AOD-9604 (HGH fragment 176-191): what six trials in 900 people found, why development stopped, and where it stands now
What 25 indexed publications and 0 randomized trials actually state about aod-9604, sentence by sentence, each tied to its source and labeled by the kind of evidence it is.
At a glance
What AOD-9604 is, and what the six trials found
AOD-9604 is a peptide in the metabolic other class (hGH(176-191) fragment; lipolytic activity claimed, GH-receptor independent). Europe PMC indexes 25 publications naming it or a listed alias in a title or abstract, including 0 randomized controlled trials and 0 clinical trials of any design, as of . The strongest evidence tier in that literature is animal studies only, with no indexed human study.
This page reports what those studies state, sentence by sentence, with each statement tied to its source and labeled by the kind of evidence it is. It does not recommend use, and it does not translate study doses into anything personal.
What the evidence level means
Publication counts show what is indexed, not how strong the evidence is. The ledger below separates human clinical records from preclinical, analytical, and in-vitro work.
Interpretation boundary: An indexed publication count is a discovery measure. It does not establish efficacy, safety, approval, or a personal treatment plan.
AOD-9604 in two minutes
What it is. The fat-mobilising tail of human growth hormone, residues 177 to 191 plus a stabilising tyrosine, designed at Monash University so that the fat effect could be had without growth hormone's effects on IGF-1, blood sugar and growth. Also sold as 'HGH fragment 176-191'.
What the research actually shows. Six randomized placebo-controlled trials in 893 adults between 2001 and 2006, pooled in one sponsor paper: safety and tolerability indistinguishable from placebo, no IGF-1 rise, no effect on glucose tolerance, no antibodies. The two trials built to show weight loss, 300 people for 12 weeks and 502 people for 24 weeks on oral capsules and tablets, did not beat placebo, and the sponsor stopped in 2007.
The catch for the product people buy. Every trial gave it by mouth or by intravenous infusion. No trial has injected it under the skin, which is the only way it is sold.
Status. Not approved as a drug. GRAS as a food ingredient since 2014, which is not approval. Listed by WADA under S2. On and then off FDA's compounding category 2 list (2023 to 2024). Being redeveloped as LAT8881 for pain.
Where the evidence is thinnest. Efficacy by any route, and anything at all by the injected route.
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
How it works
Written from general pharmacology and the development record, and marked as editorial synthesis; the measurements behind it are quoted in the biomarker section.
- Editorial synthesis from general knowledge
- Editorial synthesis from general knowledge
- Editorial synthesis from general knowledge
What happened in the human studies?
This record's ledger holds 3 primary human studies, of which 3 are trials. Few enough to show in full: each card quotes what its abstract reported about AOD-9604. Read them before any other section on this page.
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Between 2001 and 2006 six human clinical trials with the hexadecapeptide AOD9604 have been performed, 893 healthy, in all but one study, clinically obese adults participated in these studies and are the basis of this safety evaluation.
Sourcedoi-10-4021-jem157w· quoted verbatim from the abstract -
METAOD006: A Phase IIb, randomized, double-blind, placebo-controlled study to assess the efficacy (reduction in body weight), safety and tolerability of 24 weeks treatment with different doses of AOD9604 tablets (0.25 mg, 0.5 mg, 1 mg, or placebo) in 502 obese adults.
Sourcedoi-10-4021-jem157w· quoted verbatim from the abstract -
METAOD005: A Phase IIb (randomized, double-blind, placebo-controlled) study to assess the efficacy (reduction in body weight), safety and tolerability of 12 weeks treatment with daily doses (1, 5, 10, 20 or 30 mg AOD9604) administered orally (capsules) in 300 healthy, clinically obese males, and females of non-child bearing potential, with a BMI ≥ 35 kg/m 2 .
Sourcedoi-10-4021-jem157w· quoted verbatim from the abstract
Trial by trial: what AOD-9604 did, and did not do, in people
The six trials from the sponsor's 2013 safety paper, which is their only published account, plus the animal studies that motivated them.
