The single center phase IIa study is a placebo-controlled, parallel group study designed to evaluate the safety, preliminary efficacy, and pharmacokinetics of two 14-day dosing cycles in obese adult subjects.
“This approval marks a significant achievement in the clinical development program with oral Oleoyl-estrone,” said Douglas Abel, Manhattan's CEO. “Given the encouraging early trial results and the large unmet medical need in obesity, we are very pleased to be able to proceed toward patient recruitment and enrollment.”
Results of phase I clinical trials with oral oleoyl-estrone (OE), reported in October 2005, showed the compound was well tolerated. Subjects in the phase Ib study experienced weight loss as well as beneficial changes in blood glucose and cholesterol levels. There was also evidence of OE offering the potential for sustained weight loss after dosing with OE stopped.