Overview
Overview
This synergistic blend combines three peptides targeting body composition: AOD-9604 (hGH fragment 177–191) promotes lipolysis without raising IGF-1[1]; CJC-1295 (GHRH analog) produces sustained GH and IGF-1 elevations[2]; and Ipamorelin (ghrelin mimetic) selectively stimulates GH secretion without increasing cortisol or ACTH[3]. Together, these peptides may support lean mass gains and fat reduction[4]. Vial contents: 6 mg AOD-9604 + 3 mg CJC-1295 + 3 mg Ipamorelin (12 mg total). Reconstitute: A
- Category
- Weight Loss
- Routes
- subcutaneous
Mechanism
AOD-9604
Mechanism of action
Mechanism of action
AOD-9604 was designed to copy the fat-metabolism end of human growth hormone without the rest of growth hormone's effects. In simple terms, growth hormone has a region near one end of its molecule that signals fat cells to release stored fat. AOD-9604 is a synthetic copy of that region, plus one extra amino acid for stability. In animal research, AOD-9604 has done two main things. First, it stimulates lipolysis, which is the breakdown of stored fat into free fatty acids the body can use as fuel. Second, it appears to suppress lipogenesis, which is the storage of new fat. In Heffernan et al. 2001, AOD-9604 lost most of this fat-metabolism effect in mice that were genetically missing the beta-3 adrenergic receptor, suggesting that pathway carries part of the signal. Importantly, AOD-9604 does not appear to bind to the growth hormone receptor itself in cell-binding studies. That is the proposed reason it does not raise IGF-1 levels or impair insulin sensitivity in animal work, in contrast to full-length growth hormone. The molecular target that AOD-9604 actually binds is still unidentified, which the FDA explicitly noted in its December 2024 evaluation. A separate animal line of work has investigated AOD-9604 in joint research. Kwon and Park 2015 reported that intra-articular AOD-9604 injections, especially when combined with hyaluronic acid, improved cartilage scores and reduced lameness in a rabbit collagenase-induced osteoarthritis model. This is a single rabbit study, not human evidence. Increased lipolysis, increased fat oxidation, decreased lipogenesis, no apparent effect on plasma glucose or insulin sensitivity, and signal that intact beta-3 adrenergic receptor activity matters for the fat-loss effect. The actual molecular receptor that AOD-9604 binds. FDA's 2024 review states the mechanism of action is still unknown, which limits how confidently any specific physiological effect can be predicted in humans.
Key research findings
- 01
AOD-9604 is a synthetic peptide fragment based on the C-terminal region of human growth hormone (residues 176-191) with an added tyrosine, studied for effects on fat metabolism (mechanistic / in vitro).
- 02
Preclinical work reported lipolytic and anti-lipogenic activity in fat cells and rodent models without the growth-promoting (IGF-1-raising) activity of full growth hormone (in vitro / animal model).
- 03
In human Phase 2 obesity trials by the original developer, AOD-9604 did not show statistically significant weight reduction versus placebo over the studied period (human study, Phase 2).
- 04
Later research explored other contexts such as cartilage/joint research; weight-loss efficacy in humans remained unsupported (animal model / early research).
- 05
It has been the subject of food-ingredient self-affirmed GRAS evaluations in some contexts, but it is not an approved weight-loss drug.
Primary source: Strongest human evidence: The METAOD006 (OPTIONS) Phase 2b trial randomized 502 adults with obesity (BMI 30-45 kg/m^2) to oral AOD-9604 (0.25, 0.5, or 1 mg/day) or placebo for 24 weeks alongside a supervised diet and exercise program. The trial was powered to detect a 1.8 kg difference vs placebo. The primary endpoint was not met. Metabolic Pharmaceuticals terminated development for obesity in February 2007. Earlier oral trial: METAOD005 randomized 300 adults with obesity to oral AOD-9604 (1, 5, 10, 20, or 30 mg/day) or placebo for 12 weeks. Authors reported small statistically significant differences in weekly weight loss at the 1 mg dose with a non-linear dose response, but the abstract data has not been published in full peer-reviewed form. IV and short-duration oral trials: METAOD001-004 enrolled smaller groups of healthy or obese men with single doses or 1-week dosing across IV (25-400 mcg/kg) and oral (9-54 mg) routes. These established short-term safety and pharmacology context but were not designed to demonstrate weight loss efficacy. Preclinical fat-loss evidence: Ng et al. 2000 in Hormone Research showed that 21-day oral AOD-9604 (500 mcg/kg/day) reduced body weight gain by roughly 50% in obese Zucker rats with no insulin sensitivity penalty. Heffernan et al. 2001 in Endocrinology showed reduced body weight gain with 14-day AOD-9604 in obese (ob/ob) mice and identified the beta-3 adrenergic receptor dependency. Preclinical cartilage evidence: Kwon and Park 2015 in Annals of Clinical and Laboratory Science reported that intra-articular AOD-9604 plus hyaluronic acid in a rabbit knee osteoarthritis model improved cartilage histology and reduced lameness compared with hyaluronic acid alone. This is one rabbit study, not human evidence. What is missing: There is no published human pharmacokinetic study of subcutaneous AOD-9604, no published human topical or intranasal exposure data, no Phase 3 efficacy trial, no long-term safety data beyond 24 weeks, and no published human cartilage or joint outcome data.