| Trial | Participants | Route and dose | Duration | Result |
|---|---|---|---|---|
| METAOD001 | 15 healthy men | IV infusion over 20 min, 25 to 400 mcg/kg; growth hormone as positive control | Three single doses, 7-day washouts | 29 mild adverse events, mostly headache, spread evenly across doses and placebo; no IGF-1 or glucose change |
| METAOD002 | 23 obese men, BMI 36 to 67 | IV infusion, 25, 50 or 100 mcg/kg | Four single doses, 7-day washouts | Headache in 70%; one severe chest tightness possibly related; euphoria in 5 of 23 on drug, none on placebo |
| METAOD003 | 17 obese men | Oral capsules, 9, 27 or 54 mg | Single doses | No treatment-related adverse events |
| METAOD004 | 36 obese men | Oral capsules, 9, 27 or 54 mg daily | 7 days | Well tolerated; more gastrointestinal events at 54 mg |
| METAOD005 (phase 2b) | 300 obese adults, BMI 35 or more | Oral capsules, 1, 5, 10, 20 or 30 mg daily | 12 weeks | Efficacy endpoint (weight) not met per the sponsor's later decision; five cancers as serious adverse events, judged unrelated, none at the top dose |
| METAOD006 (phase 2b) | 502 obese adults | Oral tablets, 0.25, 0.5 or 1 mg daily | 24 weeks, after 4-week run-in, with 30-day follow-up | Efficacy endpoint (weight) not met; safety indistinguishable from placebo; development stopped February 2007 |
| Study | Model | Route and dose | Duration | Result |
|---|---|---|---|---|
| Ng 2000 | Obese Zucker rats | Oral, 500 mcg/kg daily | 19 days | Weight gain cut by more than half; fat-tissue lipolysis up; insulin sensitivity unchanged |
| Heffernan 2001 | Obese mice; beta-3 receptor knockout mice | Intraperitoneal, chronic | 14 days | Weight and fat down with restored beta-3 receptor expression; no effect in knockout mice |
| Kwon 2015 | 32 rabbits with collagenase knee arthritis | Intra-articular, 0.25 mg weekly, with or without hyaluronic acid | 4 to 7 weeks | Less cartilage degeneration; shortest lameness with the combination |
The two phase 2b results were never published as papers. What exists is the sponsor's statement that they did not meet their weight endpoints, its decision to stop, and the pooled safety paper. The FDA advisory committee that reviewed the compound in December 2024 worked from the same six trials.
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
What the evidence shows
One row per primary study in this record's ledger. Fields are read from each paper's indexing and abstract. "Analytical method" marks papers about detecting or measuring the compound rather than about its effects.
| Study | Design | n | Species | Dose | Route | Duration | Reported outcome | Tier |
|---|---|---|---|---|---|---|---|---|
| Stier 2013 | Pooled safety analysis of six randomized placebo-controlled trials | 893 | Humans | 25 to 400 mcg/kg IV; 0.25 to 54 mg/day oral | intravenous; oral | single dose to 24 weeks | Between 2001 and 2006 six human clinical trials with the hexadecapeptide AOD9604 have been performed, 893 healthy, in all but one study, clinically obese adults participated in these studies and are the basis of this safety evaluation. | Human clinical trial |
| Stier 2013 (METAOD006) | Randomized controlled trial, phase 2b | 502 | Humans | 0.25, 0.5 or 1 mg/day oral tablets | oral | 24 weeks | METAOD006: A Phase IIb, randomized, double-blind, placebo-controlled study to assess the efficacy (reduction in body weight), safety and tolerability of 24 weeks treatment with different doses of AOD9604 tablets (0.25 mg, 0.5 mg, 1 mg, or placebo) in 502 obese adults. | Human clinical trial |
| Stier 2013 (METAOD005) | Randomized controlled trial, phase 2b | 300 | Humans | 1, 5, 10, 20 or 30 mg/day oral capsules | oral | 12 weeks | METAOD005: A Phase IIb (randomized, double-blind, placebo-controlled) study to assess the efficacy (reduction in body weight), safety and tolerability of 12 weeks treatment with daily doses (1, 5, 10, 20 or 30 mg AOD9604) administered orally (capsules) in 300 healthy, clinically obese males, and females of non-child bearing potential, with a BMI ≥ 35 kg/m 2 . | Human clinical trial |
| Kwon 2015 | Animal study | 32 | Rabbits | — | — | 7 weeks | Mean gross morphological and histopathological scores were significantly higher in Group 1 than in Groups 2, 3, and 4, and the scores were significantly lower in Group 4 than in Groups 2 and 3. | Animal, preclinical |
| Heffernan 2001 | Animal study | — | Mice | — | intraperitoneal | — | Importantly, both hGH and AOD9604 are capable of increasing the repressed levels of beta(3)-AR RNA in obese mice to levels comparable with those in lean mice. | Animal, preclinical |
| Ng 2000 | Animal study | — | Rats | — | oral | 19 days | The adipose tissues of the AOD9604--treated animals were found to have an increase in lipolytic activity. | Animal, preclinical |
| Mazzarino 2026 | Analytical method | — | Humans | — | — | — | Stability studies showed that all compounds were stable (variation lower than 15%) for at least two months at -20 °C in all the blood matrices considered. | Mechanistic, in vitro |
| Habibullah 2022 | In vitro study | — | Humans | — | — | — | These dual-loaded Chitosan nanoparticles demonstrated greater anti-proliferative activity against a breast cancer cell line (MCF-7) than doxorubicin-loaded Chitosan. | Mechanistic, in vitro |
| Thomas 2016 | Analytical method | — | Humans | — | — | — | — | Mechanistic, in vitro |
| Bayés 2003 | In vitro study | — | Humans | — | inhaled, oral | — | — | Mechanistic, in vitro |
Doses reported in studies
Each entry is a sentence quoted from the study's abstract, with the study's design, sample size and year in front of it. Comparator doses in the same sentence are not attributed to aod-9604.
