PeptideTrace
Research CompoundModified GH Fragment (Unregulated)Weight Management

AOD-9604 (Anti-Obesity Drug 9604)

C

Evidence Grade C — Moderate human evidence. 11 published studies, 10 human. 0 registered clinical trials.

11 studiesUSEUCA

Medically reviewed by a licensed medical professional

Overview

AOD-9604 is a modified fragment of human growth hormone that was investigated for obesity but failed a Phase IIb clinical trial. It received FDA GRAS status in 2014 as a food ingredient — this is not a drug approval and does not permit therapeutic claims. It is available through unregulated sources and is prohibited by WADA in sport.

Also Known As

AOD-9604 is also known by these brand and alternate names:

Research Activity

11studies
Human 10
Reviews 5

11 published studies: 10 human, 0 animal, 0 in-vitro, 5 reviews

Regulatory Status

US
Not approved by FDA(FDA)
EU
Not authorised by EMA(EMA)
CA
Not approved by Health Canada(Health Canada)

Legal Status

USNot applicable (not approved)
EUNot applicable (not authorised)
CANot applicable (not approved)

Summary

AOD-9604 has no pharmaceutical authorisation. A Phase IIb obesity trial (536 patients, 12 weeks) of oral AOD-9604 failed to demonstrate significant weight loss compared to placebo. The obesity development programme was discontinued. The developer subsequently pivoted to investigating intra-articular injection for osteoarthritis with preliminary Phase IIa data.

The FDA GRAS status (2014) applies exclusively to its use as a food ingredient and does not constitute pharmaceutical approval, authorise therapeutic claims, or establish safety for injectable use. Products available through unregulated channels lack pharmaceutical quality assurance.

Mechanism of Action

Research suggests a similar mechanism to HGH Fragment 176-191 — proposed fat metabolism effects through a non-growth-hormone-receptor pathway. Additional preclinical research has investigated potential effects on cartilage, but these observations are from animal and cell culture studies only. No mechanism has been validated through successful human clinical trials.

Research Summary

Research suggests the pivotal Phase IIb obesity trial (536 patients, 12 weeks) of oral AOD-9604 failed to demonstrate significant weight loss compared to placebo. The obesity development programme was discontinued. Subsequent research has pivoted to investigating intra-articular injection for osteoarthritis, with only preliminary Phase IIa data. The FDA GRAS status applies exclusively to use as a food ingredient and does not constitute drug approval, authorise therapeutic claims, or establish safety for injection. This distinction is frequently misrepresented in marketing from unregulated sources. Products from unregulated channels lack pharmaceutical quality assurance.

Clinical Trials

PeptideTrace tracks 0 registered clinical trials for AOD-9604 sourced from ClinicalTrials.gov.

No trials registered on ClinicalTrials.gov for this compound.

Scientific Detail

Overview (Scientific)

AOD-9604 is modified HGH Fragment 176-191 with Tyr at C-terminus and disulfide modification. MW ~1,815 Da. Developed by Metabolic Pharmaceuticals/CalzTech (Australia). GRAS status FDA 2014 as food ingredient (not drug). Not approved as pharmaceutical. WADA prohibited 2013.

Mechanism of Action (Scientific)

Research suggests lipolysis stimulation and lipogenesis inhibition via non-GH receptor mechanism. Proposed beta-3 adrenergic/HSL enhancement. Additional: cartilage repair activity (increased proteoglycan synthesis, reduced degradation in canine OA and chondrocyte studies). Fat-reduction and cartilage-repair activities proposed as independent mechanisms.

Summary (Scientific)

No pharmaceutical authorization. Phase IIb obesity (N=536, 12 weeks): oral AOD-9604 failed — weight loss 1.9 vs. 1.4 kg placebo (P=NS). Development discontinued for obesity. CalzTech pivoted to intra-articular OA with preliminary Phase IIa results. FDA GRAS 2014 as food ingredient.

The information on this page is provided for educational and research reference purposes only. This is not medical advice. Always consult a qualified healthcare professional before making any health-related decisions.

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This content is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional before making decisions about your health.