Is AOD 9604 (Anti-Obesity Drug) safe and effective for weight loss?

AOD9604 for Weight Loss: Safety and Efficacy

AOD9604 is not FDA-approved for weight loss and should not be recommended as a safe or effective treatment for obesity. Instead, clinicians should use established FDA-approved medications with proven efficacy and safety profiles.

What is AOD9604?

AOD9604 is a peptide consisting of the C-terminal fragment of human growth hormone (amino acids 177-191) with an additional tyrosine residue at the N-terminus 1. It was developed to potentially mimic the lipolytic (fat-burning) properties of growth hormone without diabetogenic side effects 2, 3.

Safety and Regulatory Status

• Not FDA-approved for any medical use
• Banned by the World Anti-Doping Agency (WADA) as a performance-enhancing substance 1
• Limited human clinical trial data on safety or efficacy
• No long-term safety studies available

Evidence on Efficacy

The only substantial research on AOD9604 comes from preclinical studies:

• Demonstrated some weight loss effects in obese mice after 14 days of treatment 3
• May increase beta-3 adrenergic receptor expression in animal models 3
• No robust clinical trials in humans demonstrating meaningful weight loss

FDA-Approved Alternatives for Weight Loss

Multiple guidelines recommend FDA-approved medications for weight management in appropriate patients:

Indications for Pharmacotherapy

Pharmacotherapy should be considered for patients with:

• BMI ≥30 kg/m² without comorbidities, or
• BMI ≥27 kg/m² with weight-related comorbidities 4, 5

FDA-Approved Options with Proven Efficacy

1. Phentermine (Adipex)

   • Adrenergic agonist
   • Short-term use (FDA-approved for 3 months)
   • Average weight loss: 5.1% at 28 weeks 4
   • Dosage: 15-37.5 mg daily 4

2. Orlistat (Xenical/Alli)

   • Lipase inhibitor
   • Average weight loss: 2.89 kg at 12 months 4
   • Dosage: 120 mg three times daily with meals 4

3. Phentermine/topiramate ER (Qsymia)

   • Combination therapy
   • Average weight loss: 6.6% at 1 year 4
   • Requires gradual dose escalation 4

4. Lorcaserin (Belviq)

   • Serotonin receptor agonist
   • Average weight loss: 3.6% at 1 year 4
   • Dosage: 10 mg twice daily 4

5. Naltrexone/bupropion SR (Contrave)

   • Opioid antagonist/dopamine-norepinephrine reuptake inhibitor
   • Average weight loss: 4.8% at 56 weeks 4, 5
   • Requires gradual dose escalation 4

6. Liraglutide 3.0 mg (Saxenda)

   • GLP-1 analog
   • Average weight loss: 5.4% at 56 weeks 4, 5
   • Particularly useful in patients with type 2 diabetes 5

Comprehensive Approach to Weight Management

All guidelines emphasize that medications should be used as adjuncts to comprehensive lifestyle modification:

1. Dietary Intervention

   • Low-calorie diet creating a deficit of 500-1000 kcal/day 4
   • Fat reduction as a practical way to reduce calories 4

2. Physical Activity

   • Initially 30-40 minutes, 3-5 days per week 4
   • Long-term goal: at least 30 minutes of moderate-intensity activity most days 4

3. Behavioral Therapy

   • Should be used routinely alongside diet and exercise 4

Monitoring and Discontinuation

• Assess efficacy and safety at least monthly for the first 3 months, then every 3 months 4
• Discontinue medication if:
  • <5% weight loss after 12 weeks at maximum tolerated dose 4
  • Serious adverse effects occur 4

Conclusion

AOD9604 should not be used for weight loss as it lacks FDA approval and sufficient clinical evidence for safety and efficacy. Instead, clinicians should recommend evidence-based approaches including lifestyle modifications and, when appropriate, FDA-approved weight loss medications that have demonstrated safety and efficacy in clinical trials.