- Source
doi-10-4021-jem157w - Source
doi-10-4021-jem157w - Source
doi-10-4021-jem157w - Source
doi-10-4021-jem157w - Source
pmid-11146367 - Source
pmid-26275694
Every AOD-9604 dose in the trials and studies, in one table
Every figure here was given in a trial or study. The subcutaneous microgram figures on vendor pages were never given to a person in any trial.
| Setting | Route | Dose | Schedule | Population |
|---|---|---|---|---|
| Phase 1 and 2a (2001 to 2003) | Intravenous infusion | 25 to 400 mcg/kg | Single doses | Healthy and obese men |
| Phase 2a (2003 to 2004) | Oral capsules | 9, 27, 54 mg | Single; then daily for 7 days | Obese men |
| Phase 2b METAOD005 | Oral capsules | 1, 5, 10, 20, 30 mg | Daily, 12 weeks | 300 obese adults |
| Phase 2b METAOD006 | Oral tablets | 0.25, 0.5, 1 mg | Daily, 24 weeks | 502 obese adults |
| Rats | Oral gavage | 500 mcg/kg | Daily, 19 days | Obese Zucker rats |
| Mice | Intraperitoneal | Not stated in the abstract | Daily, 14 days | Obese and beta-3 knockout mice |
| Rabbits | Intra-articular (into the knee) | 0.25 mg, with or without 6 mg hyaluronic acid | Weekly, 4 to 7 weeks | Collagenase arthritis model |
Figures for injected AOD-9604 circulate on forums and vendor pages. None was given to a person in any trial, so none is reproduced here; the table holds every dose a study actually administered. Note the scale: the oral doses that failed to beat placebo ran to 54 mg, and the vendor figures are a fraction of a milligram by a route nobody has tested.
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
Side effects: the unusual case of a peptide with real safety data
From six placebo-controlled trials pooled by the sponsor: tolerability indistinguishable from placebo, no IGF-1 rise, no effect on glucose tolerance, no antibodies. The one thing the trials did not show is that it works. Events and their frequency as each study reported them, with the denominator where the abstract gives one.
- Source
doi-10-4021-jem157w - Source
doi-10-4021-jem157w - Source
doi-10-4021-jem157w - Source
doi-10-4021-jem157w - Source
doi-10-4021-jem157w - Source
pmid-11146367 - Editorial synthesis from general knowledge · primary document to be added to the ledger
Who AOD-9604 is discussed for, and the cautions that recur
Studied: healthy and obese adults, mostly men, for up to 24 weeks by mouth or intravenously. Excluded or unstudied: anyone by subcutaneous injection; children; pregnancy; people with diabetes or cancer history (the trials enrolled 'otherwise healthy' obese adults). Community: people seeking fat loss without GLP-1 drugs, and people with joint pain who have read about the rabbit study.
The cautions here are unusual for a research peptide, because there is real safety data, and they follow from it:
- Expecting it to work. Two placebo-controlled trials in 800 people did not show weight loss. That is the strongest evidence on this page, and it is negative.
- The injected route. Safety data are for oral and intravenous dosing. Subcutaneous injection of an unregulated product has no data behind it, good or bad.
- Cancer history. The 12-week trial recorded five cancers as serious adverse events, judged unrelated by the investigator, with reasons given. IGF-1 did not rise. It remains the one signal in the record, and anyone with a cancer history should know it exists.
- Euphoria. Reported by 5 of 23 obese men during intravenous dosing and by none on placebo, in one small study.
- Gastrointestinal effects at high oral doses. Seen at 54 mg, not below 27 mg.
- Tested athletes. Named on the WADA Prohibited List under S2, prohibited at all times; detection methods exist.
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
Biomarkers measured in studies
Laboratory and clinical measures the studies report tracking, including which hormones did and did not change.
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Both human GH (hGH) and a lipolytic fragment (AOD9604) synthesized from its C-terminus are capable of inducing weight loss and increasing lipolytic sensitivity following long-term treatment in mice.
Sourcepmid-11713213· quoted verbatim from the abstract -
A synthetic analogue (AOD9604) of the lipolytic domain of human growth hormone (hGH) has been studied for its metabolic actions in obese Zucker rats.
