AOD-9604 Dosing Guide: Protocol, Reconstitution & Trial Record
AOD-9604 has the most misread trial record in this library. It failed a large oral trial — at doses roughly a hundred times what anyone actually runs, by a route nobody uses. This guide covers what people run subcutaneously, what the trials actually tested, and why those are two different questions.
Also known as Anti-Obesity Drug 9604, hGH Fragment 176-191
AOD-9604 quick start
- Route
- Published human trials used oral and intravenous routes. Subcutaneous injection is the most common research-context format today, though no published human pharmacokinetic study has characterised it.
- Dose context
- 300–500 mcg/day subcutaneous, fasted. Worth noting the trials that failed used oral dosing at 1–30 mg — a different route and roughly a hundred times the dose. The subcutaneous protocol people run has never been formally tested.
- Measure
- At 3.0 mL reconstitution of a 5 mg vial, 1 unit on a U-100 syringe is about 16.7 mcg. A 300 mcg dose is 18 units.
- Cycle context
- Published Phase 2 protocols ran 12–24 weeks. Research-planning structures commonly mirror that length.
- Status
- Not FDA-approved. Development discontinued by the sponsor in 2007 after the Phase 2b trial missed its primary endpoint. Appears on the WADA Prohibited List.
Dosing context and schedule
What follows is drawn from the published record and from what the community has settled on. Reference points, not prescriptions — your situation is yours.
| Phase | Dose | Volume | Units (U-100) | Note |
|---|---|---|---|---|
| Lead-in (weeks 1–4) | 300 mcg/day | 0.18 mL | 18 units | 5 mg vial in 3.0 mL. |
| Continuation (weeks 5–12) | 500 mcg/day | 0.30 mL | 30 units | The upper end of the commonly cited subcutaneous range. |
| Extension | 300–500 mcg/day | 0.18–0.30 mL | 18–30 units | Where a longer structure is used. |
Cycle structures
| Approach | Duration | Review point | Note |
|---|---|---|---|
| Phase 2 trial arm | 12 weeks | Week 12 | A 12-week oral trial in obese adults formed part of the development programme. |
| Phase 2b trial arm | 24 weeks | Weeks 12 and 24 | The pivotal 24-week trial in obese adults did not meet its primary weight-loss endpoint. |
| Research planning | 8–16 weeks | Every 4 weeks | Common community structure. Not derived from a controlled trial. |
What the trials actually say
What people actually run
The converged protocol
300–500 mcg daily, SubQ, fasted, usually in the morning. 3 mL on a 5 mg vial puts 300 mcg at 18 units, which is why that dilution is standard.
Worth being precise about the trial record, because it is widely misread in both directions. The failed studies tested **oral** dosing at 1–30 mg. Nobody runs it that way. The community route is subcutaneous at roughly a hundredth of that dose, and no published human study has ever characterised subcutaneous AOD-9604 — the FDA specifically noted that gap in its December 2024 review.
So the honest position is: oral at high doses did not beat placebo for weight loss, and the route people actually use has never been formally tested. That is a different statement from "it does not work," and also a different statement from "it works."
Reported effects are modest where they are reported at all. People running it as a standalone fat-loss agent are generally disappointed; people running it alongside a GLP-1 or a GH secretagogue tend to describe it as a minor addition.
The safety picture is genuinely good — several hundred trial participants, no meaningful signals, and notably no effect on IGF-1 or fasting glucose. Whatever else is true, this is not a compound people get hurt on.
What the evidence actually says
The honest picture
This one gets misread in both directions, so it is worth being precise. AOD-9604 went through a Phase 2b trial in roughly 500 obese adults and did not beat placebo on weight loss; the sponsor shelved it in 2007. Worth knowing before you buy any.
But that trial used ORAL dosing at 1–30 mg. The route people actually use is subcutaneous at 300–500 mcg, and no published human study has ever looked at it — the FDA specifically flagged that missing data in its December 2024 compounding review. So the accurate read is: oral at high doses did not produce weight loss, and the route in real use has never been tested. That is not "it works" and it is not "it doesn't" — it is genuinely open, and the people running it subcutaneously are the ones finding out.
The safety picture is the reassuring part: several hundred trial participants, no meaningful signals, and no effect on IGF-1 or fasting glucose. Whatever else is uncertain, it is a well-tolerated molecule.
How it is proposed to work
AOD-9604 corresponds to the final residues of human growth hormone — the C-terminal fragment associated with the hormone's effects on fat metabolism — with an added tyrosine for stability.