Pharmacokinetic profile
Single-dose plasma curve over 24h. Shaded band = commonly-cited therapeutic window. Illustrative only.
Researched Effects
Researched benefits
Areas of active research and investigation. Results may vary and are based on preclinical or early clinical data.
Potential Benefits
Supports reduction in fat mass and enhancement of lipolysis[1][5].
May promote lean mass gains through sustained GH and IGF-1 elevation[2][4].
Protocol Reference
Protocol reference
Commonly cited research range: 250–500 mcg, daily.
Reference figures reported in the research literature — not a dosing recommendation. For interactive vial math and scheduling, see the Calculator and Schedule tabs.
Cited protocol & reconstitution guide
Source-backed reference fields by phase, including any volume fields authored in the cited guide.
Week 1
200 mcg AOD / 100 mcg CJC / 100 mcg Ip
Week 2
300 mcg AOD / 150 mcg CJC / 150 mcg Ip
Weeks 3–12
400 mcg AOD / 200 mcg CJC / 200 mcg Ip
| Phase | Reference amount | Units / volume |
|---|---|---|
| Week 1 | 200 mcg AOD / 100 mcg CJC / 100 mcg Ip | 10 units (0.10 mL) |
| Week 2 | 300 mcg AOD / 150 mcg CJC / 150 mcg Ip | 15 units (0.15 mL) |
| Weeks 3–12 | 400 mcg AOD / 200 mcg CJC / 200 mcg Ip | 20 units (0.20 mL) |
Titration protocol
- Initial 4 weeksStart300 mcg
- Maintenance (weeks 5-12)Build500 mcg
- Optional extensionMaintenance300-500 mcg
0.18 18
Storage & Handling
Storage requirements(typical for most peptides)
Can be stored for extended periods. Protect from moisture.
Store in refrigerator door. Never freeze after reconstitution.
Label vials with reconstitution date. Discard if cloudy.
Reconstitution steps
- 01🌡️Draw 3.0 mL bacteriostatic water with a sterile syringe.
- 02🧴Inject slowly down the vial wall; avoid foaming.
- 03💉Gently swirl/roll until dissolved (do not shake).
- 04💧Label and refrigerate at 2–8 °C (35.6–46.4 °F), protected from light.
Additional storage notes
-4F (-20C) long-term — Per supplier safety data sheets, the lyophilized peptide is stable for one year or more under freezer storage. Keep in a dry, dark, sealed container.
35.6-46.4F (2-8C) for short windows — Acceptable for shipment or near-term storage; freeze for longer holding.
35.6-46.4F (2-8C) — Refrigerate. Most research-supply guidance keeps reconstituted vials usable for about 3-4 weeks.
Clear after reconstitution — If the solution is cloudy, contains particles, or has changed color, do not use it.
Clinical Evidence
Clinical evidence
Research shows selective fat reduction, particularly abdominal fat. Does not affect insulin sensitivity or glucose levels.
