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Human evidence record · AOD-9604

OPTIONS obesity trial reviewed by FDA

FDA review reports no statistically significant difference in weight loss between AOD-9604 and placebo.

Quick read
Human evidence record

What this study tells us

Participants were assigned to comparison groups by chance, usually with placebo and/or blinding to reduce bias. This is a strong design for testing cause and effect, but the population, duration and endpoints still limit what can be concluded.

Who was studied?

Adults with obesity

How many?

n=502

What happened?

FDA review reports no statistically significant difference in weight loss between AOD-9604 and placebo.

What stops us overclaiming?

Largest identified obesity trial was negative; results were not a full peer-reviewed modern publication.

Need help with terms such as randomized, placebo, endpoint or sample size? Open the glossary →

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
Open AOD-9604 page →Open primary source →