Study record · AOD-9604
OPTIONS obesity trial reviewed by FDA
FDA review reports no statistically significant difference in weight loss between AOD-9604 and placebo.
Key result
FDA review reports no statistically significant difference in weight loss between AOD-9604 and placebo.
Study details
Study designRandomized double-blind placebo-controlled trial
PopulationAdults with obesity
Sample size502
RouteOral
Regimen / exposure0.25, 0.5 or 1 mg/day plus diet/exercise
Duration24 weeks
ComparatorPlacebo plus diet/exercise
Primary endpoint / questionWeight loss
Safety resultSerious adverse events were reported across the development programme; causality for individual events was uncertain.
Key limitationsLargest identified obesity trial was negative; results were not a full peer-reviewed modern publication.
Registry / identifierFDA PCAC evidence review / OPTIONS