AOD-9604 reached human obesity trials. Its pivotal study failed.
Six controlled studies exposed 893 adults to oral or intravenous AOD-9604 development products. The largest study enrolled 536 people, missed its weight-loss endpoints, and ended the obesity program. That record does not support the common claim that a current 5 mg subcutaneous research vial is a proven fat-loss treatment.
Human studies exist, but the strongest weight-loss result was negative.
The OPTIONS study enrolled 536 adults with obesity and randomized 502 to oral AOD-9604 or placebo. FDA reports no statistically significant difference at the 12-week primary weight-loss endpoint or the 24-week secondary endpoint. The sponsor terminated obesity development after the result.
AOD-9604 is not an FDA-approved drug. The FDA advisory committee later voted unanimously against placing its free base and acetate forms on the 503A Bulks List. FDA also found no human exposure data for the subcutaneous and transdermal routes reviewed for compounding.
Read the AOD-9604 record in four fields.
This is a sourced status snapshot, not a safety score, treatment recommendation, or seller certification. Each field links back to the detailed record below.
Six controlled studies
The program covers 893 adults, but only oral and intravenous development products. The pivotal 502-person randomized comparison missed its weight-loss endpoint.
Inspect the human evidenceWeight-loss claim not proven
FDA found a lack of evidence for effectiveness in obesity, and the sponsor ended development after the larger Phase 2b result.
Audit the popular claimsNo approved AOD-9604 drug
Neither free base nor acetate is a component of an FDA-approved drug. The 2024 committee vote for 503A inclusion was 0 to 12.
Check status and destination routesDated US price boards
Sequence, efficacy, route, and seller product cannot be collapsed into one claim.
A credible answer keeps the exact molecule, form, formulation, administration route, study product, population, endpoint, seller lot, and destination attached.
AOD-9604 is a specific 16-amino-acid peptide
PubChem records the sequence YLRIVQCRSVEGSCGF. FDA describes it as human growth hormone residues 177 to 191 with an added N-terminal tyrosine, so a generic HGH fragment label can hide a real identity difference.
The pivotal obesity study missed its weight-loss endpoint
The OPTIONS study enrolled 536 adults and randomized 502 to oral AOD-9604 or placebo. FDA reports no statistically significant weight-loss difference at the 12-week primary endpoint or the 24-week secondary endpoint.
The long obesity studies were oral, not subcutaneous
The six-study safety publication covers intravenous single-dose work and oral capsule or tablet studies. FDA found no human exposure data for the proposed subcutaneous or transdermal routes reviewed for compounding.
A research vial is not a clinical-trial product
A seller-labelled 5 mg vial differs from the oral or intravenous development products in route, formulation, manufacturing record, lot evidence, sterility assurance, supplier, intended use, and regulatory status.
Popular AOD-9604 claims beside the record that limits them.
A mouse study, an earlier human signal, a failed pivotal trial, and a current vial listing answer different questions.
AOD-9604 is a proven fat-loss peptide
Several controlled human studies were performed, and one earlier 12-week study produced a signal in a selected dose group.
FDA concluded that most identified studies failed to show weight-reduction benefit. The larger OPTIONS study did not find a statistically significant difference at its primary or secondary weight-loss endpoints, and development for obesity was terminated.
The pivotal trial had 536 treated participants
The OPTIONS study enrolled 536 adults with obesity and randomized 502 after a run-in period.
Enrollment and randomization are different denominators. The study tested oral 0.25, 0.5, and 1 mg daily doses with diet and exercise support, not a current 5 mg injectable research vial.
AOD-9604 is just HGH fragment 176-191
AOD-9604 was modeled on the C-terminal human growth hormone region and is frequently marketed with HGH fragment language.
FDA and PubChem define AOD-9604 as a 16-amino-acid sequence containing hGH residues 177 to 191 plus an added N-terminal tyrosine. A seller should prove the exact sequence, form, and product rather than rely on a loose alias.
Human trials prove injections are safe
The published program included early single-dose intravenous studies and longer oral studies in 893 adults.
