Study record · AOD-9604
FDA-reviewed 12-week oral AOD-9604 obesity study
FDA review notes only small between-group differences with unclear clinical importance and limited published detail.
Key result
FDA review notes only small between-group differences with unclear clinical importance and limited published detail.
Study details
Study designRandomized double-blind placebo-controlled dose-ranging study
PopulationAdults with obesity
Sample size300
RouteOral
Regimen / exposure1, 5, 10, 20 or 30 mg/day
Duration12 weeks
ComparatorPlacebo
Primary endpoint / questionBody-weight change
Safety resultAdverse-event interpretation was limited by available reporting.
Key limitationsEvidence was largely available through development abstracts/regulatory review rather than a full modern publication.
Registry / identifierFDA PCAC evidence review