AOD9604

A synthetic C-terminal growth-hormone fragment developed for obesity research.

Human trialsPeptide research profile

Also known as: AOD-9604, Tyr-hGH177-191

Dosing & scaling, explained

The 250 mcg daily calculator row is an unofficial recorded preset, not the regimen validated by the failed obesity program. This is educational source context, not a protocol or recommendation.

How sourced amounts are organized

  1. Starting pointNot clinically establishedNo validated titration window

    There is no regulator-approved starting dose for this research use. A low-looking number is not automatically safe.

  2. Recorded preset250 mcg / dayCalculator library reference

    This is the range represented in the in-app protocol library. It describes the source record; it does not validate the regimen.

  3. Higher exposureNot established for injectionRisk and uncertainty increase

    Higher exposure is not established as more effective. Human pharmacokinetic and long-term safety data may be absent.

Drug amount and device markings are different quantities. The calculator converts mass into volume, syringe units, or pen clicks.

Patterns described in source material

  • Daily in the recorded preset

    The cadence represented by the recorded calculator presets.

  • Oral doses varied across phase 2 studies

    Published experiments may use a different route, formulation, timing, or population and should not be treated as interchangeable.

  • No universal schedule

    No single schedule has been validated across products or research contexts.

Clinical context
  • 0.25-1 mgDaily oral arms24-week phase 2b studyNo significant weight-loss efficacy

Human studies tested multiple IV and oral designs; the largest obesity trial did not meet its efficacy endpoint.

Storage, handling and interpretation

Lyophilized material

Keep cold, dry, and protected from light according to the manufacturer certificate or validated lab SOP.

After reconstitution

Use sterile technique, refrigerate as validated, and avoid repeated freeze-thaw cycles.

Traceability

Record lot, concentration, preparation date, and the identity/purity documentation used by the lab.

Reported protocols for AOD-9604

What published studies and recent community write-ups report about amounts, timing and course length. 7 clinical, 2 preclinical and 4 community-reported rows, each linked to its source. These are descriptions of what others report, not instructions, and nothing here is medical advice.

ContextDoseFrequencyRouteCourseSource
Clinical7 rows
Phase 1 intravenous dose escalation (METAOD001)15 healthy adult men with a BMI between 24 and 3025 to 400 mcg/kgThree single doses plus placebo per person, each separated by a 7-day washoutIntravenous infusion over 20 minutesSingle doses only7 days between dosesJournal of Endocrinology and Metabolism2013
Twelve of 15 men reported adverse events, most commonly headache, with no serious events and no clinically significant changes in vital signs, laboratory values or ECGs. Growth hormone was given to the same men as a positive control, and no glycerol, glucose or IGF-1 trend separated AOD-9604 from placebo or from growth hormone.
Intravenous dosing in obese men (METAOD002)23 obese men aged 19 to 50 with a BMI of 35 or more25, 50 and 100 mcg/kgFour single doses per person in a Latin square design, 7 days apartIntravenous infusion over 20 minutesSingle doses only7-day washout between dosesJournal of Endocrinology and Metabolism2013
Mild or moderate headache was reported by 16 of 23 participants and five reported euphoria only while on active drug. One severe event, a feeling of chest tightness, was judged possibly related to treatment; glucose and IGF-1 did not change relative to placebo.
Oral capsules, single and 7-day dosing (METAOD003 and METAOD004)17 obese men for the single-dose study and 36 obese men for the 7-day study9, 27 or 54 mgOnce dailyOral capsulesSingle doses two weeks apart, then 7 consecutive days2-week washout in the single-dose studyJournal of Endocrinology and Metabolism2013
Headache and digestive complaints were the most common events, with two serious events in the single-dose study, one of which, diarrhea at 54 mg, was judged possibly related. Across 7 days of dosing, IGF-1, fasting glucose, insulin and every oral glucose tolerance test measure stayed unchanged.
12-week oral obesity trial (METAOD005)300 obese adults aged 30 to 65 with a BMI of 35 or more, at 5 Australian hospitals1, 5, 10, 20 or 30 mg (50 people per group)Once dailyOral capsules12 weeks of dosing after a 2-week placebo run-inNoneUS Food and Drug Administration2024
Weight fell faster on every dose than on placebo but without a normal dose response: 0.22 kg per week at 1 mg, 0.15 kg per week at 30 mg and 0.07 kg per week on placebo. The FDA review notes the differences were small and of unclear therapeutic meaning, the company itself confirmed the 1 mg comparison did not reach statistical significance on the primary analysis, and the efficacy results were only ever presented as a conference abstract.
Pivotal 24-week OPTIONS trial (METAOD006)536 adults with obesity enrolled and 502 randomized, aged 18 to 65 with a BMI of 30 to 45, at 16 Australian centers0.25, 0.5 or 1 mgOnce dailyOral tablets24 weeks after a 4-week placebo run-in, with a 4-week follow-upNoneUS Food and Drug Administration2024
Everyone also followed a dietitian-supervised diet and exercise program, and the trial was powered to detect 1.8 kg of weight loss against placebo. Weight loss at both 12 and 24 weeks was too small to reach significance, the company announced on 21 February 2007 that the results did not support commercial viability and ended obesity development, and the study was never published.
Phase 2a nerve pain trial as LAT888153 adults with neuropathic pain from shingles or diabetic peripheral neuropathy30 mg per capsule, 60 mg per day in totalTwice daily, morning and eveningOral capsulesTwo 4-week treatment periods in a crossover design, separated by a washout and a second baseline week14 to 21 days of washout between the two periodsClinicalTrials.gov2019
Lateral Pharma renamed the molecule LAT8881 and tested it for pain rather than weight. Pain scores fell 0.87 points on drug and 0.74 on placebo on an 11-point scale, a difference that was not significant, and the 30% responder rates were 20 of 50 against 19 of 50.