FDA found no human exposure data for subcutaneous or transdermal AOD-9604 and highlighted immunogenicity, aggregation, peptide-impurity, endotoxin, and characterization gaps. Oral and intravenous findings cannot validate a different route or seller lot.
AOD-9604 is FDA approved
FDA evaluated AOD-9604 free base and acetate for possible inclusion on the 503A Bulks List and reviewed historical human research.
Neither form is a component of an FDA-approved drug. The advisory committee voted 0 to 12 on placing the two forms on the 503A Bulks List. A compounding review is not a drug approval review.
No adverse-event reports means no safety risk
FDA's FAERS and literature searches did not retrieve postmarket case reports through the cited search dates.
FDA explicitly says a lack of reports does not imply safety. The clinical summaries were limited, long-term safety was insufficient, route-specific data were missing, and a 2021 sterile compounded-product recall shows why product quality remains separate from molecule-level reports.
A COA proves an AOD-9604 vial will work
A matched report may support a limited result for the exact sample tested, such as identity, purity, quantity, or a named contaminant test.
It does not prove clinical effectiveness, sterility unless that exact test was performed, patient-vial custody, lawful supply, FDA approval, or equivalence to the products used in the historical trials.
Six studies, three routes in the market, and one critical mismatch.
The human program used oral and intravenous products. The common subcutaneous research-vial route does not have the same clinical record.
First intravenous dose-escalation study
- Identity
- AOD-9604 development product versus placebo and recombinant hGH
- Design
- Double-blind, placebo-controlled Phase 1 single-dose escalation
- Participants
- 15 healthy adult men
The study assessed acute safety and laboratory responses across intravenous doses. It was not a weight-loss efficacy trial and does not establish the safety or effectiveness of current subcutaneous research vials.
Intravenous study in men with obesity
- Identity
- Single intravenous AOD-9604 doses versus placebo
- Design
- Double-blind, placebo-controlled crossover Phase 2a study
- Participants
- 23 men with obesity
A severe chest-tightness event and mild to moderate euphoria were assessed as possibly related in the publication. The small acute study cannot define long-term safety, weight-loss benefit, or subcutaneous use.
Early oral safety studies
- Identity
- Oral AOD-9604 capsules versus placebo
- Design
- Single-dose and seven-day double-blind controlled studies
- Participants
- 17 plus 36 men with obesity
These studies explored oral doses from 9 to 54 mg. Headache and gastrointestinal events were common, and one diarrhea serious adverse event was assessed as possibly related. Short exposure and small male cohorts limit interpretation.
Twelve-week oral obesity study
- Identity
- Oral AOD-9604 capsules across five doses versus placebo
- Design
- Randomized, double-blind, placebo-controlled multicenter Phase 2b study
- Participants
- 300 adults with obesity
The publication emphasizes safety and reports similar adverse-event distributions across groups, no significant IGF-1 change, and no detected antibodies in tested samples. It does not provide a complete peer-reviewed efficacy report, and FDA found the available effectiveness summaries insufficient.
Pivotal 24-week obesity study
- Identity
- Oral AOD-9604 tablets at 0.25, 0.5, or 1 mg versus placebo
- Design
- Randomized, double-blind, placebo-controlled multicenter Phase 2b study with diet and exercise support
- Participants
- 536 enrolled; 502 randomized
FDA reports no statistically significant weight-loss difference at 12 weeks or 24 weeks. The sponsor terminated obesity development after concluding that the study did not support commercial viability. Full efficacy methods and results were not published in a conventional peer-reviewed report.
Current registry search
- Identity
- Exact AOD-9604 term search
- Design
- Live ClinicalTrials.gov database query
- Participants
- 0 matching records
The zero-result search means there is no current ClinicalTrials.gov record under the exact term. It does not mean no human studies occurred: the older Australian program is documented through the safety publication, TGA notification history, company records, and FDA's later review.
The result is clearer when the denominators and endpoints stay visible.
Enrollment, randomization, duration, route, and statistical result are separate fields, not interchangeable marketing numbers.
536 enrolled
After the placebo run-in, 502 adults with obesity were randomized to one of three oral doses or placebo with diet and exercise support.
