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news.Vivus has completed enrollment in the final of three Phase III studies of Qnexa in overweight and obese patients with co-morbidities including hypertension, dyslipidemia, or type 2 diabetes.
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The Conquer study (OB-303) enrolled patients with a body mass index (BMI) ranging from 27 to 45 and at least two additional co-morbidities. The co-primary endpoints for this study are the mean percent weight loss and the percentage of subjects achieving weight loss of 5% or more.
In the Conquer study, approximately 2,500 subjects will be treated at approximately 93 centers throughout the US. Patients undergo a four-week dose escalation period followed by 52 weeks of treatment. The study is a randomized, double blind, placebo-controlled prospective trial with subjects randomized to receive once-a-day treatment with mid-dose Qnexa (7.5mg phentermine/46mg topiramate CR), full strength Qnexa (15mg phentermine/92mg topiramate CR) or placebo.
Leland Wilson, president and CEO at Vivus, said: “Our Phase III program is designed to evaluate weight loss in these patients and potential benefit on their co-morbidities. Completing enrollment for a 4,500-patient Phase III program ahead of schedule is a major accomplishment for our development team at Vivus. We are now poised to complete these studies by the middle of 2009.”