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Weight LossModerate Evidence

AOD-9604 (Advanced Obesity Drug 9604 / Tyr-hGH Fragment 176-191)

AOD-9604 is a 16-amino-acid fragment of human growth hormone (residues 176-191) that stimulates fat breakdown and blocks new fat formation through beta-3 adrenergic receptors. Unlike full HGH, it doesn't raise IGF-1 or affect glucose. Six human trials showed good safety, but Phase IIb failed its primary weight loss endpoint.

FormBlends Peptide Context

Reviewed May 14, 2026

Use Aod 9604 peptide guide as a decision-support page, not a shortcut. Its job is to frame benefits, dosing, evidence strength, sourcing, and safety boundaries in one place, especially where the search overlaps with peptide therapy. A useful reader should leave with better questions about clinician oversight, evidence quality, safety limits, cost, pharmacy path, and what changes for their own health history.

  • Confirm whether the page is discussing approved care, compounded access, off-label use, or research-only context.
  • Check the date, evidence quality, safety limits, and whether newer clinical or regulatory updates may change the answer.
  • Ask a licensed clinician how the information applies to your history, medications, labs, goals, and risk profile.

Clinical decision snapshot

AOD-9604 authority snapshot

AOD-9604 is evaluated by mechanism, evidence quality, regulatory status, practical access, and safety questions a licensed clinician would need to review before use.

ObesityStubborn fat depositsBody composition optimizationMetabolic health

Evidence signal

Meaningful evidence with limits

Regulatory reality

Expected to return to Category 1 (compoundable) per HHS announcement, pending formal publication

Safety screen

Injection site reactions (redness, swelling), Mild headaches (typically first few days), Occasional dizziness should be reviewed in context.

This page currently connects to 9 source-backed evidence items through visible references or structured citation data.

Decision path

What is the supervised-review path for AOD-9604?

AOD-9604 should be evaluated by evidence quality, safety status, source quality, dosing context, and whether the goal fits a legitimate clinical pathway. This page is a research and decision aid, not a self-prescribing guide.

Peptide
AOD-9604
Category
Weight Loss
Evidence
Meaningful evidence with limits
FDA status
Not FDA approved

Step 1

Check evidence level

AOD-9604 has more human safety data than most research peptides (893+ participants across 6 trials), with tolerability indistinguishable from placebo. The mechanism is well-established through beta-3-AR knockout studies. However, the Phase IIb trial failed its primary endpoint, and all clinical trials used oral dosing, not the subcutaneous injection route that is commonly used today. The safety profile is strong, but the efficacy data for meaningful weight loss is modest at best.

Review evidence

Step 2

Screen safety context

Injection site reactions (redness, swelling), Mild headaches (typically first few days), Occasional dizziness should be discussed in light of history, dose, and source.

Check side effects

Step 3

Confirm access route

If FormBlends offers access, review the product page and provider pathway before deciding.

Review product access

Last updated: April 6, 2026

Typical Dosage

Subcutaneous: 250-500 mcg once daily, administered in the morning on an empty stomach. Clinical trials used 1-30 mg oral doses. The most common community protocol is 300 mcg daily for weeks 1-4, increasing to 500 mcg for weeks 5-12.

Administration

Subcutaneous injection, Oral (clinical trials)

Typical Cost

$40-200/month

FDA Status

Not FDA Approved

Half-Life

Approximately 3 minutes (IV human data). Subcutaneous half-life not well characterized but estimated longer due to depot absorption.

Onset of Action

Fat oxidation increases measurable within days of treatment initiation. Body composition changes typically take 4-8 weeks to become noticeable.

Bioavailability

Approximately 40% oral bioavailability (pig model). Subcutaneous injection provides reliable absorption.