Sourcepmid-11146367· quoted verbatim from the abstract -
To evaluate the anticancer efficacy of Chitosan nanoparticles loaded with human growth hormone hGH fragment 176-191 peptide plus the clinical chemotherapeutic doxorubicin in comparison with Chitosan loaded with doxorubicin alone.
Sourcepmid-35783198· quoted verbatim from the abstract -
This issue focuses on the following selection of drugs: Abetimus sodium, adefovir dipivoxil, AGI-1067, alefacept, alemtuzumab, ALVAC-p53, aminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, Anti-CTLA-4 Mab, AOD-9604, apafant, aprinocarsen sodium, arsenic trioxide; Balaglitazone, BIM-23190, bimatoprost, bortezomib, bosentan, BR-1; Canertinib dihydrochloride, CDP-850, cevimeline hydrochloride, cinacalcet hydrochloride, clenoliximab, clevudine, CN-787; D-003, darusentan, deferasirox, desloratadine dexanabinol, duloxetine hydrochloride; E-5564, edaravone, efaproxiral sodium, elvucitabine emfilermin, EN-101, enfuvirtide, entecavir, epithalon, eplerenone, erlotinib hydrochloride, escitalopram oxalate, esomeprazole magnesium, eszopiclone, etilefrine pivalate hydrochloride etoricoxib, everolimus, exenatide; Fidarestat, fondaparinux sodium; Ganstigmine hydrochloride; Homoharringtonine, HuMax-IL-15, hyperimmune IVIG; Imatinib mesylate, IMC-1C11, Inhaled insulin, irofulven, iseganan hydrochloride, ISIS-14803, ISIS-5132, ivabradine hydrochloride; Keratinocyte growth factor; Lafutidine, lanthanum carbonate, LAS-34475, levocetirizine, liraglutide, LY-307161 SR; Magnesium sulfate, maribavir, melatonin, mycobacterium cell wall complex; NN-414, NO-aspirin, nociceptin, nolomirole hydrochloride; Olmesartan medoxomil oral insulin, ospemifene; PDX, perillyl alcohol, pimecrolimus, pitavastatin calcium, pramlintide acetate, prasterone, pregabalin, PRO-542, PV-701, pyrazoloacridine; R-744, ranelic acid distrontium salt, rasburicase, rDNA insulin, resiniferatoxin, reslizumab, ridogrel, riplizumab ropivacaine, rosuvastatin calcium, roxifiban acetate, ruboxistaurin mesilate hydrate; Satraplatin, Sch-58500, semaxanib, sitaxsentan sodium, SMP-114, SU-6668; Teriparatide, tetrathiomolybdate, tipifarnib, tolvaptan, travoprost, treprostinil sodium; Valdecoxib, valganciclovir hydrochloride, vardenafil hydrochloride hydrate, vatalanib succinate; Ximelagatran; Z-335, ziprasidone hydrochloride, zoledronic acid monohydrate, ZYC-00101.
Sourcepmid-14571286· quoted verbatim from the abstract
Reported timelines
Onset, peak and duration figures as each study reported them.
- Source
pmid-42328738
What is measured over time, and what is not
The human record runs from single doses to 24 weeks, the longest exposure of any research peptide on this site, with a 30-day follow-up in the last trial. Over that time safety measures stayed level with placebo, and so did weight. Nothing was measured beyond 24 weeks, and nothing at all was measured after subcutaneous injection, so the community's eight-to-twelve-week cycles have no time course behind them. A 2026 doping-control study adds that the peptide degrades within a week in liquid blood samples at fridge and room temperature, a laboratory stability finding rather than a pharmacokinetic one; no human half-life is stated in any abstract in the ledger.
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
Study durations
Treatment and follow-up periods as stated in each abstract.
- Source
doi-10-4021-jem157w - Durations stated: 7 weeks
Weekly injections of 0.6 mL saline (Group 1), 6 mg HA (Group 2), 0.25 mg AOD9604 (Group 3), and 0.25 mg AOD9604 with 6 mg HA (Group 4) were administered for 4-7 weeks after the first intra-articular collagenase injection.
Sourcepmid-26275694· quoted verbatim from the abstract, emphasis added - Durations stated: 19 days
Daily treatment with an oral dose of AOD9604 of 500 microg/kg body weight for 19 days reduced over 50% (15.8 +/- 0.6 vs. 35.6 +/- 0.8 g) body weight gain of the animals in comparison with the control.
Sourcepmid-11146367· quoted verbatim from the abstract, emphasis added
Routes: oral capsules and intravenous infusion in the trials, injection only on vendor pages
Intravenous in the first two trials, oral capsules or tablets in the last four, oral gavage or intraperitoneal in rodents, and intra-articular in rabbits. No trial gave AOD-9604 by subcutaneous injection, the only route it is sold for. Routes of administration named in each study.
