AOD-9604
Evidence: B-/C+ — Meaningful Human EvidenceMetabolic / Weight Management
Evidence Snapshot
What this grade covers
D for rodent metabolic research; E-level support for current human fat-loss claims because the obesity program failed its primary efficacy endpoint and no approved indication exists.
Regulatory Context
AOD-9604 is not FDA-approved for obesity or weight loss. FDA proposed against placing AOD-9604 free base and acetate on the 503A Bulks List, and the advisory committee voted 0-12 against placement in December 2024. FDA’s current safety summary continues to identify immunogenicity, impurity, characterization, and limited safety-information concerns.
Research Takeaway
AOD-9604 is Tyr-hGH177-191: the human-growth-hormone 177-191 region with an additional N-terminal tyrosine. It should not be listed as plain hGH fragment 176-191.
See all 12 evidence claims →Quick Summary
AOD-9604 is a synthetic 16-amino-acid analogue of the human-growth-hormone 177-191 region with an added N-terminal tyrosine. Rodent studies reported lipolytic and weight-related effects, but the sponsor’s human obesity program failed its primary endpoint and was discontinued. FDA has also identified substantial characterization, route-specific safety, impurity, and immunogenicity uncertainties.
Mechanism & Research Overview
In obese rodent models, AOD-9604 was associated with increased lipolysis, reduced lipogenesis, and changes in substrate oxidation and body weight. FDA’s review noted that the human mechanism remains uncertain and is unlikely to operate through the conventional growth-hormone receptor. Preclinical metabolic activity does not establish clinically meaningful human fat loss.
Evidence Claims
Individual scientific statements drawn from the sources cited below, each shown with the specific evidence boundary that statement does not establish.
Supported
AOD-9604 is Tyr-hGH177-191: the human-growth-hormone 177-191 region with an additional N-terminal tyrosine. It should not be listed as plain hGH fragment 176-191.
Sources: In vitro metabolism and detection of the growth-hormone fragment AOD9604
Supported
Preclinical studies report that AOD-9604 can increase fat oxidation or lipolytic activity and reduce weight gain in obese rodents without acting as an hGH-receptor agonist in the tested systems.
Sources: The effects of human GH and its lipolytic fragment (AOD9604) on lipid metabolism following chronic treatment in obese mice and beta3-adrenergic receptor-knockout mice; Increase of fat oxidation and weight loss in obese mice caused by chronic treatment with human growth hormone or a modified C-terminal fragment; AOD9604, a fragment of human growth hormone, reduces body weight and increases lipolysis in obese Zucker rats
Supported
The sponsor’s official protocol history reports six prior clinical trials involving 936 subjects and states that the most recent obesity efficacy study failed its primary endpoint, after which development for obesity was discontinued.
Supported
FDA’s 2024 review concluded that most identified human obesity studies did not show statistically significant weight loss compared with placebo and that evidence did not support effectiveness for obesity.
Sources: December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee — FDA Briefing Document
Supported
Evidence from earlier oral and intravenous development cannot be transferred automatically to subcutaneous, transdermal, or other compounded products.
Sources: December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee — FDA Briefing Document
Supported
AOD-9604 is not an FDA-approved weight-loss medicine, and its failed obesity-development program does not support marketing it as an established fat-loss treatment.
Sources: A Phase IIa study of the efficacy and safety of oral LAT8881 in neuropathic pain: protocol and development background; December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee — FDA Briefing Document
Supported
FDA's December 2024 review proposed that AOD-9604 free base and acetate not be added to the 503A Bulks List, citing inadequate physical and chemical characterization, inconsistent substance identity, lack of evidence of obesity effectiveness, limited safety information, absent human subcutaneous and transdermal data, potential immunogenicity and aggregation, peptide-related impurities, inadequate injectable endotoxin information, and nonclinical bone, liver, and equivocal genotoxicity signals. The review did not establish that compounded AOD-9604 is equivalent to the investigational material used in historic oral or intravenous studies.
Sources: FDA Evaluation of AOD-9604-Related Bulk Drug Substances
Supported
An independent development summary of AOD-9604's clinical program is consistent with FDA's conclusion that the sponsor's human obesity program did not establish efficacy.
Sources: AOD-9604 Development Summary
Supported
A 2026 review of approved and unapproved peptide therapies situates AOD-9604 among unapproved peptides lacking established human efficacy, consistent with FDA's findings and the discontinued obesity development program.