Strongest human evidence: The METAOD006 (OPTIONS) Phase 2b trial randomized 502 adults with obesity (BMI 30-45 kg/m^2) to oral AOD-9604 (0.25, 0.5, or 1 mg/day) or placebo for 24 weeks alongside a supervised diet and exercise program. The trial was powered to detect a 1.8 kg difference vs placebo. The primary endpoint was not met. Metabolic Pharmaceuticals terminated development for obesity in February 2007. Earlier oral trial: METAOD005 randomized 300 adults with obesity to oral AOD-9604 (1, 5, 10, 20, or 30 mg/day) or placebo for 12 weeks. Authors reported small statistically significant differences in weekly weight loss at the 1 mg dose with a non-linear dose response, but the abstract data has not been published in full peer-reviewed form. IV and short-duration oral trials: METAOD001-004 enrolled smaller groups of healthy or obese men with single doses or 1-week dosing across IV (25-400 mcg/kg) and oral (9-54 mg) routes. These established short-term safety and pharmacology context but were not designed to demonstrate weight loss efficacy. Preclinical fat-loss evidence: Ng et al. 2000 in Hormone Research showed that 21-day oral AOD-9604 (500 mcg/kg/day) reduced body weight gain by roughly 50% in obese Zucker rats with no insulin sensitivity penalty. Heffernan et al. 2001 in Endocrinology showed reduced body weight gain with 14-day AOD-9604 in obese (ob/ob) mice and identified the beta-3 adrenergic receptor dependency. Preclinical cartilage evidence: Kwon and Park 2015 in Annals of Clinical and Laboratory Science reported that intra-articular AOD-9604 plus hyaluronic acid in a rabbit knee osteoarthritis model improved cartilage histology and reduced lameness compared with hyaluronic acid alone. This is one rabbit study, not human evidence. What is missing: There is no published human pharmacokinetic study of subcutaneous AOD-9604, no published human topical or intranasal exposure data, no Phase 3 efficacy trial, no long-term safety data beyond 24 weeks, and no published human cartilage or joint outcome data.
- 01AOD-9604 is a synthetic peptide fragment based on the C-terminal region of human growth hormone (residues 176-191) with an added tyrosine, studied for effects on fat metabolism (mechanistic / in vitro).
- 02Preclinical work reported lipolytic and anti-lipogenic activity in fat cells and rodent models without the growth-promoting (IGF-1-raising) activity of full growth hormone (in vitro / animal model).
- 03In human Phase 2 obesity trials by the original developer, AOD-9604 did not show statistically significant weight reduction versus placebo over the studied period (human study, Phase 2).
- 04Later research explored other contexts such as cartilage/joint research; weight-loss efficacy in humans remained unsupported (animal model / early research).
- 05It has been the subject of food-ingredient self-affirmed GRAS evaluations in some contexts, but it is not an approved weight-loss drug.
Evidence maturity varies by compound; much peptide research is preclinical (in vitro or animal-model). Where human data are limited, findings should be read as research observations, not clinical conclusions.
References
Literature references
Published research articles and sources related to AOD-9604.
- 01Mathew B, Amaechi C, Asante K, Albuquerque E, Benedict A, Kneeream E, Lopez L, et al. FDA Evaluation of AOD-9604-Related Bulk Drug Substances (AOD-9604 (free base) and AOD-9604 acetate). Pharmacy Compounding Advisory Committee Briefing Document. U.S. Food and Drug Administration (2024)et al. (2024)
- 02Stier H, Vos E, Kenley D. Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans. Journal of Endocrinology and Metabolism (2013)et al. (2013)
- 03Heffernan M, Summers RJ, Thorburn A, Ogru E, Gianello R, Jiang WJ, Ng FM. 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)et al. (2001)
- 04Ng FM, Sun J, Sharma L, Libinaka R, Jiang WJ, Gianello R. Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone. Hormone Research (2000)et al. (2000)
- 05Kwon DR, Park GY. Effect of Intra-articular Injection of AOD9604 with or without Hyaluronic Acid in Rabbit Osteoarthritis Model. Annals of Clinical and Laboratory Science (2015)et al. (2015)
- 06Wilding JP. Treatment strategies for obesity (review including AOD-9604 clinical development). Obesity Reviews (2004)et al. (2004)
- 07Cox HD, Lopes F, Woldemariam GA, Becker JO, Parkin MC, Thomas A, Butch AW, Cowan DA, Thevis M, Bowers LD, Hoofnagle AN. Interlaboratory agreement of insulin-like growth factor 1 concentrations measured by mass spectrometry (with discussion of AOD-9604 doping detection). Clinical Chemistry (2014)et al. (2014)
- 08World Anti-Doping Agency. Prohibited List - Section S2: Peptide Hormones, Growth Factors, Related Substances, and Mimetics. World Anti-Doping Agency (2026)et al. (2026)
- 09Metabolic Pharmaceuticals Limited. OPTIONS Study Phase 2b results announcement (AOD-9604 development terminated). Australian Stock Exchange filing (2007)et al. (2007)
- 10More VG, Kenley DC. Safety evaluation of AOD9604, a synthetic peptide for use in obesity. International Journal of Toxicology (2014)et al. (2014)
- 11DrugBank. AOD9604 drug summary. DrugBank Online (2026)et al. (2026)
Observed Effects
Observed effects in cited research
Observed effects in human trials
- Reported adverse events across the IV and oral trials included headache, fatigue, dizziness, nasopharyngitis, diarrhea, flatulence, increased appetite, nausea, and back pain. Most were mild or moderate. One report of severe chest tightness in the 50 mcg/kg IV arm was deemed possibly related. A small number of cancers (basal cell carcinoma, breast cancer, malignant melanoma, lipoma, squamous cell carcinoma) were reported during the 12-week oral METAOD005 trial; investigators considered them unrelated to study drug. Anti-AOD-9604 antibodies were not detected in tested participants.
