Metabolic begins fourth trial of obesity drug

Melbourne-based Metabolic Pharmaceuticals has begun a Phase IIA clinical trial for its obesity drug AOD9604 to investigate safety of daily dosing in preparation for the Phase IIB weight reduction study scheduled for next year.

The 36 healthy obese male volunteers will be divided into three groups and given a daily oral dose of either 9, 27 or 54 milligrams of AOD9604, with a week in between each dose group to assess safety and obtain permission to progress to the next dose level. Three patients in each group will receive a placebo instead of the drug. The trial is randomised and double-blinded.

Metabolic's managing director Dr Chris Belyea said that the dosing would be completed by the end of the year and results would probably be reported in February 2003, after analysis. He noted that the small study size meant that significant data about weight loss would not be expected, as the trial was designed purely to look at safety.

According to Belyea, the trial is a necessary regulatory requirement for the Phase IIB study, as none of the previous trials have looked at multiple dosing regimes.

The Phase IIB trial will involve 200 patients receiving daily doses of AOD9604 for three months, to determine whether clinically meaningful weight loss is achieved. Planning of the study is underway and is dependent on the completion of animal toxicology studies, said Belyea.

"At the moment what we're saying is second quarter next year," he said. The study will be a multi-centre trial and at the earliest, results would be announced at the end of 2003 or beginning of 2004. As with the other trials, healthy obese male volunteers will be selected.

The current trial is the fourth that Metabolic has performed on AOD9604, and the third trial this year. In August, the company announced that a single oral dose of the drug increased fat breakdown for several hours after administration and patients receiving the drug lost an average of 0.2 kilograms one week after dosing.