AOD-9604
Evidence: B-/C+ — Meaningful Human EvidenceMetabolic / Weight Management
Key facts
- Research areaMetabolic / Weight Management
- Study records15
- Study-at-a-Glance1published summaries
- Last updated2026-07-26
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.
In Plain English
A quick, research-focused overview. It does not replace, and cannot outrank, the detailed evidence below.
What is it?
A synthetic C-terminal hGH-region analogue also known as Tyr-hGH177-191 or LAT8881.
Why are researchers interested in it?
It was developed to test whether selected metabolic effects of growth-hormone sequence fragments could be separated from full growth-hormone activity.
What does the evidence look like?
Preclinical metabolic signals exist, but the human obesity-development program did not demonstrate the required efficacy.
Biggest things to know
It is not plain hGH fragment 176-191, it is not an approved weight-loss medicine, route transfer is unsupported, and product characterization is a major concern.
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
15 study records · 1 with a Study-at-a-Glance summary
Human Studies & Clinical Data
No Human Studies & Clinical Data Listed Yet
This section will be updated as sources are added.
Animal / Cell / Preclinical Data(7)
In vitro metabolism and detection of the growth-hormone fragment AOD9604
2015PMID 25208511
- Population / Model
- Analytical and in-vitro metabolism study
- Dose / Duration / Finding
The study characterized AOD9604 and its metabolites for analytical/doping-control detection and described its relationship to the hGH 177-191 region.
Safety note
Analytical detection research is not evidence of weight-loss efficacy or clinical safety.
Fat oxidation and weight loss in obese mice
2001- Population / Model
- Animal model
- Dose / Duration / Finding
AOD exposure — Reported reduced weight gain and increased fat oxidation.
Safety note
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
2001PMID 11673763 · DOI 10.1038/sj.ijo.0801740
- Population / Model
- Dose / Duration / Finding
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
2001PMID 11713213
- Population / Model
- Obese mice and beta3-adrenergic receptor-knockout mice
- Dose / Duration / Finding
Chronic AOD9604 exposure was evaluated for body-weight and lipid-metabolism effects in mouse models.
Safety note
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
2000PMID 11146367
- Population / Model
- Obese Zucker rats
- Dose / Duration / Finding
AOD9604 was associated with reduced weight gain and altered fat metabolism in obese rats.
Safety note
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
1993PMID 8358331
- Population / Model
- Rat adipose-tissue/animal models
- Dose / Duration / Finding
A peptide corresponding to the hGH 177-191 region showed antilipogenic effects in rat experimental systems.
Safety note
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
1993PMID 8118430
- Population / Model
- Rat adipocytes
- Dose / Duration / Finding
The hGH C-terminal fragment was evaluated for effects on glucose transport in rat fat cells.
Safety note
Cell-model metabolic findings cannot be used as human dosing or outcome evidence.
Regulatory Documents & Official Trial Registries(5)
A Phase IIa study of the efficacy and safety of oral LAT8881 in neuropathic pain: protocol and development background
2019NCT03865953
Study-at-a-Glance available
- Population / Model
- Clinical study design with sponsor development summary
- Dose / Duration / Finding
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.
Show full finding
Safety note
Sponsor study-design background is useful regulatory/identity context but does not replace peer-reviewed reporting of each legacy trial.
Key takeaway
This trial tested oral LAT8881 (formerly AOD9604) for nerve pain in 53 adults with diabetes or shingles-related pain. It did not reduce pain more than placebo (-0.87 vs -0.74 points on a 0-10 scale).
Study at a Glance
Study at a Glance
Plain-language summary of: A Phase IIa study of the efficacy and safety of oral LAT8881 in neuropathic pain: protocol and development background
Does the oral peptide LAT8881 (formerly AOD9604) relieve nerve pain?
Evidence status
What was being studied?
Whether LAT8881, a peptide taken as a capsule, reduces chronic nerve pain (neuropathic pain) more than a placebo capsule. The trial record and protocol call the drug LAT8881; the protocol states it was formerly identified as AOD9604, a compound first developed for obesity. This study tested pain only, so its results say nothing about weight loss.
Who participated?
53 adults aged 18 to 75 (average age about 60) with long-lasting nerve pain from diabetic peripheral neuropathy (43 people) or post-herpetic neuralgia, pain that persists after shingles (10 people). 31 were men and 22 women. They were enrolled in Australia (41) and the United Kingdom (12). 25 received LAT8881 first and 28 received placebo first.
How was the study done?
A Phase 2a randomized, double-blind, placebo-controlled crossover trial: every participant took both LAT8881 and placebo, in a random order, so each person acted as their own comparison. Each treatment lasted four weeks (a 30 mg capsule twice a day), separated by a washout of about three weeks. The main measure was the change in average daily pain on an 11-point scale from 0 (no pain) to 10 (worst pain imaginable), from the start to week 4. The efficacy results below are from the per-protocol group (50 people), which left out people with too little exposure to treatment or major protocol deviations. This summary uses only the ClinicalTrials.gov record, its posted results and the registered protocol; no peer-reviewed report was found.