Open the FDA study summary →Not significant at week 12
No AOD-9604 dose produced the prespecified statistically significant weight-loss difference versus placebo at the primary time point.
Inspect the endpoint record →Obesity development ended
The sponsor concluded that the 12-week and 24-week results did not support commercial viability and terminated development for obesity.
Read FDA's conclusion →Oral, intravenous, and subcutaneous are not one evidence lane.
The route changes formulation, exposure, product-quality requirements, and the safety questions a study can answer.
Largest evidence base
The two longer studies tested controlled capsules or tablets. The pivotal oral program did not establish weight-loss effectiveness.
Read the six-study summary →Small acute studies
Two early studies used controlled single-dose infusions in 15 and 23 men. They assessed acute pharmacology and safety, not long-term weight loss.
Inspect the IV records →No human exposure record found
FDA found no human study for the proposed subcutaneous route and highlighted immunogenicity, aggregation, impurity, sterility, endotoxin, and characterization concerns.
Open FDA's route analysis →A current 5 mg research listing is not an obesity-trial product.
These are dated market observations, not a treatment pathway. Price and availability do not establish identity, sterility, effectiveness, approval, lawful personal use, or suitability.
04
The board compares public US 5 mg research listings under one evidence policy and keeps ambiguous stock rows from setting the available low.
Inspect every source row →03
Only explicit availability language enters the count. Each row keeps the seller source, evidence-access note, and checked date attached.
Check source freshness →$44.00-50.00
The range excludes shipping, taxes, coupons, checkout-only discounts, and unresolved stock. It does not estimate clinical value.
Compare landed cost →A US seller page does not establish access in another country.
Country status depends on the exact product, presentation, claimed use, authorization, seller, import route, and current regulator record. SAHPRA and Health Canada have published named AOD-9604 enforcement records, while every other destination needs its own current product and seller checks.
Fifteen AOD-9604 questions, answered from the exact record.
This is educational reporting, not medical advice, a prescription, emergency guidance, or a use protocol.
What is AOD-9604?
AOD-9604 is a synthetic 16-amino-acid peptide modeled on the C-terminal region of human growth hormone. PubChem records the sequence YLRIVQCRSVEGSCGF, while FDA describes it as hGH residues 177 to 191 with an added N-terminal tyrosine. That exact sequence matters because loose terms such as HGH fragment can refer to a different molecular identity.
Does AOD-9604 work for weight loss?
The strongest available answer is no proven clinical benefit. FDA concluded that most identified studies failed to show weight-reduction benefit versus placebo. In the largest study, 536 adults were enrolled and 502 randomized, but oral AOD-9604 did not produce a statistically significant weight-loss difference at the 12-week primary endpoint or the 24-week secondary endpoint. The sponsor then ended development for obesity.
Why do some pages say an AOD-9604 trial was positive?
An earlier 12-week dose-ranging study produced a weight-loss signal in one selected dose group, while the larger later OPTIONS study tested lower oral doses in a broader population with a formal diet and exercise program and did not meet its endpoints. Reporting only the earlier signal omits the more decisive failed study and the sponsor's decision to terminate obesity development.
How many people were in the main AOD-9604 trial?
FDA records 536 enrolled adults and 502 randomized participants in the OPTIONS study. The randomized denominator is the more accurate count for the treatment comparison. Participants received oral AOD-9604 at 0.25, 0.5, or 1 mg daily, or placebo, for 24 weeks with diet and exercise support.
Is AOD-9604 FDA approved?
No. FDA states that neither AOD-9604 free base nor AOD-9604 acetate is a component of an FDA-approved drug. A 2024 advisory review considered whether the two forms should be placed on the 503A Bulks List for compounding, which is a separate question from drug approval. The committee voted 0 to 12 in favor of placing them on that list.
What did the FDA committee decide about AOD-9604 compounding?
At the December 4, 2024 meeting, the Pharmacy Compounding Advisory Committee used one vote for AOD-9604 free base and acetate. The result was 0 yes, 12 no, and 0 abstentions on whether the substances should be placed on the 503A Bulks List. Advisory votes are nonbinding, but the vote is strong current evidence against describing AOD-9604 as an accepted 503A compounding ingredient.
