Manhattan Pharmaceuticals has been granted Swiss regulatory approval to begin its Phase IIa study with oral Oleoyl-estrone (OE), the company's drug candidate for the treatment of obesity.
The single-center, Phase IIa study is a randomized, double-blind, placebo-controlled, parallel group study designed to evaluate the safety, preliminary efficacy, and pharmacokinetics of two 14-day dosing cycles in obese adult subjects. 100 subjects will be randomly enrolled in one of four treatment groups. Dose levels of OE will be placebo, 5, 10, or 20 mg taken once daily. Each 14-day dosing cycle will be followed by a 28-day treatment free evaluation period.