Manhattan Pharmaceuticals Completes Dosing Portion Of Two Phase 2a Clinical Trials Of Oral Oleoyl-Estrone For Obesity
Oral Oleoyl-Estrone For Obesity
Manhattan Pharmaceuticals announced it has successfully completed patient dosing in two separate, ongoing Phase 2a clinical trials of oral Oleoyl-estrone.
The first trial is evaluating OE for the treatment of common obesity and the second trial is evaluating OE for treatment of morbid obesity. Both trials include a post-dosing follow up period. Study completion and data analysis will begin after the final follow up visit. Data analysis is scheduled to be completed in July 2007.
The common obesity clinical trial is a multi-center, international, randomized, double-blind, placebo-controlled, parallel group study of OE in 100 patients. This study is designed to evaluate obese adult subjects with a body mass index (BMI) of 27-38.9. The subjects were randomized into one of four treatment groups to evaluate the safety, preliminary efficacy, and pharmacokinetics of two 14-day dosing cycles of 5mg, 10mg, or 20mg of oral OE compared to placebo given once daily during each dosing cycle. The dosing cycles are each followed by a 28-day treatment free evaluation period, and then a final follow-up visit takes place at Day 113, 57 days after administrations of the final dose.