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Because it lacks long-term human clinical trials, the full long-term side effect profile is unknown

Second, unlike full-length growth hormone, AOD-9604 does not bind to growth hormone receptors present throughout the body

Published Phase 2 clinical trial data used doses of 1mg, 4mg, 8mg, and 12mg administered weekly via subcutaneous injection

Metaanalysis demonstrates clinical benefit with reduction in disease activity

REDEFINE 2 Trial Type 2 Diabetes with Obesity The companion REDEFINE 2 trial, also published in 2025, enrolled 1,206 adults with type 2 diabetes and obesity or overweight, demonstrating the combinations efficacy in this more metabolically compromised population: Mean weight loss of 13.7% compared to 3.4% with placebo over 68 weeks 73.5% achieved hemoglobin A1c of 6.5% or less compared to 15.9% with placebo Greater proportions reaching multiple weight thresholds including 5%, 10%, 15%, and 20% reduction Significant glycemic improvement with mean A1c reduction demonstrating disease modification potential Favorable metabolic profile changes including improvements in blood pressure and lipids These findings established that the combination maintains substantial efficacy even in patients with the metabolic dysfunction of established type 2 diabetes, a population often showing reduced response to weight-loss interventions