The development rationale was elegant: isolate the lipolytic activity of growth hormone while leaving behind the effects on IGF-1, blood glucose and tissue growth that make full GH problematic. In animal models the fragment increased lipolysis and reduced fat mass without the metabolic downsides.
The rationale did not survive contact with human trials. Whatever the fragment does in rodent adipose tissue, it did not translate into meaningful weight loss in obese adults at the doses and durations tested.
When to talk to a doctor first
Most people run AOD-9604 without incident. These are the specific situations where it is worth a conversation with a clinician before you start — not reasons to rule it out, but reasons to go in with your eyes open.
- If weight loss is your main goal — set expectations accordingly. The one large human trial did not show meaningful fat loss, and that is the most useful thing to know before you spend money on it.
- If you are pregnant or breastfeeding — no reproductive data exists, so this is one to postpone.
- If you compete in a tested sport — AOD-9604 is prohibited, so it is off the table regardless of how it performs.
- If a GLP-1 is what your situation actually calls for — do not swap it out for this. Semaglutide and tirzepatide have large positive trials behind them; AOD-9604 has a negative one. Different tools, very different track records.
What to expect
Most of what people notice is mild and settles within the first week or two. The list below is ordered by how often it actually comes up, so you know what is routine and what is worth paying attention to.
Common, and usually settles
- Headache — reported more frequently at higher doses in the oral trials.
- Injection site reactions with subcutaneous use.
Less common
- Gastrointestinal effects including diarrhoea, more common at higher oral doses.
- Fatigue.
Rare — stop and get advice
- The trial programme did not surface serious safety signals, which is a genuine point in its favour — the safety profile was acceptable across several hundred participants.
- Notably, AOD-9604 did not produce the increases in IGF-1 or fasting glucose seen with full growth hormone.
Reconstitution guide
AOD-9604 ships as a lyophilised powder and gets mixed with bacteriostatic water before use. How much water you add sets the concentration, which sets how many syringe units make up each dose. One unit on a U-100 syringe is 0.01 mL — the tables below do the arithmetic for the vial sizes you are most likely to be holding.
10mg vial most common
| Water added | Concentration | 300mcg | 500mcg |
|---|---|---|---|
| 2mL (common) | 5 mg/mL | 0.06 mL 6 units | 0.10 mL 10 units |
| 3mL | 3.33 mg/mL | 0.09 mL 9 units | 0.15 mL 15 units |
5mg vial
| Water added | Concentration | 300mcg | 500mcg |
|---|---|---|---|
| 2mL (common) | 2.5 mg/mL | 0.12 mL 12 units | 0.20 mL 20 units |
| 3mL | 1.67 mg/mL | 0.18 mL 18 units | 0.30 mL 30 units |
Standard steps
- Inspect the vialConfirm the label and that the powder cake is intact. Do not use a cracked or compromised vial.
- Let it reach room temperatureSitting out for a few minutes reduces condensation inside the vial when the seal is broken.
- Disinfect both stoppersWipe the compound vial and the bacteriostatic water vial with a fresh alcohol swab and let them air-dry.
- Draw the bacteriostatic waterUse a sterile syringe to draw the volume you have chosen from the reconstitution table.
- Add the water down the vial wallInject slowly so it runs down the inside wall rather than spraying directly onto the powder. This limits foaming.
- Dissolve gentlySwirl or roll the vial between your hands until the cake dissolves. Never shake — agitation damages peptide bonds. The solution should end up clear.
- Label and refrigerateWrite the reconstitution date and concentration on the vial. Store at 2–8°C. Do not freeze.
Timeline and monitoring
- Weeks 1–4The lead-in most people use before stepping up.
- Week 12The first formal review point in the trial programme. In the trials, this is where the efficacy signal failed to separate from placebo.
- Week 24The Phase 2b endpoint. The primary outcome was not met.
- After useNo withdrawal effect described. No suppression of endogenous hormone production.
Bloodwork worth discussing
Markers a clinician may consider relevant before or during a protocol. This is context for a conversation, not a self-ordering list.
| Marker | Why it is relevant |
|---|---|
| IGF-1 | Useful as a baseline. AOD-9604 is not expected to raise IGF-1, unlike growth hormone — confirming that is informative. |
| Fasting glucose and HbA1c | The compound was designed not to disturb glucose metabolism. Worth confirming rather than assuming. |
| Lipid panel | Relevant baseline for anything targeting fat metabolism. |
| Body composition | A DEXA or reliable body composition measure gives you an actual answer rather than an impression. |
Supplies by cycle length
A 5 mg vial provides about 16 days at 300 mcg/day, or 10 days at 500 mcg/day.
