Evidence Grade C — Moderate human evidence. 11 published studies, 10 human. 0 registered clinical trials.
Medically reviewed by a licensed medical professional
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.
AOD-9604 is also known by these brand and alternate names:
11 published studies: 10 human, 0 animal, 0 in-vitro, 5 reviews
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.
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 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.
PeptideTrace tracks 0 registered clinical trials for AOD-9604 sourced from ClinicalTrials.gov.
No trials registered on ClinicalTrials.gov for this compound.
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.
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.
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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CT-388 is in Phase II/III development (not yet approved). Phase II results (469 patients, 48 weeks) showed 22.5% placebo-adjusted weight loss at the highest dose, with low discontinuation rates due to adverse events (5.9%). Phase III trials are underway. The combination of high efficacy and low discontinuation rates in Phase II is notable — many obesity drugs achieve high weight loss but suffer from tolerability-driven dropouts. Roche's $2.7 billion acquisition of the developer signals significant confidence in the programme.
Evidence Reviews
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.
