Manhattan Pharmaceuticals has commenced dosing the first group of patients in its Phase IIa clinical trial of oral Oleoyl-estrone (OE), the company's novel drug candidate for the treatment of obesity. Patient recruitment is ongoing.
The randomized, double-blind, placebo-controlled, parallel group Phase IIa study of OE is designed to evaluate the safety, preliminary efficacy, and pharmacokinetics of two 14-day cycles of escalating oral doses of the compound in obese adult subjects. Dose levels of OE will be placebo, 5, 10, and 20 mg daily. The company expects that 100 subjects will be randomly enrolled into one of these four treatment groups that comprise this Phase IIa trial.