AOD 9604 Dosage: Trial Doses, Timing and Cycling Evidence

What Is the Standard AOD 9604 Dosage?

No standard AOD 9604 dosage exists, because no FDA-approved medicine contains it. In people, it was tested only by mouth or injected into a vein (IV). The largest trial gave 0.25, 0.5 or 1 mg by mouth once a day for 24 weeks. It did not beat a dummy pill (placebo) on weight.

AOD 9604 is a 16-amino-acid synthetic peptide. FDA describes it as amino acids 177 to 191 of human growth hormone (hGH), with one extra amino acid, tyrosine, added. FDA briefing, 4 December 2024

It was developed as a possible oral obesity drug. In rodent studies it raised fat breakdown without the blood sugar effects of growth hormone. In cell tests it did not bind the growth hormone receptor. Its developer, Metabolic Pharmaceuticals, ended work on it for obesity in 2007.

This guide sets out every dose tested in people, what each trial found, and where the evidence stops. No dose is established for fat loss, joints or any other use. Every figure below comes from a named study or from FDA's own review, cited inline.

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How Does AOD 9604 Work on Fat Cells?

Nobody knows for certain. FDA's 2024 review says its molecular target and mechanism "remain unknown". The rodent work below is what the idea rests on. FDA briefing, 4 December 2024

Full-length human growth hormone binds the growth hormone receptor and makes some cells grow. In cell tests, AOD 9604 did not compete for that receptor. It did not make those cells grow either. Heffernan 2001b

The 2002 patent credits its effect to diacylglycerol, a signal molecule inside the cell. It says fat use rose and fat production fell "in vitro as well as in vivo". Its weight experiments used obese (ob/ob) mice. Ng 2002.

Lipolysis means the breakdown of stored fat. In a rodent (mouse) study, obese mice got AOD 9604 for 14 days from a small pump. Fat burning and plasma glycerol, a marker of lipolysis, both rose. Unlike growth hormone, it did not raise blood sugar or cut insulin release. Heffernan 2001b

FDA's review adds that it cut lipogenesis, the laying down of new fat, in rodent (mouse) and rodent (rat) studies. FDA briefing, 4 December 2024

In a rodent (rat) study, obese Zucker rats took 500 mcg/kg by mouth each day for 19 days. They gained over 50% less weight than untreated rats. Unlike intact growth hormone, it did no harm to insulin sensitivity. Ng et al. 2000.

A second rodent (mouse) study looked at the beta-3 receptor, a fat-cell receptor that triggers fat breakdown. In mice bred without it, 14 days of AOD 9604 had no effect on weight or fat breakdown. In a short, acute test, it still raised energy use and fat burning in those mice. From that, the authors concluded it does not act directly through that receptor. Heffernan 2001a

FDA reads the same study differently. It says the fat-breakdown effect seems to depend "at least in part" on the beta-3 receptor. FDA briefing, 4 December 2024.

FDA adds a warning about all of this work. None of these rodent studies tested how the effect changes with dose.

What Did the Trials Show at Each AOD 9604 Daily Dosage?

The human data is small. FDA's verdict: "In most of the studies we identified, AOD-9604 failed to show benefit for weight reduction when compared to placebo." A 2013 summary by the sponsor's own staff and advisers covers six trials. FDA believes the trial reports it found elsewhere describe these same trials. Each is described as randomised, double-blind and placebo-controlled. Randomised means chance decided who got the drug. Double-blind means neither staff nor volunteers knew who did. FDA briefing, 4 December 2024

The 12-week trial's weight results come only from a meeting abstract. On 1 mg a day, weight fell by 0.22 kg a week. On placebo it fell by 0.07 kg a week. At 20 mg and 30 mg the rates were 0.13 and 0.15 kg a week. The abstract gave no weight data for 5 mg or 10 mg.

The authors called the dose response "non-linear". FDA said the claim rests on small gaps with unclear benefit. It found no full publication of the study. FDA briefing, 4 December 2024

The later Phase IIb OPTIONS trial enrolled 536 people and randomised 502. Phase IIb is a mid-stage trial that compares doses before a final large trial. It ran for 24 weeks. Every group also followed a diet and exercise programme run by a dietitian.

Its primary endpoints, the main results a trial is built to test, were weight loss at 12 weeks and safety. The weight loss endpoint was not met. On 21 February 2007, the company said the results "do not support the commercial viability" of the drug for obesity. FDA briefing, 4 December 2024.