- administration by intraperitoneal route reported
Here we describe how hGH and AOD9604 can reduce body weight and body fat in obese mice following 14 d of chronic ip administration.
Sourcepmid-11713213· quoted verbatim from the abstract - administration by oral route reported
Daily treatment with an oral dose of AOD9604 of 500 microg/kg body weight for 19 days reduced over 50% (15.8 +/- 0.6 vs. 35.6 +/- 0.8 g) body weight gain of the animals in comparison with the control.
Sourcepmid-11146367· quoted verbatim from the abstract - administration by inhaled, oral route reported
This issue focuses on the following selection of drugs: Abetimus sodium, adefovir dipivoxil, AGI-1067, alefacept, alemtuzumab, ALVAC-p53, aminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, Anti-CTLA-4 Mab, AOD-9604, apafant, aprinocarsen sodium, arsenic trioxide; Balaglitazone, BIM-23190, bimatoprost, bortezomib, bosentan, BR-1; Canertinib dihydrochloride, CDP-850, cevimeline hydrochloride, cinacalcet hydrochloride, clenoliximab, clevudine, CN-787; D-003, darusentan, deferasirox, desloratadine dexanabinol, duloxetine hydrochloride; E-5564, edaravone, efaproxiral sodium, elvucitabine emfilermin, EN-101, enfuvirtide, entecavir, epithalon, eplerenone, erlotinib hydrochloride, escitalopram oxalate, esomeprazole magnesium, eszopiclone, etilefrine pivalate hydrochloride etoricoxib, everolimus, exenatide; Fidarestat, fondaparinux sodium; Ganstigmine hydrochloride; Homoharringtonine, HuMax-IL-15, hyperimmune IVIG; Imatinib mesylate, IMC-1C11, Inhaled insulin, irofulven, iseganan hydrochloride, ISIS-14803, ISIS-5132, ivabradine hydrochloride; Keratinocyte growth factor; Lafutidine, lanthanum carbonate, LAS-34475, levocetirizine, liraglutide, LY-307161 SR; Magnesium sulfate, maribavir, melatonin, mycobacterium cell wall complex; NN-414, NO-aspirin, nociceptin, nolomirole hydrochloride; Olmesartan medoxomil oral insulin, ospemifene; PDX, perillyl alcohol, pimecrolimus, pitavastatin calcium, pramlintide acetate, prasterone, pregabalin, PRO-542, PV-701, pyrazoloacridine; R-744, ranelic acid distrontium salt, rasburicase, rDNA insulin, resiniferatoxin, reslizumab, ridogrel, riplizumab ropivacaine, rosuvastatin calcium, roxifiban acetate, ruboxistaurin mesilate hydrate; Satraplatin, Sch-58500, semaxanib, sitaxsentan sodium, SMP-114, SU-6668; Teriparatide, tetrathiomolybdate, tipifarnib, tolvaptan, travoprost, treprostinil sodium; Valdecoxib, valganciclovir hydrochloride, vardenafil hydrochloride hydrate, vatalanib succinate; Ximelagatran; Z-335, ziprasidone hydrochloride, zoledronic acid monohydrate, ZYC-00101.
Sourcepmid-14571286· quoted verbatim from the abstract
Weight-normalized doses, as published
Per-kilogram figures exactly as each study published them, for the species it studied.
- Source
doi-10-4021-jem157w - Source
pmid-11146367
Weight-normalized figures above are reproduced exactly as each study published them, for the species it studied. Dose does not scale linearly with body mass between species: metabolic rate, clearance and receptor density differ, and regulatory guidance uses allometric, not proportional, conversion. A mg/kg figure from a rat study is a fact about that rat study and nothing else.
What people report outside the literature
Forum reports describe modest fat loss, no effect, and stacking with other peptides. The injectable use has no trial behind it; the trials that exist were oral and found nothing against placebo. What circulates in user communities and clinic marketing, reported so a reader knows the figures and their origin. None of it has been tested in a trial, and none of it is a suggestion.
- Editorial synthesis from general knowledge
Reconstitution mathematics
Lyophilised peptide is supplied as a mass in a vial and dissolved in a stated volume of diluent. Two figures follow from that and nothing else:
- Concentration = mass in vial ÷ diluent volume. A 5 mg vial in 2 mL is 2.5 mg/mL, or 2,500 mcg/mL.
- Volume for a given mass = that mass ÷ concentration. 250 mcg at 2,500 mcg/mL is 0.1 mL. On a U-100 insulin syringe, where 1 mL is 100 units, that is 10 units.
Study doses on this page are quoted as published, in the units the authors used. Converting between mcg, mg and IU, or between a mass and a syringe volume, is arithmetic; deciding a mass is not, and this page does not do it. The reconstitution calculator performs the conversion with the formula shown.
