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news.Vivus has completed enrollment in the first of two pivotal Phase III studies of Qnexa in obese patients.
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The Equip study (OB-302) has enrolled over 1,250 morbidly obese patients with a body mass index (BMI) that equals or exceeds 35. The co-primary endpoints for these studies are the mean percent weight loss and the percentage of subjects achieving weight loss of 5% or more.
Leland Wilson, president and CEO of Vivus, said: “The completion of enrollment in approximately four months represents an outstanding effort by our clinical development team and our CRO, Medpace.
“The Equip study will evaluate the effect of Qnexa on morbidly obese patients who meet the BMI criteria for gastric bypass surgery. Completing enrollment ahead of schedule illustrates the large interest, driven by need, for an effective oral medication to treat obesity. We anticipate that the results of the study will be available in the second half of 2009.”