What are the reported AOD-9604 side effects?
The company-linked six-study publication reported headaches and gastrointestinal events across oral and intravenous studies. A severe chest-tightness event and euphoria were assessed as possibly related in one intravenous study, and a diarrhea serious adverse event was assessed as possibly related in an oral study. FDA says the summaries are too limited to establish long-term safety and notes uncertainty around serious events and route-specific risks.
Is injectable AOD-9604 supported by human trials?
Not for the common subcutaneous research-vial route. The historical human program included intravenous single-dose studies and longer oral studies. FDA found no human exposure data for the proposed subcutaneous or transdermal routes and highlighted immunogenicity, aggregation, impurity, endotoxin, and characterization concerns. Evidence from oral tablets or controlled intravenous infusions cannot be transferred to a seller vial.
Is AOD-9604 the same as HGH fragment 176-191?
The names are often used together in marketing, but they should not be treated as automatically interchangeable. FDA and PubChem define AOD-9604 as a 16-amino-acid peptide built from hGH residues 177 to 191 plus an added N-terminal tyrosine. A label that says only HGH fragment 176-191 does not by itself prove the exact AOD-9604 sequence, form, or product identity.
Are there current AOD-9604 studies on ClinicalTrials.gov?
The exact AOD-9604 search returned zero records when checked July 22, 2026. Older Australian trials still occurred and are documented in a 2013 safety publication and FDA's 2024 review. The correct conclusion is zero current ClinicalTrials.gov records, not zero human research.
Is AOD-9604 prohibited in sport?
Yes for athletes governed by the World Anti-Doping Code. WADA's 2026 Prohibited List explicitly names AOD-9604 among prohibited growth-hormone fragments. Anti-doping status is separate from medical approval, general legality, product identity, and the rules that apply to a non-athlete in a specific country.
Can you buy AOD-9604 in the United States?
US websites advertise seller-labelled AOD-9604 research vials, but a visible listing is not an FDA-approved medicine or proof of lawful personal-use supply. FDA states that AOD-9604 is not a component of an approved drug and publishes current compounding safety concerns. Peptide Local's price board records public research listings only and does not convert them into a medical pathway.
What is the status of AOD-9604 in South Africa and Canada?
SAHPRA explicitly names AOD-9604 among peptide products unlawfully marketed in South Africa and requires registration for products intended to treat, prevent, or alter bodily functions. Health Canada has named a seller-labelled 5 mg AOD-9604 product in an unauthorized-product seizure. Each record is country and product specific, so users should still check the exact medicine, seller, and supply route.
What does AOD-9604 cost?
Peptide Local tracks like-for-like public US 5 mg research listings and preserves stock status, source URL, checked date, price per milligram, and document access. The range can change and excludes shipping, tax, coupons, checkout-only discounts, and ambiguous stock rows. A research-vial price is not a medicine price and does not establish effectiveness, quality, legality, or suitability.
What is the correct AOD-9604 dosage?
There is no FDA-approved AOD-9604 label that establishes a dosage for weight loss or personal use. Historical trials tested different controlled oral and intravenous products, doses, and populations. Translating those protocols into instructions for a current subcutaneous research vial would ignore route, formulation, manufacturing, sterility, and clinical-evidence differences, so this guide does not provide a use protocol.
Do not turn a failed oral trial into an injectable research protocol.
The historical studies concern controlled development products, defined routes, trial populations, dose schedules, investigators, and safety monitoring. A current seller-labelled vial has its own identity, form, formulation, sterility, concentration, lot, storage, supplier, and legal record.
Peptide Local does not provide dosing, reconstitution, injection, or treatment instructions for AOD-9604. Anyone evaluating weight-management treatment should use licensed medical care and approved-product evidence rather than translating research-market listings into personal-use guidance.
Open every record behind the guide.
Each source supports only the field described below. Inclusion is not an endorsement, safety score, product authentication, or seller certification.
Move from the molecule to the exact market and country record.
The evidence guide answers whether AOD-9604 has proven benefits and what FDA reviewed. The linked tools answer current price, seller evidence, public reports, sport status, and destination-specific access without mixing those questions.