Three points follow for anyone reading the dose data:

• Every dose tested in people was given by mouth or by IV. FDA found no human data for an injection under the skin.
• The largest trial, at 1 mg a day or less, found no significant weight loss against placebo.
• The 20 mg and 30 mg doses did no better than 1 mg in the 12-week trial. They lost 0.13 and 0.15 kg a week, against 0.22 kg on 1 mg.

Is There an AOD 9604 Dosage Chart Backed by Trials?

No. The only chart the evidence supports is the trial table above. It lists what was tested, not what works.

No human trial tested AOD 9604 as an injection under the skin. FDA found no such data when it reviewed the drug in 2024. Clinic websites it reviewed listed a 600 mcg/mL 10 mL vial, a 1 mg capsule and a 250 mcg daily melt. FDA briefing, 4 December 2024

So a chart that gives a dose for a shot under the skin is not drawn from a human study.

Is There an AOD 9604 Dosage Per Day for Beginners?

No. A starting dose would need a trial that tested one, and none did for a shot under the skin. The oral trials gave fixed doses by mouth, from 0.25 mg up to 54 mg (60 mg in one account).

Those numbers do not carry over to a shot. FDA found no human data on how the body absorbs AOD 9604 by any route. It also found no human data at all for a shot under the skin.

The 12-week abstract reported different effects in men and women. It called the 1 mg result "significant" for women.

What Does an AOD 9604 Dosage Protocol by Injection Rest On?

Not on trial data for a shot under the skin. FDA found no human exposure data for AOD 9604 given under the skin or rubbed on as a cream. Its review lists no study of a nasal spray either.

The morning, fasted routine comes from clinics, not studies. FDA noted that some clinic websites advise a shot 30 minutes before eating. No trial has tested timing, fasting or injection site for AOD 9604.

FDA also flagged the immune system. A shot under the skin tends to provoke a stronger immune response than an IV dose. FDA could not rule out that risk for AOD 9604. FDA briefing, 4 December 2024

Our guide to injecting peptides covers the technique in general. It does not supply a dose for this compound.

Is There an AOD 9604 Dosage Calculator?

A calculator can only do arithmetic on a dose you give it. For AOD 9604 there is no tested dose for a shot under the skin to start from.

Human doses were not all flat either. The IV trials dosed by body weight, in mcg per kg. The oral trials used fixed doses in mg. The rodent (rat) study used 500 mcg/kg a day by mouth. No published human data backs reading a rat dose across by body weight.

Does AOD Cardio in a Fasted State Help?

No study has tested it. No controlled human trial has paired AOD 9604 with fasted exercise.

The closest test in people is the OPTIONS trial. Every group in it also followed a diet and exercise programme run by a dietitian. AOD 9604 still did not beat placebo on weight at 12 weeks. FDA briefing, 4 December 2024

Our look at AOD 9604 and fat loss covers what the outcome data does and does not show.

How Long Did the Trials Run, and Is There an AOD Cycle?

The longest human trial gave AOD 9604 daily for 24 weeks. It followed a 4-week run-in, a lead-in period on placebo. The 12-week trial followed a 2-week run-in. No study has tested an AOD cycle of time on and time off.

No study has tested whether breaks change its effect or its safety in people.

There is no published human safety data past 24 weeks. That is a real gap, not a technicality.

What Did the Trials Record on AOD 9604 Safety?

The main safety record is the 2013 summary of the six trials. Its authors worked for or advised the company that paid for them. FDA briefing, 4 December 2024

In every study they reported no significant IGF-1 difference against placebo. IGF-1 is a growth factor made in response to growth hormone. No antibodies to the drug turned up in the people tested for them. Lab tests, heart tracings (ECG) and vital signs showed no significant changes.

Serious events did occur. In the 12-week trial, five people on the drug reported them. They were basal cell and squamous cell skin cancers, a lipoma (a fatty lump), breast cancer and malignant melanoma. The lead investigator judged none of them related to the drug. FDA said there was not enough detail to tell.

In one oral trial, a serious case of diarrhoea at 54 mg was judged possibly related. In an IV trial, a severe feeling of chest tightness was judged possibly related. So was mild to moderate euphoria, a strong sense of well-being.

Animal toxicity work raised flags too. In a rodent (rat) study over 26 weeks, a bone marker shifted with dose. In a nine-month monkey study, liver cells showed minor changes that FDA said could signal damage.