| Cycle length | Vials | Syringes | BAC water | Planning note |
|---|---|---|---|---|
| 8 weeks | 5 vials | 56 syringes | 2 × 10 mL bottles | 4 weeks at 300 mcg, then 4 weeks at 500 mcg. |
| 12 weeks | 8 vials | 84 syringes | 3 × 10 mL bottles | 4 weeks at 300 mcg, then 8 weeks at 500 mcg. |
| 16 weeks | 11 vials | 112 syringes | 4 × 10 mL bottles | 4 weeks at 300 mcg, then 12 weeks at 500 mcg. |
What the research record contains
AOD-9604 has a more complete human trial record than most compounds in this library, which makes the outcome more informative rather than less.
Early-phase work established tolerability. A 12-week trial in obese adults explored a wide oral dose range. The pivotal Phase 2b trial ran 24 weeks in roughly 500 obese participants across several oral dose arms.
The Phase 2b trial did not meet its primary endpoint — weight loss was not statistically significant versus placebo. Metabolic Pharmaceuticals discontinued development in 2007 as a result.
A separate line of animal research has examined AOD-9604 in cartilage and osteoarthritis models. That work has not produced human efficacy data.
The FDA reviewed AOD-9604 in the context of compounding in December 2024, and the absence of a characterised subcutaneous pharmacokinetic profile in humans was among the gaps noted.
Storage and handling
- Lyophilised powder: refrigerate at 2–8°C, protected from light.
- Reconstituted: refrigerate at 2–8°C. Do not freeze.
- Commonly used within 30 days of reconstitution when kept refrigerated.
- Label with reconstitution date and concentration.
Troubleshooting
I am not losing weight on it.
That is consistent with the trial record. The Phase 2b study did not show significant weight loss versus placebo, which is why development stopped.
My draw is only 6 units.
You have reconstituted with too little water for comfortable measurement. Using 3.0 mL instead of 1.0 mL puts a 300 mcg dose at 18 units.
Should I combine it with a GLP-1?
People do run it that way. Just be clear which one is doing the work — the GLP-1 carries the evidence, AOD-9604 is the speculative addition.
Oral or injectable?
The human trials used oral and intravenous. Subcutaneous is the common research-context route today but is the least characterised of the three.
Regulatory status
Not approved by the FDA for any indication. Development was discontinued by the sponsor after the Phase 2b failure.
Reviewed by the FDA in the context of bulk drug substances for compounding in December 2024.
Appears on the WADA Prohibited List.
Has been marketed in some jurisdictions as a cosmetic or supplement ingredient. That is a regulatory classification, not evidence of systemic efficacy.
How it compares
| Compared with | Difference that matters |
|---|---|
| Growth hormone | AOD-9604 was designed to isolate GH's fat-metabolism effects without raising IGF-1 or disturbing glucose. It succeeded at avoiding those effects and failed at producing weight loss. |
| Semaglutide / Tirzepatide | Not a comparison in evidentiary terms. GLP-1 and GIP/GLP-1 agonists have large positive Phase 3 trials and regulatory approval for weight management. AOD-9604 has a failed Phase 2b. |
| Tesamorelin | Tesamorelin is FDA-approved for HIV-associated lipodystrophy with real trial data for visceral fat reduction. It is the approved compound in this space. |
Frequently asked questions
Why did development stop?
The 24-week Phase 2b trial in obese adults did not produce statistically significant weight loss compared with placebo. The sponsor discontinued the programme in 2007.
Is it safe?
The safety profile in trials was acceptable, across several hundred participants — better characterised than most compounds here. Safety was not the reason development stopped.
Does it raise IGF-1?
No. Avoiding that was the design goal, and on that measure the molecule did what it was intended to do.
Why do people still use it?
Marketing, largely, plus the appeal of the original rationale. The mechanism story is genuinely elegant. The human results simply did not follow.
Is it worth trying anyway?
That is your call to make, but make it knowing the best available human evidence is a negative trial rather than an absence of trials.
References
- Metabolic Pharmaceuticals Phase 2b (OPTIONS) trial — primary endpoint not met, development discontinuedSponsor announcement, 2007
- FDA review of bulk drug substances for compoundingU.S. Food and Drug Administration, December 2024
- WADA Prohibited ListWorld Anti-Doping Agency
This page is an educational research reference and is not medical advice. AOD-9604 is not approved for human use in any jurisdiction. Dose figures reflect the published record and what the community has converged on — starting points to weigh, not instructions. Consult a qualified healthcare provider before starting any protocol.