AoHuman trials

AOD-9604 protocol

AOD-9604 is a short peptide based on a piece of growth hormone. Its makers tested it as a pill for obesity in the 2000s. It is not an approved medicine.

Not an approved medicine for any useCompany-sponsored human trials were oral; no injection trial found
ProtocolMixingResultsSide effectsHow it worksSources

The protocol at a glance

There is no proven human dose for injections. The company's human trials gave it by mouth or by single IV doses, and their weight-loss results were not found in a published paper.

Route studiedAmount in the human trials
Human injection doseNot established
Phase 1 / 2a, single IV dose25 to 400 mcg per kg of body weight
Phase 2a, oral capsules9, 27 or 54 mg, single or daily for 7 days
Phase 2b, oral capsules, 12 weeks1, 5, 10, 20 or 30 mg daily (300 adults)
Phase 2b, oral tablets, 24 weeks0.25, 0.5 or 1 mg daily (502 adults)

From Stier H et al. J Endocrinol Metab 2013, a safety summary of six company trials. It does not report weight-loss results. These are trial schedules, not a label.

Community reports

Community protocols describe daily or twice-daily injections of a few hundred micrograms for a few weeks. No trial I found used that.

What people say they do, collected from community discussions. Not tested in a trial; shown so you can compare it with the evidence above.

Mixing

No mixing table here: this one is used as a capsule, nasal spray or skin product, or has no human amount to calculate from. The general mixing calculator works for any vial.

What the trials found

No weight-loss numbers were found in a published paper. The safety paper covers six company trials. What it does show:

893people in six company trials
3.6%had a serious adverse event in the 24-week trial (18 of 502), spread evenly across groups
0published weight-loss results found

Stier H, Vos E, Kenley D. J Endocrinol Metab 2013;3:7-15. Authors were linked to the sponsor. Secondary reports say the larger phase 2b did not meet its weight goal; I could not confirm that in a primary source.

Side effects

  • In the 54 mg oral trial, headaches, diarrhea and gas were more common.
  • In the 300-person trial, five serious events were reported (including several cancers). The investigators judged none were related to the drug. No changes were seen in IGF-1 or glucose tolerance tests.

How it works

Fat breakdown (proposed)

It is a fragment of human growth hormone. The idea is that it boosts fat breakdown without the other effects of growth hormone. The safety paper found no change in IGF-1.

Sources

  • Stier H, Vos E, Kenley D. Safety and tolerability of the hexadecapeptide AOD9604 in humans. J Endocrinol Metab 2013;3(1-2):7-15
  • Drug testing and analysis 2013: AOD-9604 does not influence the WADA hGH isoform immunoassay (PubMed 24124033)