Theoretical and route-specific risks
- FDA's 2024 review specifically flagged that no published human exposure data exists for the subcutaneous, transdermal, or intranasal routes that compounding pharmacies have offered. Injectable routes carry a particular concern for immunogenicity from peptide aggregation and impurities, and FDA noted the available certificates of analysis for AOD-9604 bulk drug substances did not consistently control for impurities, aggregates, or microbial limits.
Animal toxicology signals
- Two animal findings reviewed by FDA are worth tracking even if they did not surface clinically. In a 26-week rat oral toxicity study, AOD-9604 produced dose-dependent changes in serum osteocalcin (a bone-turnover marker) at week 13, with the direction reversing by week 26. In a 9-month monkey oral toxicity study, all female monkeys in the high-dose group showed minimal-to-slight periportal hepatocyte vacuolation. FDA flagged both as potentially clinically relevant signals that warrant caution.
Quality-control risk
- Because there is no FDA-approved AOD-9604 product, all material in circulation comes from research-supply or compounding sources. FDA noted that reviewed CoAs from suppliers did not consistently include controls for impurities, aggregates, or bacterial endotoxins. That makes supplier transparency, third-party HPLC purity confirmation, and lot-specific certificates non-negotiable for any research-context sourcing.
Research Considerations
Research considerations
Research peptide. Generally well-tolerated. Consult healthcare provider.
- AOD-9604 is a research compound. Anyone considering it should consult a qualified clinician before use. There is no FDA-approved indication for any patient population.
- Published human trials with AOD-9604 enrolled adults with obesity (BMI 30-45 kg/m^2), generally aged 18-65. Outside of that group, published safety data is essentially absent. The following populations have no published exposure data and would generally be excluded from research-context use:
- - People who are pregnant, trying to become pregnant, or breastfeeding. - Anyone under 18. - People with active or recent cancer history (the trial record contains a small number of cancers in the 12-week oral arm; investigators considered them unrelated, but no long-term oncology safety data exists). - People with significant liver disease (the 9-month monkey toxicology study showed dose-dependent periportal vacuolation in hepatocytes that the FDA flagged as a possible safety signal). - People with poorly controlled bone-turnover conditions, until the dose-dependent osteocalcin changes seen in the 26-week rat study are better understood.
- AOD-9604 is on the World Anti-Doping Agency Prohibited List under category S2.2 (peptide hormones, growth factors, related substances, and mimetics). Athletes subject to WADA, USADA, NCAA, or any sport-governing-body testing should not use AOD-9604 in any form. Metabolites can be detected in urine.
- Specific drug-interaction studies with AOD-9604 have not been published. Any medication that affects glucose, lipid metabolism, growth hormone signaling, or beta-adrenergic activity could in theory interact, but evidence is absent. Discuss any active prescription with a qualified clinician before considering use.
Factors noted in the research literature; not patient-specific medical advice.
Regulatory Status
Regulatory status
RUO
Comparisons
Comparisons
| Compound | Mechanism | Route | Status |
|---|---|---|---|
| AOD-9604this | Stimulates lipolysis and inhibits lipogenesis. Fragment retains fat-reducing properties without metabolic side effects of full GH. | subcutaneous | Investigational / RUO |
| Cagrilintide | A long-acting acylated amylin analog that activates central amylin (calcitonin-family) receptors to promote satiety and slow gastric emptying. | subcutaneous | Investigational / RUO |
| L-Carnitine | An amino acid derivative essential for transporting long-chain fatty acids into mitochondria for beta-oxidation and energy production. | subcutaneous | Investigational / RUO |
| Mazdutide | A long-acting dual agonist of GLP-1 and glucagon receptors, combining GLP-1 appetite/glycemic signaling with glucagon-mediated energy expenditure. | subcutaneous | Investigational / RUO |
| MOTS-C | A 16-amino-acid mitochondrial-derived peptide encoded in the 12S rRNA region of mtDNA that activates AMPK and influences nuclear stress-response gene expression, studied for metabolic homeostasis. | subcutaneous | Investigational / RUO |
| Ara-290 | An 11-amino-acid non-erythropoietic peptide derived from erythropoietin's helix-B domain that selectively activates the innate repair receptor (an EPOR/CD131 heterocomplex), studied for tissue protection and resolution of inflammation. | subcutaneous | Investigational / RUO |
| BPC-157 | Promotes angiogenesis, accelerates wound healing, and protects organs. Interacts with growth hormone receptors and NO system. | subcutaneous, intramuscular | Investigational / RUO |
Attributes shown for research comparison only; not a statement of efficacy or therapeutic equivalence.
