The US-based pharmaceutical company said that the common obesity clinical trial will look at the effects of Oleoyl-estrone (OE) in 100 patients with a body mass index (BMI) of 27-38.9, while the morbid obesity trial will monitor the drug’s effects on 24 male subjects that are morbidly obese, with a BMI of 40-55.
In addition to safety and tolerability, both phase IIa studies are also designed to evaluate weight loss, maintenance of weight loss, and other therapeutic outcomes, the company said. Data analysis is scheduled to be completed in July 2007.
Manhattan said that there are currently no effective oral therapies available for the treatment of morbid obesity. The company hopes that OE, which is an orally administered, synthetic form of oleoyl-estrone, a molecule that exists naturally in the body, will prove effective.