12 weeks
Earlier oral obesity study period; efficacy findings were limited.
Protocol / Research Dosing Guide
AOD-9604 Dosage Guide: Research Schedule, Reconstitution and Safety
An evidence-organized AOD-9604 guide separating failed oral clinical development and animal research from unvalidated subcutaneous community protocols.
Last reviewed September 15, 202619 minute readResearch information only
Level 4 — Human trialsPrimary obesity endpoint not metNot FDA approved
AOD-9604 Quick Start
AOD-9604 is a modified C-terminal human-growth-hormone fragment developed as an oral obesity candidate. The largest 24-week study did not separate from placebo on its primary weight-loss endpoint, and development for obesity was discontinued.
Why researchers care
Metabolic and cartilage research
Class
Modified human growth hormone fragment 176–191
Route reported
Oral in pivotal trials; SC community reports
Cycle length
12–24 weeks studied orally; SC cycle not established
Regulatory status
Not FDA approved
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AOD-9604 Dosing Protocol and Schedule
The supplied source reports a subcutaneous community range of 300–500 mcg daily. No published human subcutaneous pharmacokinetic study validates this range or schedule.
| Phase or study | Amount | Frequency / evidence |
|---|---|---|
| Weeks 1–4 | 300 mcg once daily | Community reported |
| Weeks 5–12 | 500 mcg once daily | Community reported |
| Optional extension | 300–500 mcg once daily | Community reported; not validated |
Published obesity trials used oral administration over fixed 12- and 24-week study periods. Those oral trial designs do not validate the subcutaneous schedule.
AOD-9604 Supplies Needed
Neutral research-material planning only. This does not establish an appropriate amount or route.
Research planning item
Exact labeled research vial
Research planning item
Measured diluent volume
Research planning item
U-100 measurement reference
Research planning item
Alcohol swabs
Research planning item
Appropriate sharps container
Research planning item
Written concentration label
AOD-9604 Reconstitution Calculator
Vial-format concentration math
Concentration
1.667 mg/mL
Draw volume
0.18 mL
U-100 units
18
Mathematical draws
16
Arithmetic only. The entered amount is not a recommendation and does not establish suitability.
Best Time to Take AOD-9604: Morning or Night?
Morning or evening?
Not established for subcutaneous use.
Once daily?
Once-daily use is community reported; oral trials used daily administration.
With food?
Not established for research-vial use.
Missed amount?
No validated subcutaneous missed-amount instructions exist.
AOD-9604 Route Comparison
| Route | Research context | Evidence limit |
|---|---|---|
| Oral | 0.25, 0.5, and 1 mg/day in the 24-week Phase 2b program | Primary weight-loss endpoint not met |
| Intravenous | Single-dose early studies reported by the development program | Does not validate SC use |
| Subcutaneous | 300–500 mcg/day in community reports | No published human SC PK |
| Topical or nasal | No established exposure data | Not validated |
Routes and amounts are not interchangeable unless a verified study explicitly establishes a conversion.
AOD-9604 Half-Life and Dosing Frequency
| Measure | Finding | Evidence limit |
|---|---|---|
| Human SC half-life | Not established | No published SC PK |
| Human oral half-life | Not established in a verified primary source | Do not infer frequency |
| Frequency | Daily in oral trials and community SC reports | Route-specific evidence differs |
| Route conversion | Not established | Oral and SC amounts are not interchangeable |
AOD-9604 Dosage Chart
| Route | Amount | Frequency | Source | Human validation |
|---|---|---|---|---|
| Oral trial | 0.25 mg | Daily for 24 weeks | Human Phase 2b | Yes, trial design only |
| Oral trial | 0.5 mg | Daily for 24 weeks | Human Phase 2b | Yes, trial design only |
| Oral trial | 1 mg | Daily for 24 weeks | Human Phase 2b | Yes, trial design only |
| Subcutaneous | 300 mcg | Once daily | Community report | No |
| Subcutaneous | 500 mcg | Once daily | Community report | No |
Published study values describe those studies. Community-reported values are not validated dosing recommendations.
AOD-9604 Reconstitution Guide
Concentration: 1 mg/mL
| Entered amount | Volume | U-100 units |
|---|---|---|
| 0.3 mg | 0.3 mL | 30 units |
| 0.6 mg | 0.6 mL | 60 units |
| 0.9 mg | 0.9 mL | 90 units |
- 1.Confirm the vial quantity.
- 2.Record the selected diluent volume.
- 3.Clean the stopper.
- 4.Add liquid slowly along the vial wall.
- 5.Swirl gently; do not shake.
- 6.Inspect the solution.
- 7.Label the concentration and preparation date.
- 8.Use the calculator result only as arithmetic.
Reconstitution does not establish identity, purity, sterility, stability, or an appropriate amount.
How AOD-9604 Works
Peptide fragment
AOD-9604 corresponds to a modified C-terminal region of human growth hormone.
AOD-9604 Human Trials and FDA Status
Current status · verified September 15, 2026
Not FDA approved
- Approximately 900 participants were reported across the development program.