Reading a certificate of analysis
A certificate of analysis is a laboratory report on one batch. Reading it means checking four things in order.
- Identity. Mass spectrometry should report an observed molecular mass matching the peptide's theoretical mass within the instrument's stated tolerance. A certificate with no mass spectrometry, or one that lists only the expected value, has not confirmed identity.
- Purity. HPLC purity is the area of the main peak as a share of all peaks, at a stated wavelength. It says nothing about what the other peaks are, and it is not a measure of quantity.
- Quantity. Net peptide content, by amino acid analysis or UV, is the fraction of the vial's mass that is peptide rather than counter-ions and water. A 5 mg vial at 80% net content holds 4 mg of peptide, and every concentration figure above changes accordingly.
- Provenance. The batch number on the certificate should match the vial, the laboratory should be named and independent of the seller, and the test date should be recent.
This page rates no supplier and links to none. It describes how to read the document.
Equipment described in studies
Published human studies of injectable peptides report the same small set of materials: single-use insulin syringes with fixed needles, most often U-100 with 29 to 31 gauge needles; bacteriostatic water or sterile water for injection as diluent, with the choice stated in the methods; alcohol swabs; and refrigerated storage of reconstituted solution. Animal studies more often report intraperitoneal or intragastric administration and state the vehicle used. Where a study in this record's ledger names its materials or vehicle, that sentence appears under storage or routes above; where it does not, nothing is assumed here.
Storage and handling
The trial product was lyophilised powder reconstituted with sterile water for intravenous use, or capsules and tablets; the 2026 anti-doping study found the peptide degraded within a week in liquid serum and plasma above freezing, while stable for two months at minus 20 degrees. Vendor vials follow general lyophilised-peptide practice; their contents are unverified.
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
Common mistakes in how AOD-9604 is discussed
- Reading GRAS as FDA approval. GRAS is a food-ingredient safety designation self-affirmed by an industry panel in 2014. It is not a drug approval and says nothing about fat loss.
- Treating the safety data as efficacy data. Six trials show it is as safe as placebo. The two efficacy trials show it is as effective as placebo. Both facts come from the same programme.
- Assuming injection succeeds where oral failed. A reasonable hypothesis with no trial behind it. The first two trials were intravenous and measured safety, not weight.
- Quoting 250 to 500 mcg as a clinical dose. No trial gave that dose by that route. The oral trials ran to 54 mg.
- Calling the compounding history an endorsement. Category 2 listing (2023) meant FDA saw safety concerns; removal (2024) meant the nominators withdrew, not that FDA cleared it; the December 2024 committee review worked from the same failed programme.
- Missing where the molecule actually went. Its current development, as LAT8881, is for neuropathic pain and osteoarthritis, not fat loss.
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
AOD-9604 vs tesamorelin, semaglutide, tirzepatide and growth hormone
| Agent | What it is | Fat or weight evidence | Status |
|---|---|---|---|
| AOD-9604 | Growth hormone fragment 177-191 | Two phase 2b trials (800 people, oral) did not beat placebo | Not approved; GRAS food ingredient; WADA S2 |
| Tesamorelin | Stabilised GHRH analogue that raises the body's own growth hormone; 115 indexed publications, 22 randomized trials | Reduces visceral fat in HIV-associated lipodystrophy in phase 3 trials | Approved 2010; WADA S2 |
| Semaglutide | GLP-1 receptor agonist; 6039 indexed publications, 305 randomized trials | About 15% weight loss at 68 weeks; cardiovascular outcomes trial | Approved 2017 |
| Tirzepatide | GIP/GLP-1 agonist; 2756 indexed publications, 131 randomized trials | About 15 to 21% weight loss at 72 weeks | Approved 2022 |
| Growth hormone (somatropin) | The full 191-amino-acid hormone AOD-9604 was cut from | Reduces fat and raises lean mass in deficiency; raises IGF-1 and blood sugar | Prescription medicine; WADA S2 |
| Tesofensine | Oral triple reuptake inhibitor in this site's 'metabolic, other' class; 63 indexed publications | About 9 to 10% at 24 weeks in phase 2; heart-rate signal | Not approved; Mexican application pending |
The question people ask, 'tesamorelin or AOD-9604', has a plain answer in the records: tesamorelin has an approval and phase 3 fat-loss data; AOD-9604 has a phase 2b programme that failed. No study has compared them, and none is likely to.