How a course is commonly described

  1. Weeks 1-4Community-reported

    Community protocols start and stay at a flat 300 mcg injected subcutaneously each morning before food, with no titration described. The original trials used oral capsules and tablets at doses from 0.25 mg to 30 mg a day, so nothing in the trial record corresponds to this starting point.

  2. Weeks 5-12Community-reported

    Guides describe the same dose held to week 12, with 6 to 8 weeks framed as the minimum worth running and 300 to 500 mcg as the band most people settle in. The 12-week figure is openly described as borrowed from the trial duration rather than from any measured plateau.

  3. Break, 4-8 weeksCommunity-reported

    A 4 to 8 week off period is the convention, with two cycles a year described as a common annual pattern. No trial tested a break; the obesity studies dosed continuously for 12 or 24 weeks with a placebo run-in before and a short follow-up after.

  4. Clinical comparison, 12 weeksClinical

    The 12-week oral trial in 300 obese adults found weight falling faster on every dose than on placebo but with an inverted dose response and a primary comparison that missed significance. IGF-1 did not change in any group and no antibodies against the peptide were detected at 4, 8 or 12 weeks.

  5. Clinical comparison, 24 weeksClinical

    The larger 24-week trial added a supervised diet and exercise program and tested 0.25, 0.5 and 1 mg a day in 502 randomized adults. Weight loss against placebo at both 12 and 24 weeks was too small to reach significance, and obesity development stopped in February 2007.

  • Every human trial of AOD-9604 used oral or intravenous dosing. FDA reviewers stated in 2024 that they found no human data at all on subcutaneous or transdermal use, which is the route and form sold online.
  • The weight-loss case rests on a 12-week trial whose efficacy results were never published beyond a conference abstract, and the larger 24-week trial with a supervised diet program missed its primary endpoint at both 12 and 24 weeks.
  • Across six trials in roughly 900 people the peptide did not raise IGF-1, did not worsen glucose tolerance and produced no detectable anti-drug antibodies, which is the one consistent positive finding in the record.
  • AOD-9604 is prohibited by WADA and anti-doping laboratories screen urine for it and for a stable metabolite. An FDA advisory committee voted 12 to 0 in December 2024 against adding either the free base or the acetate to the list of bulk substances allowed in compounding.
Sources for this section (12)
  1. Safety and Tolerability of the Hexadecapeptide AOD9604 in HumansJournal of Endocrinology and Metabolism2013Clinical
  2. AOD-9604-Related Bulk Drug Substances: FDA Briefing Document for the December 4, 2024 Pharmacy Compounding Advisory Committee MeetingUS Food and Drug Administration2024Clinical
  3. Final Summary Minutes of the Pharmacy Compounding Advisory Committee Meeting, December 4, 2024US Food and Drug Administration2024Clinical
  4. Oral LAT8881 in Neuropathic Pain (NCT03865953)ClinicalTrials.gov2019Clinical
  5. A Phase IIa Study of the Efficacy and Safety of Oral LAT8881 in Neuropathic Pain: Study ProtocolLateral Pharma (ClinicalTrials.gov document archive)2019Preclinical
  6. A Two-part Proof-of-Concept Study Assessing the Safety and Efficacy of LAT8881 in Lumbar Radicular Pain (NCT05298306)ClinicalTrials.gov2022Clinical
  7. Investigational Drugs for the Treatment of Postherpetic Neuralgia: Systematic Review of Randomized Controlled TrialsInternational Journal of Molecular Sciences (PubMed Central)2023Clinical
  8. Detection and in vitro metabolism of AOD9604Drug Testing and Analysis (PubMed)2015Preclinical

Plus 4 community resources (dosing guides, forum threads and vendor write-ups), reported above but not linked.

