Peptide Checkup

Compound record · Growth hormone axis

AOD-9604

Also AOD9604 · hGH fragment 176-191 · Tyr-hGH 177-191 · Anti-Obesity Drug 9604 · Advanced Obesity Drug

Synthetic C-terminal fragment of human growth hormone

Growth hormone axisEvidence · InsufficientEarly-stage human studiesWADA · Prohibited at all times

Failed obesity drug candidate now sold without authorisation; WADA-prohibited

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Record reviewed 1 September 2026 · 5 references

Status
Not authorised anywhere; development abandoned 2007
Class
Synthetic hGH fragment (Tyr-hGH 177–191)
Human trials
6 trials, 893 participants (2001–2006); no significant weight loss
WADA
Prohibited at all times (S2, growth hormone fragments)
Route
Sold as injection or oral; only oral and intravenous dosing studied

01 Overview

What AOD-9604 is

Summary

AOD-9604 is a modified 16-amino-acid fragment of the C-terminus of human growth hormone (Tyr-hGH 177–191), developed by Metabolic Pharmaceuticals in Australia as an oral anti-obesity drug in the early 2000s. It was designed to keep growth hormone's fat-mobilising effect without raising IGF-1, but a 24-week phase 2b trial in 536 adults with obesity found no significant weight loss versus placebo and development was terminated in 2007. It is not authorised anywhere; injectable and oral versions are sold by unregulated vendors, and it is prohibited in sport.

Mechanism

Proposed to stimulate fat breakdown (lipolysis) and inhibit fat storage through a mechanism independent of the growth hormone receptor and IGF-1, possibly via β3-adrenergic signalling in rodent fat tissue. Human trials confirmed it does not raise IGF-1 or impair glucose tolerance, but also did not show meaningful fat or weight loss.

Routes studiedOral, Subcutaneous injection
Anti-dopingProhibited at all times

02 Evidence by goal

What has been shown, for which goal

Grades follow one scale across the site. Insufficient overall means: no reliable human evidence for this use — animal or laboratory data only.

  1. Fat loss / body composition

    Insufficient

    The controlled human evidence is negative: a 24-week trial (536 enrolled; oral 0.25–1 mg daily) found no significant weight loss versus placebo, and a 12-week trial (n ≈ 300; 1–30 mg daily) reported only small, non-dose-dependent differences that were never published in full. Fat-mobilising effects are documented in rodents and in short human studies measuring free fatty acids, not fat loss.

  2. Weight management

    Insufficient

    Development for obesity was abandoned in 2007 after the phase 2b trial failed its primary endpoint; the FDA's 2024 review concluded there is a lack of evidence of effectiveness for obesity by any route.

  3. Injury & recovery support

    Insufficient

    Marketed for cartilage and joint repair on the basis of a rabbit osteoarthritis model (intra-articular injection with hyaluronic acid); there are no human studies for this use.

03 Regulatory status

Where it is authorised, and for what

Status is recorded per jurisdiction from regulator sources and reviewed by hand. It is never inferred from another region's decision.

United Kingdom

Not authorised

Not authorised as a medicine; sold only as an unregulated 'research chemical'.

No MHRA marketing authorisation. Supplying it as a medicine for human use without a licence is unlawful; online sellers label it 'not for human consumption' to sit outside medicines regulation, so there is no quality assurance.

StatusNot authorised
Status last reviewed1 September 2026
SourceOur maintained database — never inferred

04 Dosing research

What the evidence says about exposure

Published human studies and the doses, routes and durations they used — reported as research information, not a recommendation.

Research information — not a recommendation. These are the exposures used in published human studies, reported so you can see what has been tested. They are not dosing instructions and do not apply to any individual.

Study 01

Pooled safety analysis of six sponsor-funded AOD9604 trials (2001–2006)

Stier H, Vos E, Kenley D. J Endocrinol Metab 2013;3:7–15 · Source

Pooled phase 1–2b2013
Design
Six randomised, double-blind, placebo-controlled trials (pooled safety analysis; sponsor-funded)
Population
Healthy men and adults with obesity
Participants
n = 893
Duration
Single doses to 24 weeks
Route
Oral
Doses studied
Intravenous 25–400 mcg/kg single doses; oral 9–54 mg single and 7-day doses; oral 1–30 mg daily for 12 weeks; oral 0.25–1 mg daily for 24 weeks
Outcome at this exposure
Safety analysis only: no effect on IGF-1 or glucose tolerance, no anti-AOD9604 antibodies detected, and no withdrawals or serious adverse events judged related to treatment. Efficacy was not reported; the two long-term trials did not show significant weight loss.
Adverse events observed
Headache, diarrhoea and flatulence (oral); headache, fatigue and dizziness (intravenous); severe chest tightness and euphoria judged possibly related after intravenous dosing; several cancers occurred in the 12-week trial and were judged unrelated by investigators. The FDA's 2024 review noted the paper lacks detail on methods and results.