About AOD-9604

AOD-9604 (Advanced Obesity Drug 9604) is a 16-amino-acid synthetic peptide corresponding to residues 176-191 of human growth hormone, with a tyrosine substitution at the N-terminus replacing the native phenylalanine. Its CAS number is 221231-10-3, and its molecular weight is 1,815.10 Da. The key distinction between AOD-9604 and full-length HGH is selectivity. AOD-9604 retains the fat-metabolizing activity of the HGH C-terminal region while completely lacking the growth-promoting, IGF-1-raising, and glucose-disrupting effects of the intact hormone. This was definitively demonstrated in beta-3 adrenergic receptor knockout studies published in Endocrinology (PMID: 11713213): when the beta-3-AR gene was knocked out, AOD-9604 had zero lipolytic effect, confirming that this receptor is the sole mediator of its fat-burning activity. AOD-9604 completed more human clinical trials than most research peptides. Six randomized, double-blind, placebo-controlled studies enrolled approximately 893 participants. The Phase IIa trial (12 weeks) showed treated subjects lost an average of 2.8 kg versus 0.8 kg for placebo, more than triple the weight loss. But the larger Phase IIb trial (24 weeks, n=536) produced more modest results that failed to achieve statistical significance for its primary endpoint. Metabolic Pharmaceuticals (Melbourne, Australia) ceased drug development in 2007. On the safety side, results across all trials was excellent. Tolerability was indistinguishable from placebo, with no serious adverse events attributed to AOD-9604 and no participant withdrawals due to treatment-related effects. No impact on insulin sensitivity, glucose tolerance, IGF-1, or any somatotropic axis parameter was observed. AOD-9604 received FDA GRAS (Generally Recognized as Safe) status as a food/nutraceutical ingredient, which is a separate regulatory pathway from drug approval. In December 2024, the FDA placed AOD-9604 on the Category 2 compounding list, but HHS Secretary Kennedy's February 2026 announcement indicated it would return to Category 1 (compoundable) status. AOD-9604 should not be confused with HGH Fragment 176-191 (the unmodified native sequence). The single tyrosine-for-phenylalanine substitution at the N-terminus improves peptide stability and receptor interaction. Every human safety and efficacy data point comes from AOD-9604 specifically, not the unmodified fragment, which has never been tested in humans. The most common subcutaneous protocol uses 250-500 mcg daily on an empty stomach, though this dosing is community-derived and does not have direct clinical trial equivalence (all human trials used oral administration at 1-30 mg doses). AOD-9604 is frequently stacked with CJC-1295/ipamorelin for body recomposition or with BPC-157 for combined fat loss and tissue repair protocols.

How AOD-9604 Works

AOD-9604 works primarily through upregulation of beta-3 adrenergic receptors (beta-3-AR) in adipose tissue. This was confirmed in knockout studies where beta-3-AR deficient mice showed no lipolytic response to the peptide. The beta-3-AR activation increases cAMP-mediated hormone-sensitive lipase activity, directly stimulating fat breakdown. AOD-9604 also inhibits de novo lipogenesis, preventing new fat storage while existing fat is mobilized. Unlike full-length HGH, it does not stimulate IGF-1 production, does not affect glucose metabolism, and does not carry the growth-promoting or diabetogenic effects of intact growth hormone.

Receptor targets:

Beta-3 adrenergic receptor (beta-3-AR) in adipose tissue

Benefits

  • Stimulates lipolysis without IGF-1 elevation
  • Inhibits new fat formation (lipogenesis)
  • No impact on insulin sensitivity or glucose metabolism
  • Phase IIa showed triple the weight loss vs placebo (2.8 kg vs 0.8 kg)
  • Increases overall fat oxidation rates
  • FDA GRAS status for food/nutraceutical use
  • Well-tolerated across 893+ clinical trial participants with safety indistinguishable from placebo

What Does the Research Say?

AOD-9604 has more human safety data than most research peptides (893+ participants across 6 trials), with tolerability indistinguishable from placebo. The mechanism is well-established through beta-3-AR knockout studies. However, the Phase IIb trial failed its primary endpoint, and all clinical trials used oral dosing, not the subcutaneous injection route that is commonly used today. The safety profile is strong, but the efficacy data for meaningful weight loss is modest at best.

The effects of human GH and its lipolytic fragment (AOD9604) on lipid metabolism following chronic treatment in obese mice and beta(3)-AR knock-out mice

Endocrinology, 2001 · DOI · PubMed

Confirmed beta-3 adrenergic receptor as the required receptor for AOD-9604 lipolytic action; knockout mice were completely unresponsive

Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone

Journal of Molecular Endocrinology, 2000 · PubMed

Demonstrated AOD-9604 stimulates lipolysis and inhibits lipogenesis in obese Zucker rats without any diabetogenic effects

Increase of fat oxidation and weight loss in obese mice caused by chronic treatment with human growth hormone or a modified C-terminal fragment

International Journal of Obesity, 2001 · PubMed

Chronic AOD-9604 treatment increased fat oxidation and reduced body weight in obese mice without affecting IGF-1 levels

PubMed evidence trail

Research sources used to frame this page

For AOD-9604, FormBlends checks the page topic against primary trials, systematic reviews, guidelines, and current PubMed-indexed literature where available. These citations are context, not a claim that every study applies to every patient.

