The aim of this timed, dose-ranging, randomized intervention is to determine the optimal dosage of Ergoset with respect to safety and efficacy in the treatment of clinical obesity. The primary objective is to evaluate weight loss in subjects treated with two different dosages of Ergoset plus a 25% hypocaloric diet when separately compared to a placebo control group on a 25% hypocaloric diet (see the Nutrition Manual for details). Secondary objectives will involve determining the impact of Ergoset on elevated levels of diurnal glucose, insulin, prolactin, and serum lipids; blood pressure; waist circumference; as well as incidence of adverse events.
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