Distinct protocol, timing or sequence preserved from the saved research material. Unreported fields remain unknown.
Context: Human · Adults with obesity; 536 enrolled, 502 randomized; diet-and-exercise program
Human study regimen: Amount: 0.25, 0.5 or 1 mg; Frequency: Once daily; Duration: 24 weeks plus a 4-week run-in; Route: Oral; Species: Human; Population: Adults with obesity; 536 enrolled, 502 randomized; diet-and-exercise program
Limitations: OPTIONS Phase 2B (company announcement, 21 February 2007): oral AOD-9604 tablets at 0.25, 0.5, or 1 mg once daily versus placebo after a four-week diet-and-exercise run-in, followed by 24 weeks of treatment. No dose demonstrated statistically significant additional weight loss versus placebo at 12 or 24 weeks; the developer discontinued its obesity program. Company disclosure, not a peer-reviewed full trial report. Human pharmacokinetic results were not provided in the announcement. Historical study doses are not treatment recommendations. Oral tablet findings do not establish sublingual-troche absorption, efficacy, or fasting-time benefit.