Ergo Starts Weight Loss Trial With Ergoset

Ergo Science Corp has started enrolling patients in a trial of its newbromocriptine-based product, Ergoset, as a treatment for clinical obesity. The orally-active timed formulation of the dopamine agonist is already showing promise in the reduction of hyperlipidemia in patients with type II diabetes (Marketletter June 16).

The study will enroll around 400 obese subjects at 15 centers across the USA, and will evaluate the weight loss achieved with Ergoset at two doses (2.4mg/day and 4.8mg/day), taken in the morning, in conjunction with a calorie-restricted diet. Aside from weight loss, other endpoints include waist circumference, blood pressure and the effects on serum lipids and insulin.

Ergo says it hopes to identify the most appropriate dose for weight reduction, and if this is successful, the next stage will be to design large-scale pivotal trials to support a New Drug Application for the obesity indication.