How that differs from full-length hGH:

• No significant IGF-1 change in the trials, per the sponsor's summary. FDA found no animal data backing the claim that it leaves IGF-1 alone.
• No high blood sugar in a rodent (mouse) study, even where fat burning rose. Heffernan 2001b.
• Insulin sensitivity held in a rodent (rat) clamp test, which measures how well insulin works. Intact growth hormone harmed it. Ng et al. 2000
• No antibodies found in the trial groups tested. FDA still judged that a peptide of this length could trigger an immune response.

What is missing is long-term human safety past 24 weeks. The trial programme ended in 2007. Anyone running longer is working in an evidence gap.

Can AOD 9604 Help Cartilage and Joints?

One rabbit study says maybe.

A 2015 study gave 32 rabbits knee osteoarthritis, the wear-and-tear joint disease, using an enzyme. Each week, the knees were injected with saline, AOD 9604 at 0.25 mg, hyaluronic acid at 6 mg, or both. Kwon and Park 2015

Hyaluronic acid is a gel-like substance found in joint fluid. The weekly shots ran for 4 to 7 weeks after the first enzyme injection. AOD 9604 improved cartilage scores against saline. The pair did better than either one alone.

This is early data from a single animal model. No human trial on AOD 9604 for joint health has been published. It is an area of interest, not a proven use. FDA did not review it for osteoarthritis. The nominations lacked the data, and FDA found no human studies in that use.

Is AOD 9604 Legal, and Where Do You Get It?

AOD 9604 is not FDA-approved for any therapeutic use. In 2007 its developer ended development for obesity, after the Phase IIb trial missed its primary endpoint. No FDA-approved medicine contains it.

Compounding means a pharmacy mixing a drug for a named patient. Under section 503A of US drug law, a pharmacy may compound from a bulk ingredient only in set cases. One is a place on FDA's 503A bulks list. That list holds six substances, none of them peptides, and AOD 9604 is not on it. 21 CFR 216.23

FDA's category list updated on 29 September 2023 added AOD 9604 to Category 2. FDA heads that category "Bulk Drug Substances that Raise Significant Safety Risks". FDA 503A category list, updated 29 September 2023.

Its update of 27 September 2024 removed AOD 9604 from Category 2 "because the nominations were withdrawn by the nominators". FDA 503A category list, updated 27 September 2024.

In December 2024 FDA briefed its Pharmacy Compounding Advisory Committee on it. The committee voted 12 to 0 against adding it to the 503A bulks list. FDA PCAC minutes, 4 December 2024

FDA's own review had proposed not listing it. It cited three grounds. The substance is not well characterised, physically and chemically. There is a lack of evidence that it works for obesity, and too little safety data. FDA briefing, 4 December 2024.

In a 2024 warning letter to one peptide seller, FDA said a "research use only" label did not stop its products being unapproved drugs. That letter concerned semaglutide, tirzepatide and three other products, not AOD 9604. FDA warning letter, 10 December 2024

The mechanism is interesting. The benefit case did not survive its own Phase IIb test.

On sourcing, the supplier matters. A third-party certificate of analysis from an accredited lab is the minimum we look for.

For a look at growth hormone-adjacent peptides used in body composition research, our tesamorelin versus ipamorelin breakdown covers two growth hormone secretagogues. They act on the pituitary gland, a different route from AOD 9604.

References

1. Ng FM et al. (2000). Metabolic Studies of a Synthetic Lipolytic Domain (AOD9604) of Human Growth Hormone. Horm Res.
2. Heffernan MA et al. (2001). Increase of Fat Oxidation and Weight Loss in Obese Mice Caused by Chronic Treatment with Human Growth Hormone or a Modified C-terminal Fragment. Int J Obes Relat Metab Disord.
3. Heffernan M et al. (2001). The Effects of Human GH and Its Lipolytic Fragment (AOD9604) on Lipid Metabolism Following Chronic Treatment in Obese Mice and beta(3)-AR Knock-out Mice. Endocrinology.
4. FDA. (2024). Briefing Document: PCAC Meeting, 4 December 2024. Evaluation of AOD-9604-related bulk drug substances.
5. FDA. (2024). Final Summary Minutes of the Pharmacy Compounding Advisory Committee Meeting, 4 December 2024.
6. Kwon DR, Park GY. (2015). Effect of Intra-articular Injection of AOD9604 with or without Hyaluronic Acid in Rabbit Osteoarthritis Model. Ann Clin Lab Sci.
7. Ng FM et al. (2002). Treatment of Obesity. U.S. Patent 6,335,319.
8. FDA. (2024). Warning Letter: Summit Research Peptides, 10 December 2024.

This content is for educational purposes only. These compounds are intended for research use. Nothing here is medical advice. Always work with a qualified clinician before making changes to your health protocol.