Overview

AOD-9604 is a 16-amino-acid peptide taken from the tail end of human growth hormone, residues 177 to 191, with a tyrosine added at the front to stabilize it and a disulfide bond closing a loop between its two cysteines. It came out of Monash University in Melbourne and was developed by Metabolic Pharmaceuticals as an oral obesity tablet across six trials in roughly 900 people between 2001 and 2006, none of which showed a convincing weight-loss effect. The pivotal 24-week study missed its primary endpoint and the company ended obesity development in February 2007; the molecule was later renamed LAT8881 by Lateral Pharma and tested for nerve pain, where it again failed to separate from placebo. It is approved nowhere, is prohibited by WADA, and an FDA advisory committee voted in December 2024 against adding it to the list of substances allowed in pharmacy compounding.

What researchers are exploring

These themes describe recurring questions in published research. They are not claims of effectiveness or recommendations for use.

  • 1

    Obesity drug development

    AOD9604 advanced through several randomized clinical studies.

  • 2

    Metabolic mechanism

    Preclinical work explored lipolysis without full-length GH signaling.

  • 3

    Human tolerability

    Six trials were summarized for glucose, IGF-1, immunogenicity, and adverse events.

  • 4

    Negative efficacy result

    The large 24-week phase 2b trial failed its primary weight-loss endpoint.

What the current evidence can support

Study models remain visible so laboratory and animal findings are not mistaken for established human outcomes.

  • Human

    Six-trial safety summary

    Published pooled safety reporting found no GH-like IGF-1 or glucose signal over the studied periods.

  • Human

    Phase 2b efficacy failure

    Development for obesity stopped after no significant weight-loss benefit in the larger 24-week study.

  • Animal

    Preclinical lipolysis signal

    Rodent findings motivated clinical development but did not translate into pivotal efficacy.

Amounts recorded for AOD9604

These amount records are independent from vial strength, reconstitution volume and measuring device. A recorded source is not the same as study backing, and these values are not recommendations.

  • 1
    Dose · lower endpointSign in for schedule, duration and source context.
    100 mcg
  • 2
    Recorded referenceSign in for schedule, duration and source context.
    250 mcg
  • 3
    Dose · upper endpointSign in for schedule, duration and source context.
    500 mcg

Chemistry identifiers

Sequence, synonyms and registry identifiers as recorded in PubChem, the National Library of Medicine's open chemistry database. Formula, mass and CAS number are summarized at the top of the page.

Sequence

Tyr-Leu-Arg-Ile-Val-Gln-Cys-Arg-Ser-Val-Glu-Gly-Ser-Cys-Gly-Phe (disulfide bond between the cysteines at positions 7 and 14)

Also listed as

AOD 9604, LAT8881, Tyr-hGH(177-191), hGH fragment 177-191, Tyr-somatotropin (177-191), UNII 7UP768IP4M, sh-Oligopeptide-74, AOD-9064

InChIKey

GVIYUKXRXPXMQM-BPXGDYAESA-N

Origin / design

Tyr-hGH177-191 analogue designed to separate lipolytic from GH/IGF-1 effects

IUPAC name

(2S)-2-[[2-[[(4R,7S,13S,16S,19S,22S,25R)-25-[[(2S)-5-amino-2-[[(2S)-2-[[(2S,3S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-amino-3-(4-hydroxyphenyl)propanoyl]amino]-4-methylpentanoyl]amino]-5-carbamimidamidopentanoyl]amino]-3-methylpentanoyl]amino]-3-methylbutanoyl]amino]-5-oxopentanoyl]amino]-22-(3-carbamimidamidopropyl)-13-(2-carboxyethyl)-7,19-bis(hydroxymethyl)-6,9,12,15,18,21,24-heptaoxo-16-propan-2-yl-1,2-dithia-5,8,11,14,17,20,23-heptazacyclohexacosane-4-carbonyl]amino]acetyl]amino]-3-phenylpropanoic acid

Limitations and unknowns

Important limitations

  • A tolerability signal is not evidence of efficacy.
  • The pivotal negative trial is central to interpreting marketing claims.
  • A calculator preset is a recorded research convention, not a recommendation or evidence of clinical benefit.
  • Identity, purity, sterility, and stability can vary substantially outside regulated manufacturing.
  • Route, formulation, and population can make results from one study inapplicable to another use.

Sources

2 curated references, each with its journal, year and study model, plus 4 community resources reported but not linked.

  1. Safety and Tolerability of the Hexadecapeptide AOD9604 in HumansJournal of Endocrinology and Metabolism2013Human
  2. Obesity pharmacotherapy: current perspectives and future directionsCurrent Cardiology Reviews2013Review