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
Other compounds in its class
Same class in the registry: SLU-PP-332, Tesofensine. Each row shows what that compound's own record states; nothing is inferred across rows.
| Compound | Tier | Publications | RCTs | Record |
|---|---|---|---|---|
| AOD-9604 | Human clinical trial | 25 | 0 | draft |
| SLU-PP-332 | Observational, human | 12 | 0 | draft |
| Tesofensine | Human clinical trial | 63 | 12 | draft |
Regulatory status: GRAS as a food ingredient, not approved as a drug, a moving compounding position
Registry facts only. Jurisdiction-level status, compounding categories and sport prohibitions need their own cited documents before they appear here.
- Editorial synthesis from general knowledge · primary document to be added to the ledger
Open questions and limitations
What is genuinely unknown, stated plainly. A missing field is not evidence that the outcome is safe, effective, or established.
- The two phase 2b trials (300 and 502 participants) were never published; their efficacy results exist only as the sponsor's statement that endpoints were not met and its 2007 decision to stop.
- No trial has given AOD-9604 by subcutaneous injection, the only route it is sold for.
- FDA's 2023 and 2024 compounding notices, the December 2024 advisory committee briefing and the 2014 GRAS notice are not yet in the ledger.
Questions people ask
What is AOD-9604?
AOD-9604 is a synthetic 16-amino-acid fragment of human growth hormone, residues 177 to 191 with a tyrosine added at the front, designed at Monash University in the 1990s to keep growth hormone's fat-mobilising action without its effects on IGF-1, blood sugar and growth. Metabolic Pharmaceuticals took it through six trials in about 900 obese adults, mostly as oral capsules, and stopped in 2007 when it did not beat placebo for weight loss. It is now sold as an injectable research chemical and, as LAT8881, is being redeveloped for pain.
What is the half-life of AOD-9604?
No abstract in the ledger states a human half-life. Peptides of this size are cleared in minutes to an hour, and a 2026 anti-doping study found AOD-9604 extensively degraded within a week in serum at room and fridge temperatures, which speaks to sample stability rather than to time in the body. The oral trials dosed once daily; nothing about the injected route's kinetics has been published.
Does AOD-9604 repair cartilage?
In one rabbit study, weekly intra-articular injections of 0.25 mg AOD-9604, especially with hyaluronic acid, reduced cartilage degeneration scores and shortened lameness after collagenase-induced knee arthritis. No human joint study exists; its successor LAT8881 is being developed for pain, not cartilage. The rabbit study was a joint injection, not a subcutaneous one.
Does AOD-9604 work for weight loss?
Not in the trials designed to find out. Two randomized placebo-controlled phase 2b trials, 300 people for 12 weeks on 1 to 30 mg capsules and 502 people for 24 weeks on 0.25 to 1 mg tablets, did not show weight loss beyond placebo, and the sponsor stopped development in February 2007. The results were never published individually; the sponsor's 2013 safety paper and its own decision are the record.
Is AOD-9604 safe?
By the standards of research peptides, unusually well documented: six placebo-controlled trials in 893 adults found tolerability indistinguishable from placebo, no rise in IGF-1, no effect on glucose tolerance and no antibodies. The caveats are that every trial dosed by mouth or intravenously, not by subcutaneous injection, and that five cancers occurred in the 12-week trial, judged unrelated.
Is AOD-9604 FDA approved?
No. It has never been approved as a drug anywhere. In 2014 an industry panel self-affirmed it as GRAS for use as a food ingredient, which is a safety designation for food, not a drug approval and not a finding about fat loss. Its compounding status has moved: category 2 in September 2023, removed in September 2024, reviewed by an advisory committee in December 2024.
What dose was used in the trials?
Intravenous infusions of 25 to 400 micrograms per kilogram in the first two trials; oral capsules of 9, 27 and 54 mg in the phase 2a studies; 1 to 30 mg capsules daily for 12 weeks and 0.25 to 1 mg tablets daily for 24 weeks in the phase 2b trials. No trial gave it by subcutaneous injection at any dose.
What are the side effects of AOD-9604?
In the trials, none that separated from placebo across the dose range up to 27 mg; more gastrointestinal complaints at 54 mg; headache after intravenous infusion at rates similar to placebo; euphoria in 5 of 23 obese men during intravenous dosing in one study. IGF-1 and glucose were unaffected.
Is AOD-9604 the same as HGH fragment 176-191?
Yes. 'HGH fragment 176-191' is the structural name for the same molecule, growth hormone residues 177 to 191 with a tyrosine at position 176. Vendors use both names; the trials used AOD9604.
Why did AOD-9604 work in rats but not in people?
The literature does not say. In obese rats and mice it raised fat breakdown and cut weight gain through the beta-3 adrenergic receptor, and the human trials confirmed it did not raise IGF-1 or disturb glucose. The efficacy half of the design simply did not transfer; the sponsor stopped rather than publish an explanation.
Does AOD-9604 help joints or cartilage?