Potential Side Effects

  • Injection site reactions (redness, swelling)
  • Mild headaches (typically first few days)
  • Occasional dizziness
  • Mild GI symptoms (diarrhea, flatulence, nausea)
  • Fatigue during initial treatment

Drug Interactions

CompoundInteractionSeverity
Diabetes medications (insulin, metformin)Although AOD-9604 did not affect glucose in trials, combining with glucose-lowering agents warrants blood glucose monitoring.minor
Thyroid medications (levothyroxine)Both affect metabolic rate and fat metabolism. Ensure thyroid status is stable before starting AOD-9604.minor

Who Is AOD-9604 For?

Women

No sex-specific contraindications identified in clinical trial data. Contraindicated in pregnancy and breastfeeding due to lack of safety data.

Adults Over 50

Generally favorable safety profile across ages in clinical trials. No specific dosing adjustments recommended. May complement age-related metabolic slowdown protocols.

Athletes

Not currently on WADA's prohibited list specifically, but athletes should verify with their governing body. The HGH fragment class may be subject to interpretation under anti-doping rules.

Regulatory Status

FDA Approved

No

Compounding Legal

No

2026 HHS Status

Expected to return to Category 1 (compoundable) per HHS announcement, pending formal publication

AOD-9604 was placed on the FDA Category 2 list in December 2024 (not eligible for compounding). HHS Secretary Kennedy announced in February 2026 that approximately 14 peptides including AOD-9604 would return to Category 1 (compoundable), but the formal FDA reclassification has not yet been officially published.

Last verified: 2026-04-06

Stacking Options

AOD-9604 is commonly stacked with the following peptides for enhanced results:

Conditions Addressed

ObesityStubborn fat depositsBody composition optimizationMetabolic health

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Frequently Asked Questions

What is AOD-9604?
AOD-9604 is a 16-amino-acid fragment of human growth hormone (residues 176-191) that stimulates fat breakdown and blocks new fat formation through beta-3 adrenergic receptors. Unlike full HGH, it doesn't raise IGF-1 or affect glucose. Six human trials showed good safety, but Phase IIb failed its primary weight loss endpoint.
What are the benefits of AOD-9604?
Stimulates lipolysis without IGF-1 elevation. Inhibits new fat formation (lipogenesis). No impact on insulin sensitivity or glucose metabolism. Phase IIa showed triple the weight loss vs placebo (2.8 kg vs 0.8 kg). Increases overall fat oxidation rates. FDA GRAS status for food/nutraceutical use. Well-tolerated across 893+ clinical trial participants with safety indistinguishable from placebo.
What is the typical dosage for AOD-9604?
Subcutaneous: 250-500 mcg once daily, administered in the morning on an empty stomach. Clinical trials used 1-30 mg oral doses. The most common community protocol is 300 mcg daily for weeks 1-4, increasing to 500 mcg for weeks 5-12.
What are the side effects of AOD-9604?
Common side effects include Injection site reactions (redness, swelling), Mild headaches (typically first few days), Occasional dizziness, Mild GI symptoms (diarrhea, flatulence, nausea), Fatigue during initial treatment.
How much does AOD-9604 cost?
$40-200/month depending on dose and source. Through a compounding pharmacy: $40-80 per 5mg vial from research suppliers.
Is AOD-9604 FDA approved?
Not FDA approved. AOD-9604 was placed on the FDA Category 2 list in December 2024 (not eligible for compounding). HHS Secretary Kennedy announced in February 2026 that approximately 14 peptides including AOD-9604 would return to Category 1 (compoundable), but the formal FDA reclassification has not yet been officially published.
How strong is the evidence for AOD-9604?
AOD-9604 has more human safety data than most research peptides (893+ participants across 6 trials), with tolerability indistinguishable from placebo. The mechanism is well-established through beta-3-AR knockout studies. However, the Phase IIb trial failed its primary endpoint, and all clinical trials used oral dosing, not the subcutaneous injection route that is commonly used today. The safety profile is strong, but the efficacy data for meaningful weight loss is modest at best.