phase 2b RCT2007
The OPTIONS phase 2b trial (about 500 adults with obesity; FDA cites 502) of oral AOD-9604 for 24 weeks with diet and exercise found no significant difference in weight loss vs placebo, and Metabolic Pharmaceuticals ended obesity development in 2007.
about 500 adults with obesity (FDA: 502), phase 2b, 24 weeks
pooled safety data, sponsor-funded2013
In sponsor-funded safety data from six placebo-controlled IV and oral studies (Stier et al. 2013, summarized by FDA), AOD-9604 did not change serum IGF-1 vs placebo, and no anti-AOD-9604 antibodies were detected with up to 24 weeks of oral use.
participants in six placebo-controlled IV/oral studies
phase 2b RCT, abstract only2004
In a 12-week phase 2b trial, 300 adults with obesity took oral AOD-9604 (five dose arms) or placebo; the sponsor announced that the best-performing arm lost 2.8 kg vs 0.8 kg on placebo. FDA later noted the result rests on small between-group differences reported only in an abstract.
300 adults with obesity, phase 2b
regulatory2024
FDA removed AOD-9604 from Category 2 of its interim 503A policy in September 2024 after the nominators withdrew, then evaluated it on its own initiative; on Dec 4, 2024 the Pharmacy Compounding Advisory Committee voted 12-0 against placing AOD-9604 (free base and acetate) on the 503A Bulks List.
n/a - regulatory
anti-doping rule2026
AOD-9604 is explicitly named as an example substance under WADA's S2 category (Growth Hormone fragments), making it prohibited in and out of competition.
n/a - regulatory/anti-doping