Key results
The main pain measure did not differ from placebo. Average pain fell by 0.87 points (standard deviation 1.53) on LAT8881 and 0.74 points (standard deviation 2.09) on placebo; the net difference was -0.14 points (95% CI -0.76 to 0.49, P=0.67). A 30% pain reduction was reached by 20 of 50 people on LAT8881 and 19 of 50 on placebo, and a 50% reduction by 6 and 9. On the Patient Global Impression of Change scale (above 4 means improvement) scores were 4.5 with LAT8881 and 4.8 with placebo.
| Measure | Group | Timepoint | Reported value |
|---|---|---|---|
| Change in average pain score, 0-10 scale (primary endpoint) | LAT8881 (n=50) | Baseline to week 4 | -0.87 (SD 1.53)Net difference vs placebo -0.14 (95% CI -0.76 to 0.49), P=0.67. Per-protocol group. |
| Change in average pain score, 0-10 scale (primary endpoint) | Placebo (n=50) | Baseline to week 4 | -0.74 (SD 2.09)Per-protocol group. |
| Reached at least a 30% pain reduction | LAT8881 / placebo (n=50 each) | Week 4 | 20 / 19 people |
| Reached at least a 50% pain reduction | LAT8881 / placebo (n=50 each) | Week 4 | 6 / 9 people |
| Patient Global Impression of Change (above 4 = improved) | LAT8881 / placebo (n=50 each) | Week 4 | 4.5 / 4.8 |
| Pain interference with daily life (Brief Pain Inventory), change from baseline | LAT8881 / placebo (n=50 each) | Week 4 | -0.57 / -1.12A larger drop means less interference. |
What does this mean?
Safety findings
No deaths and no serious adverse events were reported (0 of 51 people on either treatment). The registry lists events reported by more than 5% of people. These occurred in 5 of 51 people on LAT8881 and 6 of 51 on placebo. Upper respiratory tract infection affected 3 and 3 people, and headache 2 and 4. Adverse events were collected for up to 93 days.
Important limitations
- The main endpoint showed no difference from placebo, so the trial does not support a pain benefit at this dose and duration.
- Small crossover trial: 53 people enrolled, 50 in the per-protocol efficacy analysis, with four weeks of treatment per period.
- The per-protocol analysis left out people with inadequate treatment exposure or major deviations from the protocol.
- Two different pain conditions were combined (43 diabetic neuropathy, 10 post-herpetic neuralgia) and the posted results do not separate them.
- No peer-reviewed report of this trial was found, so the results rest on the registry's posted data, which are not peer reviewed.
- The registry did not report numbers for rescue-medication use or blood-level (pharmacokinetic) measures; those results are marked not available.
Regulatory context
- Investigational use studied here
- LAT8881 (formerly AOD9604) was studied here as an investigational oral treatment for neuropathic pain.
A search of Drugs@FDA for AOD-9604 and LAT8881 (accessed 2026-10-08) found no application or approved product. No approval or weight-loss claim is made or implied by this trial.
Sources
- Trial record
- ClinicalTrials.gov NCT03865953 — ClinicalTrials.gov
- Sources reviewed
- Trial registry record with posted results.
Other sources for this study (2)
- Study protocol (version 2019-10-09), hosted on ClinicalTrials.gov — ClinicalTrials.gov · Used for the drug's identity (LAT8881, formerly AOD9604) and the study design.Content reviewed for this summary
- FDA Drugs@FDA search for AOD-9604 / LAT8881 (accessed 2026-10-08) — Regulator (FDA / EMA) · No FDA application or approved product was found for either name.Content reviewed for this summary
This summary is a plain-language reading aid written by MitoCore. It does not replace the original study, which remains the authoritative source. Research information only, not medical advice.
ClinicalTrials.gov NCT03865953 protocol, version dated 2019-10-09.
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks
2026- Population / Model
- Dose / Duration / Finding
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.
Show full finding
December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee — FDA Briefing Document
2024- Population / Model
- Dose / Duration / Finding
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.
Show full finding
FDA Evaluation of AOD-9604-Related Bulk Drug Substances
2024- Population / Model
- Dose / Duration / Finding
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.
Show full finding
FDA review of AOD-9604-related bulk drug substances for the Section 503A Bulks List
2024- Population / Model
- Regulatory chemistry, effectiveness, and safety review
- Dose / Duration / Finding
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.
Safety note
FDA discussed potential immunogenicity, aggregation/degradation, formulation uncertainty, limited effectiveness evidence, and incomplete safety information.
Review Articles / Secondary Sources(3)
Safety and metabolism of AOD9604
2014- Population / Model
- Safety/metabolism paper
- Dose / Duration / Finding
Toxicology/pharmacokinetics — Reports safety-focused data; efficacy claims remain limited.
Safety note
Secondary source; useful for context but not a substitute for primary study review.
AOD-9604 Development Summary
PMID 15134286
- Population / Model
- Dose / Duration / Finding
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
PMID 41966639
- Population / Model
- Dose / Duration / Finding
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: Content pending review. Last updated 2026-07-26.
Follow research updates for AOD-9604
Get notified in your MitoCore account when this profile is updated, a new study is added, or its evidence grade changes.
Get updates when new studies or safety notes are added for this peptide.
Get educational updates on new studies, evidence-grade changes, and safety notes. Educational content only — not medical advice.