FDAnews
www.fdanews.com/articles/101272-atherogenics-drops-highest-dose-in-diabetes-drug-trial

AtheroGenics Drops Highest Dose in Diabetes Drug Trial

November 19, 2007

The highest dose arm in a clinical trial of the investigational diabetes drug AGI-1067 has been halted due to liver toxicity.

AtheroGenics said it decided to discontinue the 300-mg dose of its lead investigational compound, AGI-1067, after reviewing evidence of  “the rare occurrence of adverse effects on the liver” from a previous Phase III trial of the drug and discussing these data with the FDA. The 75-mg and 150-mg dose arms of the current dose-ranging study of the drug will continue.

AtheroGenics said it hopes to complete enrollment in the remaining arms of the trial by the end of the year. Interim analysis of the study’s primary endpoint is scheduled for the second quarter of 2008.