Study 02

OPTIONS phase 2b — oral AOD9604 in adults with obesity (unpublished, company-reported)

Metabolic Pharmaceuticals Ltd, ASX/SEC announcements 2007; summarised in FDA PCAC briefing document, December 2024 · Source

Phase 2b2007
Design
Randomised, double-blind, placebo-controlled (results announced by the company; never published in a peer-reviewed journal)
Population
Adults aged 18–65 with obesity (BMI 30–45) on a dietitian-supervised diet and exercise programme
Participants
n = 536
Duration
24 weeks
Route
Oral
Doses studied
0.25, 0.5 or 1 mg orally once daily (502 randomised)
Outcome at this exposure
No statistically significant difference in weight loss versus placebo at the 12-week primary endpoint or at 24 weeks; the company terminated development for obesity in February 2007.
Adverse events observed
The company reported no difference from placebo in safety or tolerability; full adverse-event data were never published.

Human data are limited to oral and intravenous dosing in sponsor trials that ended in 2007. There are no human studies of the subcutaneous injections or transdermal products now sold, no published pharmacokinetic data for any route, and no human data for joint or cartilage uses.

05 Safety

Adverse effects and contraindications

Common effects seen in trials or reports, serious effects that warrant urgent review, and conditions under which use is not appropriate or needs assessment.

Common adverse effects

  • Headache
  • Diarrhoea
  • Flatulence
  • Fatigue
  • Dizziness
  • Injection-site reactions (unregulated injectable products; not studied in trials)

Serious adverse effects

  • Severe chest tightness judged possibly related to intravenous dosing in an early trial
  • Immune or allergic reactions from aggregated or impure peptide (FDA concern; injectables never tested in humans)
  • Infection or contamination from non-sterile, unregulated vials
  • Unknown long-term effects — animal signals for bone and liver toxicity and equivocal genotoxicity
  • Anti-doping violation (prohibited at all times under WADA S2)

Contraindications

  • CancerCaution

    Not studied in people with cancer; several malignancies occurred in the 12-week trial (judged unrelated by investigators) and the FDA's review noted equivocal genotoxicity signals in laboratory assays.

  • Liver diseaseCaution

    Signals suggestive of liver toxicity were seen in monkeys dosed orally for nine months (FDA review); there are no human liver-safety data beyond 24 weeks.

  • DiabetesCaution

    Short trials found no effect on glucose tolerance or insulin, but people with diabetes were not the study population and no interaction data exist.

  • Hormonal disorderCaution

    Derived from growth hormone and marketed as a growth-hormone-related peptide; people with pituitary or other endocrine disorders should not assume it is inert.

  • Current or previous eating disorderCaution

    Products marketed for fat loss require specialist assessment where there is a current or previous eating disorder.

Do not use = should not be used · Caution = needs assessment

06 Interactions

Medicine classes that need review

Grouped by how seriously the combination should be taken. Class labels match the medicines questionnaire in the assessment.

  • Major
  • Moderate
  • Minor

Moderate

Monitoring or dose review is usually advised.

  • Growth hormone

    Somatropin

    Both derive from growth hormone; no interaction studies exist and combined effects are unknown.

Minor

Generally compatible; awareness is sufficient.

  • GLP-1 / incretin medicine

    Ozempic, Wegovy, Mounjaro, Saxenda

    No data on combining with incretin medicines; adding an unproven compound to an authorised weight-management medicine has no evidence base.

  • Insulin

    Lantus, NovoRapid, Humalog, Tresiba

    Trials found no effect on glucose or insulin in people without diabetes; no data in insulin users.

  • Other glucose-lowering medicine

    Metformin, SGLT2 inhibitors, DPP-4 inhibitors

    No interaction data.

