If you have clinical data showing patient need, the comment docket is the channel, and FDA does read them
**AOD-9604 clinical data:** - One Phase 2b clinical trial was conducted in approximately 300 obese adults in Australia - Results showed **no statistically significant difference** in weight loss between AOD-9604 and placebo groups - The trial was considered a failure, and Metabolic Pharmaceuticals did not advance AOD-9604 to Phase 3 - Total clinical weight loss data in humans: fewer than 500 participants across all studies - Typical AOD-9604 results reported anecdotally: 1-3 kg over several months **Semaglutide clinical data:** - The STEP clinical trial program included over **4,500 participants** across multiple Phase 3 trials - STEP 1 demonstrated **14.9% mean body weight loss** (vs 2.4% placebo) over 68 weeks - STEP 5 confirmed weight loss maintenance of approximately **15.2%** over two full years - STEP 4 showed that discontinuing semaglutide leads to weight regain, confirming its active role in fat loss - The SELECT trial (17,604 participants) demonstrated a **20% reduction in major cardiovascular events** - Total clinical participants: over 20,000 across all weight loss and cardiovascular trials | Metric | AOD-9604 | Semaglutide | |--------|----------|-------------| | Phase 3 weight loss trial | Failed / not completed | Multiple successful trials | | Mean weight loss (%) | Not statistically significant vs placebo | 14.9-16.9% body weight | | Total clinical participants | ~500 | 20,000+ | | FDA approval for weight loss | No | Yes (Wegovy) | | Cardiovascular outcomes data | None | Yes (SELECT trial 20% MACE reduction) | | Long-term data (2+ years) | None | Yes (STEP 5) | | Published in top journals | Limited | NEJM, JAMA, Lancet, Nature Medicine | ### Safety and Side Effects **AOD-9604 side effects:** - Generally well-tolerated in limited studies - Injection site reactions - Headache (infrequent) - No significant GI side effects - **Critical caveat:** The absence of side effects partly reflects the lack of robust biological activity in humans **Semaglutide side effects:** - Nausea (most common, typically transient resolves with dose titration) - Vomiting, diarrhea, constipation - Injection site reactions - Rare reports of pancreatitis - Well-characterized safety profile from extensive clinical trials - Most GI side effects can be managed with proper [dose titration](/guides/semaglutide-dosing-schedule-week-by-week-guide) For guidance on proper **peptide injection** technique to minimize discomfort, see our [GLP-1 injection guide](/guides/how-to-inject-glp1-medications-guide)
If you have persistent tiredness, its a good idea to talk to a healthcare provider to find the root cause
For example, one of our IV Drips can be completed in just a few minutes, providing your body with vitamin B12 and other essential nutrients or vitamins over a very short appointment
First, vitamin B12 has a well-documented role in energy metabolism
Anyone with gut issues : Address conditions like leaky gut or Crohns disease