Sources: Safety and Efficacy of Approved and Unapproved Peptide Therapies
Supported
AOD-9604 is not an FDA-approved drug, and FDA has proposed against inclusion of AOD-9604 free base and acetate on the 503A Bulks List while separately identifying compounded AOD-9604 as presenting potential significant safety risks.
Sources: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks; December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee — FDA Briefing Document
Supported
FDA has reported serious adverse events that may be associated with AOD-9604, while explicitly noting that causality is unclear.
Sources: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks
Supported
Grey-market or compounded AOD-9604 products are not equivalent to an FDA-approved medicine and should not inherit efficacy, safety, purity, sterility, or dosing assumptions from research studies.
Sources: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks; December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee — FDA Briefing Document
Safety & Evidence Limitations
Considerations reported in the sources cited on this page — not a complete list of every possible risk, and not medical advice.
Safety Consideration
The sponsor reported that the latest efficacy study did not meet the primary endpoint and discontinued obesity development.Safety Consideration
Older oral or intravenous research does not establish subcutaneous, transdermal, or other compounded-product safety or efficacy.Safety Consideration
Free base and acetate are not the same bulk substance, and FDA found inconsistent naming and incomplete impurity, aggregation, and quality characterization.Safety Consideration
FDA reports limited safety information and potential peptide-related and immunogenicity risks.Safety Consideration
FDA discussed serious events in the development literature but could not establish that AOD-9604 caused all of them.
Research Areas Being Studied
Research areas discussed on this page reflect the Metabolic / Weight Management category and the sources cited below.
Findings Reported in Studies
Educational summary only — reported in cited studies, not a claim of proven benefit.
No Human Study Findings Listed Yet
See preclinical, regulatory, and review sources below.
Study Tables by Evidence Type
Human Studies & Clinical Data
No Human Studies & Clinical Data Listed Yet
This section will be updated as sources are added.
Animal / Cell / Preclinical Data
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| In vitro metabolism and detection of the growth-hormone fragment AOD9604 | 2015 | Analytical and in-vitro metabolism study | The study characterized AOD9604 and its metabolites for analytical/doping-control detection and described its relationship to the hGH 177-191 region. | Analytical detection research is not evidence of weight-loss efficacy or clinical safety. | |
| Fat oxidation and weight loss in obese mice | 2001 | Animal model | AOD exposure — Reported reduced weight gain and increased fat oxidation. | Preclinical only; animal/cell findings do not establish human safety or efficacy. | |
| Increase of fat oxidation and weight loss in obese mice caused by chronic treatment with human growth hormone or a modified C-terminal fragment | 2001 | AOD9604 reduced body-weight gain and increased fat oxidation and lipolysis in obese mice. Unlike intact hGH in this model, it did not bind the hGH receptor or induce hGH-receptor-mediated cell proliferation. | |||
| The effects of human GH and its lipolytic fragment (AOD9604) on lipid metabolism following chronic treatment in obese mice and beta3-adrenergic receptor-knockout mice | 2001 | Obese mice and beta3-adrenergic receptor-knockout mice | Chronic AOD9604 exposure was evaluated for body-weight and lipid-metabolism effects in mouse models. | Mouse findings do not establish clinical effectiveness, appropriate human use, or long-term human safety. | |
| AOD9604, a fragment of human growth hormone, reduces body weight and increases lipolysis in obese Zucker rats | 2000 | Obese Zucker rats | AOD9604 was associated with reduced weight gain and altered fat metabolism in obese rats. | Animal obesity-model results were not confirmed as clinically meaningful weight loss in later human obesity development. | |
| A synthetic peptide corresponding to the C-terminal sequence of human growth hormone inhibits lipogenesis in rat adipose tissue | 1993 | Rat adipose-tissue/animal models | A peptide corresponding to the hGH 177-191 region showed antilipogenic effects in rat experimental systems. | Preclinical metabolic effects do not establish human weight-loss efficacy or safety. | |
| Effects of the C-terminal fragment of human growth hormone on glucose transport in rat adipocytes | 1993 | Rat adipocytes | The hGH C-terminal fragment was evaluated for effects on glucose transport in rat fat cells. | Cell-model metabolic findings cannot be used as human dosing or outcome evidence. |
Regulatory Documents & Official Trial Registries
