9604: Same fragment with added N-terminal tyrosine
- Difference: Tyrosine modification may improve stability/activity
- Both: Aim to provide lipolysis without GH side effects
Safety Profile
Based on clinical trial data:
- Generally well-tolerated in clinical trials
- No significant adverse events reported
- No effects on blood glucose or insulin
- No cardiac or cardiovascular concerns noted
- No effects on IGF-1 or other growth parameters
Administration
- Routes studied: Subcutaneous injection, oral
- Research doses: 200-500 mcg/day (injection)
- Timing: Often morning, fasted
- Duration: Weeks to months in studies
Why It Failed for Obesity
Despite promising preclinical data:
- Human trials didn't show significant weight loss
- Effect size too small to be clinically meaningful
- Oral bioavailability challenges
- Peptides generally difficult to develop as oral drugs
- Couldn't compete with emerging alternatives (GLP-1s)
Research Status
AOD-9604 is not FDA-approved. While it has TGA approval in Australia for specific compounding use, it failed clinical trials for obesity and remains primarily a research compound in most jurisdictions. The clinical trial failure for its primary intended use (weight loss) is an important consideration.
Summary
AOD-9604 represents an interesting approach to metabolic therapy โ attempting to isolate beneficial fat-metabolizing properties of growth hormone without unwanted effects. While the concept was sound and safety data reassuring, clinical trials failed to demonstrate meaningful weight loss in humans. It serves as a reminder that promising preclinical results don't always translate to clinical success. The peptide continues to be used in some compounding contexts and is being investigated for other applications like osteoarthritis.