07 Pregnancy & breastfeeding

Status in pregnancy

Insufficient data

No human data in pregnancy or breastfeeding; the FDA's review noted equivocal genotoxicity signals in laboratory assays. Avoidance is the only evidence-consistent position.

08 Monitoring

What is usually monitored

Parameters that trials and product information track. A clinician decides what applies to an individual.

  1. 01There is no evidence base to guide monitoring; a clinician cannot set expected effects because trials showed none
  2. 02Weight and body-fat trend against a realistic expectation of no benefit
  3. 03Liver function (animal toxicity signal; no long-term human data)
  4. 04Blood glucose if diabetic or on glucose-lowering medicines
  5. 05Injection-site reactions, rashes or other signs of an immune response
  6. 06Anti-doping status for anyone subject to testing

09 Combinations

What is known about combining it

Notes on pairing with other compounds in the directory: whether the combination has been studied in people, and where mechanisms overlap.

  • Semaglutide

    No human studies

    No human data on this combination; AOD-9604 adds no demonstrated benefit to an authorised weight-management medicine.

  • Tirzepatide

    No human studies

    No human data on this combination; AOD-9604 adds no demonstrated benefit to an authorised weight-management medicine.

  • CJC-1295

    No human studies

    Overlap · Both are marketed as growth-hormone-related fat-loss peptides.

    No human studies of the combination; neither is authorised.

  • Ipamorelin

    No human studies

    Overlap · Both are marketed as growth-hormone-related fat-loss peptides.

    No human studies of the combination; neither is authorised.

  • Tesamorelin

    No human studies

    Overlap · Both act on or derive from the growth-hormone axis.

    Tesamorelin is an authorised GHRH analogue for HIV-associated abdominal fat; adding AOD-9604 has no data.

  • BPC-157

    No human studies

    A common vendor 'stack' with no human data for either compound in combination.

  • MOTS-c

    No human studies

    A common vendor 'stack' with no human data for either compound in combination.

Discuss any proposed combination with a qualified healthcare professional.

10 Source considerations

Supply, quality and legitimacy

How the compound reaches people in practice, and what that means for product quality.

  1. 01Not authorised anywhere — every product is unregulated, with no assurance of identity, purity, sterility or dose; the FDA found inconsistencies in the sequence and structure published by some suppliers.
  2. 02In the US, the FDA's advisory committee voted against permitting AOD-9604 in compounded medicines, so clinic or 'med-spa' injections are not a regulated pathway.
  3. 03Prohibited at all times under the WADA Prohibited List (S2, growth hormone fragments); tested athletes risk a sanction.
  4. 04Sellers label vials 'for research use only' or 'not for human consumption' to avoid medicines law; this is a signal of the absence of oversight, not of quality.

11 Questions for your clinician

Take these to your appointment

Specific to this compound. The personal assessment adds questions drawn from your own history and medicines.

  1. 01Given that the 24-week trial in 536 people showed no significant weight loss, what evidence supports this for my goal?
  2. 02Which authorised options for fat loss or weight management would be appropriate for me instead?
  3. 03If I have already used it, should liver function or other tests be checked?
  4. 04Am I subject to anti-doping rules, and how long could it be detectable?
  5. 05What are the legal implications of importing or possessing it in my country?

The personal assessment tailors this list to your responses.

12 Alternatives

Compounds with stronger evidence or firmer regulatory footing

Listed for overlapping goals. Whether any is appropriate depends on your history — the assessment maps that for you.

13 References

Sources behind this record

Regulator documents and peer-reviewed publications used to derive every grade and statement above.

  1. 01Stier H, Vos E, Kenley D. Safety and tolerability of AOD9604 in humans. J Endocrinol Metab 2013
  2. 02FDA — Evaluation of AOD-9604 for the 503A bulks list (PCAC briefing document, December 2024)
  3. 03FDA — Bulk drug substances that may present significant safety risks (Category 2)
  4. 04WADA Prohibited List (S2 — peptide hormones, growth factors, related substances and mimetics)
  5. 05Heffernan MA et al. Fat oxidation and weight loss in obese mice with hGH or a C-terminal fragment. Int J Obes 2001

The Peptide Checkup provides educational information and a structured summary of published research and regulatory status. It is not medical advice, does not diagnose or treat any condition, and does not replace a consultation with a qualified healthcare professional.

Personal assessment

Check AOD-9604 against your history

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