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | 2026 | FDA lists AOD-9604 among bulk substances for which compounded drug use may present significant safety risks and notes serious adverse events that may be associated with AOD-9604, while stating causality is not clear. This is a regulatory safety signal and not proof of a specific causal toxicity mechanism. | |||
| December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee — FDA Briefing Document | 2024 | FDA's briefing document describes AOD-9604 free base as a 16-amino-acid peptide corresponding to hGH 177-191 with an additional N-terminal tyrosine and evaluates AOD-9604-related bulk substances for the 503A Bulks List. FDA proposed that AOD-9604 free base and acetate not be included on that list. | |||
| FDA Evaluation of AOD-9604-Related Bulk Drug Substances | 2024 | FDA's December 2024 review proposed that AOD-9604 free base and acetate not be added to the 503A Bulks List, citing inadequate physical and chemical characterization, inconsistent substance identity, lack of evidence of obesity effectiveness, limited safety information, absent human subcutaneous and transdermal data, potential immunogenicity and aggregation, peptide-related impurities, inadequate injectable endotoxin information, and nonclinical bone, liver, and equivocal genotoxicity signals. | |||
| FDA review of AOD-9604-related bulk drug substances for the Section 503A Bulks List | 2024 | Regulatory chemistry, effectiveness, and safety review | FDA described AOD-9604 as a 16-amino-acid peptide consisting of the hGH 177-191 fragment with an additional N-terminal tyrosine and identified evidence and product-characterization gaps. | FDA discussed potential immunogenicity, aggregation/degradation, formulation uncertainty, limited effectiveness evidence, and incomplete safety information. | |
| A Phase IIa study of the efficacy and safety of oral LAT8881 in neuropathic pain: protocol and development background | 2019 | Clinical study design with sponsor development summary | The registered study plan identifies LAT8881 as Tyr-hGH177-191, formerly AOD9604, and reports six prior obesity trials involving 936 subjects, with more than 700 subjects receiving oral LAT8881. The final obesity efficacy study did not meet its primary endpoint, and development for the obesity indication ended in 2007. | Sponsor study-design background is useful regulatory/identity context but does not replace peer-reviewed reporting of each legacy trial. | ClinicalTrials.gov NCT03865953 protocol, version dated 2019-10-09. |
Review Articles / Secondary Sources
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Safety and metabolism of AOD9604 | 2014 | Safety/metabolism paper | Toxicology/pharmacokinetics — Reports safety-focused data; efficacy claims remain limited. | Secondary source; useful for context but not a substitute for primary study review. | |
| AOD-9604 Development Summary | An independent summary of AOD-9604's development program, consistent with FDA's conclusion that the sponsor's human obesity program did not establish efficacy. | ||||
| Safety and Efficacy of Approved and Unapproved Peptide Therapies | A 2026 review of approved and unapproved peptide therapies situates AOD-9604 among unapproved peptides lacking established human efficacy, consistent with FDA's findings. |
Anecdotal Reported Patterns — Not Medical Advice
Anecdotal Reported Patterns — Not Medical Advice
Reported dosing patterns are included for educational context only. They are self-reported, unverified, not medical advice, and not instructions for human use. Community-submitted patterns are not yet available in this Phase 1 prototype; this section is a placeholder reserved for moderated, aggregated community data.
Lab Markers to Discuss With a Clinician
Educational topics only — not self-monitoring instructions.
FAQ
Disclaimer
AOD-9604’s rodent metabolic findings and prior investigational program do not establish a safe or effective human fat-loss treatment, and they do not support route-specific instructions for compounded products.
Educational use only. This content is provided for informational and research-summary purposes only. It is not medical advice, not a treatment recommendation, not a dosing guide, and not a substitute for care from a licensed medical professional. Nothing here is intended to diagnose, treat, cure, prevent, or mitigate disease. Reported dosing patterns, when shown elsewhere on the site, must be labeled either as Study / Trial Dosing or Anecdotal Reported Patterns — Not Medical Advice. Community reports are self-reported, unverified, and not scientific proof.
Community-reported experiences, once enabled, must be displayed only as moderated, anonymized, or aggregated data. They are anecdotal, self-reported, unverified, and should never be presented as proof of safety, efficacy, or expected results.
Content status: Website/CMS content draft; source verification and legal/privacy review required before public launch. Last updated 2026-07-26.
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