- The 24-week METAOD006/OPTIONS study tested oral 0.25, 0.5, and 1 mg daily and did not meet the primary weight-loss endpoint.
- No published human SC pharmacokinetic study was identified.
- The FDA reviewed AOD-9604 for compounding-list considerations in December 2024; it is not FDA approved.
- Food-ingredient GRAS status is not drug approval.
Who Should Avoid AOD-9604?
This is an evidence-gap and precaution list, not an approved prescribing label.
Pregnancy or breastfeeding
No established safety
Children or adolescents
No established protocol
Active or recent cancer
Nonclinical signals require caution
Significant liver disease
Nonclinical liver findings were reviewed by FDA
Bone-turnover disorders
Nonclinical osteocalcin findings require caution
Tested athletes
Check the current WADA prohibited list
AOD-9604 Side Effects, Risks and Safety
Headache, fatigue, or dizzinessHuman trial reported
Important limitation: Frequency and route context vary.
Gastrointestinal symptomsHuman trial reported
Important limitation: Includes diarrhea, flatulence, and nausea.
Injection-site effectsNot established
Important limitation: No adequate human SC safety dataset.
Liver findingsNonclinical signal
Important limitation: Monkey periportal hepatocyte vacuolation.
Bone-turnover findingsNonclinical signal
Important limitation: Rat osteocalcin changes.
Impurities and aggregatesFDA concern
Important limitation: Injectable product quality can alter risk.
Long-term effectsNot established
Important limitation: Development data are limited.
AOD-9604 Timeline and Monitoring
24 weeks
Pivotal oral Phase 2b period; primary endpoint was not met.
Subcutaneous timeline
Not established; community schedules are not clinical timelines.
Monitoring
No validated SC monitoring panel or stopping rule exists.
AOD-9604 Benefits and Results: What the Evidence Shows
| Claim | Evidence level | What research shows | Important limitation |
|---|---|---|---|
| Human weight loss | Not established | Phase 2b did not beat placebo on the primary endpoint | No approved indication |
| Lipolysis | Preclinical | Mouse research reported pathway effects | Does not establish human fat loss |
| Cartilage research | Preclinical | Rabbit joint research exists | No established human benefit |
| Growth effects | Not established as a benefit | Designed to avoid full hGH effects | Mechanism remains incomplete |
AOD-9604 Storage and Handling
Unreconstituted vial
No independently verified AOD-9604 vial stability duration was identified.
Prepared vial
No validated compound-specific refrigerated-use duration was identified.
Oral trial material
Trial-product handling does not establish handling for current commercial vials.
Appearance
Cloudiness, discoloration, or particles require qualified product review.
AOD-9604 Troubleshooting
Calculator differs from a label
Confirm mg, mL, target unit, and U-100 scale.
Oral and SC amounts conflict
The routes are not interchangeable.
Solution looks abnormal
Do not assume it is usable; seek qualified product guidance.
Expected weight change does not occur
The pivotal obesity study did not establish efficacy.
A scheduled amount is missed
No validated SC missed-amount procedure exists.
AOD-9604 Comparisons
| Compound | Class or mechanism | Evidence | FDA status |
|---|---|---|---|
| AOD-9604 | Modified hGH fragment | Human oral trials; SC community reports | Not approved |
| HGH fragment 176–191 | Related fragment naming | Not automatically identical to every AOD-9604 product | Not approved |
| Full-length hGH | Growth hormone receptor agonist | Approved for specific indications | Not interchangeable |
| GLP-1 medicines | Incretin pathway | Controlled human efficacy for approved indications | Different mechanism |
AOD-9604 Frequently Asked Questions
What is AOD-9604?
A modified fragment of the C-terminal region of human growth hormone.
Is it FDA approved?
No.
Did human trials show weight loss?
The pivotal 24-week oral study did not meet its primary endpoint.
Is the SC schedule clinically validated?
No.
What is its SC half-life?
Not established.
Are oral and SC amounts interchangeable?
No.
Does GRAS status mean drug approval?
No.
What does the calculator establish?
Only concentration and volume arithmetic.
Is there a validated rest period?
No.
Is long-term injectable safety known?
No adequate human SC dataset was identified.
Sources and Research
Coverage source
1. AOD-9604 protocol coverage source
Community schedule and page coverage; not primary evidence.
Open direct sourceRegulatory
2. FDA Pharmacy Compounding Advisory Committee briefing
Official 2024 review of identity, clinical development, nonclinical findings, and product-quality concerns.
Open direct sourceAnimal research
3. The effects of human GH and its lipolytic fragment (AOD9604) on lipid metabolism
Mouse beta-3 adrenergic receptor research.
Open direct sourceHuman research
4. Safety and tolerability of AOD9604 in humans
Development-program review; interpret alongside the failed pivotal efficacy endpoint.
Open direct sourceMissing information flagged for review
- Validated human SC dose: Not established
- Human SC pharmacokinetics and half-life: Not established
- SC cycle and rest period: Not established
- Compound-specific vial stability: Not established
- Long-term injectable safety: Not established
- Validated SC monitoring protocol: Not established