FAQ
Frequently asked questions
AOD-9604 is a 16-amino-acid synthetic peptide. It is a fragment of human growth hormone (positions 177-191) with an extra tyrosine added at one end for stability. It was originally developed in Australia by Metabolic Pharmaceuticals as an investigational obesity drug and is also called HGH Fragment 176-191.
They refer to the same C-terminal region of growth hormone. AOD-9604 is the stabilized, formally studied form with an extra tyrosine residue. HGH Fragment 176-191 is the more general scientific name. In practice, the names are used interchangeably, but AOD-9604 is the version that completed the published Phase 1/2 trials.
No. AOD-9604 is not FDA-approved for any therapeutic use. As of June 2026, the FDA's December 2024 Pharmacy Compounding Advisory Committee evaluation concluded that the criteria weighed against placing AOD-9604 (free base) or AOD-9604 acetate on the 503A Bulks List, and AOD-9604 is currently listed as Nominated but Withdrawn from FDA Category 2.
Published trials used oral doses of 0.25 mg to 30 mg per day and intravenous single doses of 25 to 400 mcg/kg. The largest Phase 2b trial used 0.25, 0.5, and 1 mg/day orally for 24 weeks. Most current research-context subcutaneous protocols cite 300-500 mcg/day, but no published human pharmacokinetic study has formally evaluated the subcutaneous route. This is not a dosing recommendation.
Cell-binding studies show AOD-9604 does not bind to the growth hormone receptor in the same way as full hGH. Across the published trials in Stier et al. 2013, no statistically significant changes in IGF-1 or fasting glucose were detected versus placebo. Animal studies similarly did not show insulin sensitivity changes. This is one of the main differences between AOD-9604 and full-length human growth hormone.
The largest published trial (METAOD006/OPTIONS) randomized 502 adults with obesity to AOD-9604 or placebo for 24 weeks alongside a diet and exercise program. The primary weight-loss endpoint was not met. Metabolic Pharmaceuticals terminated development for obesity in 2007 for that reason. Earlier shorter trials reported small statistically significant differences but the effect sizes were modest.
A 5 mg lyophilized vial is most often reconstituted with 3.0 mL of bacteriostatic water. That gives roughly 1.667 mg/mL. At that concentration, a 300 mcg dose is about 0.18 mL (18 units on a U-100 syringe) and a 500 mcg dose is about 0.30 mL (30 units). Always recalculate if you use a different vial size or water volume, and use the PepPal calculator to confirm.
Across the six published trials, the most common adverse events were headache, mild gastrointestinal effects (diarrhea, flatulence, nausea), nasopharyngitis, fatigue, dizziness, and mild injection-site reactions. Most were mild or moderate. No participants developed anti-AOD-9604 antibodies in the subset tested, and no statistically significant changes in IGF-1 or vital signs were seen.
AOD-9604 is sometimes discussed alongside BPC-157 in joint research planning, and historically alongside GH secretagogues like Sermorelin , Ipamorelin , and GHRP-6 in fat-loss research planning. There is no controlled human trial data on these combinations. Each compound has its own evidence and regulatory profile.
Yes. AOD-9604 is on the World Anti-Doping Agency Prohibited List under category S2.2 (peptide hormones, growth factors, related substances, and mimetics). Athletes subject to WADA, USADA, NCAA, or other sport-governing-body testing should not use it. Metabolites can be detected in urine.
Phase 2 trials ran 12 weeks (METAOD005) and 24 weeks (METAOD006/OPTIONS). Community research planning often mirrors that 8-16 week range. There is no published evidence base for cycles longer than 24 weeks, so any extended use is unsupported by trial data.
No. This page is an educational research reference. Information here is drawn from the published trial record, FDA regulatory documents, and animal studies. Always consult a qualified clinician before considering any peptide. AOD-9604 is not approved by the FDA for any therapeutic use.
Research-use notice
Research Use Only. This educational content and calculation support is intended for private research documentation. It does not provide medical advice, human-use directions, or claims of safety or effectiveness.