In one rabbit study, weekly injections into arthritic knees of 0.25 mg, especially with hyaluronic acid, reduced cartilage degeneration and lameness. No human joint study exists. The molecule's developer now pursues it as LAT8881 for neuropathic pain and osteoarthritis, which is where its future, if any, lies.
Is AOD-9604 banned in sport?
Yes. WADA names AOD-9604 on the Prohibited List under S2 as a growth hormone fragment, prohibited at all times, and anti-doping laboratories publish detection methods for it in urine and blood.
What is LAT8881?
The same molecule under Lateral Pharma's code, after Metabolic Pharmaceuticals' obesity programme ended. Lateral is developing it as an oral treatment for neuropathic pain and osteoarthritis, on the basis of animal and in vitro work; a phase 2a trial in neuropathic pain has been registered. None of that is fat-loss evidence.
Can AOD-9604 be taken orally?
It was, in four of the six trials, as capsules and tablets up to 54 mg, and it is a GRAS food ingredient in the United States. Oral dosing is the tested route. The oral trials are also the ones that failed to show weight loss.
Which species has AOD-9604 been studied in?
Humans, in six trials totalling 893 adults; obese Zucker rats and obese and knockout mice for fat metabolism; and rabbits for knee arthritis. It also appears in doping-control method papers and in a breast-cancer cell study of nanoparticle drug delivery that used the fragment as a targeting ligand.
Sources
Full citations. Every claim above links to one of these by its id.
- 1Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans
doi-10-4021-jem157w· · peer-reviewed - 2
- 3Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance
doi-10-20944-preprints202512-1011-v3· · preprint - 4Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance
doi-10-20944-preprints202512-1011-v1· · preprint - 5
- 6
- 7Effect of Intra-articular Injection of AOD9604 with or without Hyaluronic Acid in Rabbit Osteoarthritis Model.
pmid-26275694· · peer-reviewed - 8Analytical approaches for the detection of emerging therapeutics and non-approved drugs in human doping controls.
pmid-24906629· · peer-reviewed - 9Current updates in the medical management of obesity.
pmid-22435392· · peer-reviewed - 10[Obesity: a review of currently used antiobesity drugs and new compounds in clinical development].
pmid-17971763· · peer-reviewed - 11Potential role of new therapies in modifying cardiovascular risk in overweight patients with metabolic risk factors.
pmid-16931496· · peer-reviewed - 12Obesity drugs in clinical development.
pmid-16625817· · peer-reviewed
Show the remaining 3 sources
- 13Gateways to clinical trials.
pmid-14571286· · peer-reviewed - 14
- 15Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone.
pmid-11146367· · peer-reviewed
Reference card
- Compound
- AOD-9604, metabolic other
- Evidence tier
- Human clinical trial
- Indexed publications
- 25 · 0 RCTs · 6 other clinical trials
- Approval
- not approved · max phase 2
- Routes reported
- inhaled, intraperitoneal, intravenous; oral, oral
- Reviewed
- Adam Mirando, PharmD,
Study figures are as published in each source and are not recommendations. Print or save this card with its date.
Last reviewed and what changed
Newest first. These are the record's own revision dates, and the same dates feed the sitemap.
- · Reviewed by Adam Mirando, PharmD, on 2026-09-25.
- · Label correction: 2 evidence rows built from detection and doping-control papers carried study designs such as animal or in-vitro work. They are relabelled Analytical method, the label scripts/draft_claims.py has applied since the rule was added; these rows predate it. pmid-42328738 (In vitro study -> Analytical method); pmid-26578461 (In vitro study -> Analytical method)
- · Stage 0 gap closed by hand: Stier, Vos and Kenley 2013 (the sponsor's pooled account of six trials, not indexed in Europe PMC) added to the ledger with three evidence rows; tier set to human-clinical-trial. Written under the sequencing rule after research/intents/aod-9604.json: guide (8 sections incl. a six-trial table), FAQ to 12 plus 8 from the map, dose, weight-normalized, duration, adverse-event, mechanism, reported-use and regulatory claims; misdrafted content none; intent-driven H1 and title carrying both names.
- · Claims drafted extractively from 12 ledger sources by scripts/draft_claims.py: 11 claims, 7 evidence-table rows. Status researched -> draft.
- · Claims drafted extractively from 12 ledger sources by scripts/draft_claims.py: 15 claims, 7 evidence-table rows. Status researched -> draft.
- · Claims drafted extractively from 12 ledger sources by scripts/draft_claims.py: 16 claims, 7 evidence-table rows. Status researched -> draft.
- · Metadata refreshed by scripts/fetch_evidence.py --refresh-meta: chembl None -> CHEMBL6068615.
- · Evidence fetched from Europe PMC and ChEMBL by scripts/fetch_evidence.py; claims not yet written.