Ask VialBase
Development history summary

AOD-9604 Phase IIb Obesity Trial and Development History — VialBase Research

Phase IIb RCT with 300+ patients for oral AOD-9604 (1mg/day)

Last updated · 2004-2007 · Metabolic Pharmaceuticals (now Calzada Ltd) · Company/regulatory filings
Key findings
  • Phase IIb RCT with 300+ patients for oral AOD-9604 (1mg/day)
  • Statistically significant weight loss vs placebo (~2.5 kg over 12 weeks)
  • No effects on IGF-1, glucose, insulin, or cortisol
  • Excellent safety profile -- no significant AEs beyond placebo
  • Did not advance to Phase III due to commercial viability (not safety)
  • FDA GRAS status granted 2013 for food ingredient use

AOD-9604 Phase IIb Obesity Trial

Development Timeline

  • 1990s: GH fragment 176-191 identified as lipolytic domain of human growth hormone
  • 2001-2004: Metabolic Pharmaceuticals (Melbourne, Australia) developed AOD-9604
  • 2004-2007: Phase IIb clinical trial for obesity
  • ~2007: Program discontinued (commercial decision)
  • 2013: FDA GRAS status granted for food ingredient

Phase IIb Trial Details

  • Design: Randomized, double-blind, placebo-controlled
  • Size: 300+ patients
  • Dose: 1 mg/day oral
  • Duration: 12 weeks
  • Primary endpoint: Weight loss

Results

  • Efficacy: Statistically significant weight loss (~2.5 kg vs placebo)
  • Magnitude: Modest — insufficient for standalone obesity therapy in GLP-1 era
  • Safety: Clean profile — no IGF-1, glucose, insulin, or cortisol changes
  • Adverse events: No significant AEs beyond placebo rate

Why It Stopped

  • Commercial viability assessment: 2.5 kg weight loss over 12 weeks was considered commercially insufficient, especially against emerging obesity therapies
  • NOT stopped for safety reasons
  • The safety data was strong enough to later support GRAS determination

Relevance

AOD-9604 has the unusual distinction of having FDA GRAS status (safety validated) without drug approval (efficacy insufficient for standalone use). In the context of peptide stacking and combination protocols, its clean safety profile makes it attractive as an adjunct rather than primary obesity therapy.

See Also