"AOD9604 Update 12 Week Follow-Up Data Show Weight Loss Maintained in Trial Volunteers 20 April 2005 •
An unexpected outcome from the clinical trial was the way the patients responded to AOD9604 at different doses. These data have now been further analysed with emphasis on the data relating to gender effects on weight, waistline and the different fat compartments. New data from subsequent investigations in the Metabolic laboratories have also now been analysed. The trial showed that the best effect was seen at the lowest daily dose tried, 1 mg, but the effect was less at doses around 10 mg and tended to return athigher doses (see appendix). The trial data also indicate that men andwomen respond similarly at 1 mg, while at high doses, the effect is greater in men (see appendix).This difference in dose response between men and women is believed to be related to the different balance of fat distribution in men and women, with different effects indicated in the clinical trial data on distinct fat compartments.The “bimodal” pattern of low dose and high dose activity has recently beenreplicated in laboratory in vitro tests showing drug activity at unexpectedly low concentrations as well as at high concentrations, but less or none at intermediate concentrations. This has been seen in both cultured fat cells and in cultured fat tissue. Both the clinical trial and the laboratory tests support the exploration of doses below and around 1 mg in the next study, to be conducted before Phase 3, tofind an optimum daily dose for overall weight loss in both men and women, and to clarify the effects on fat compartments.
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