Vivus has initiated the second of two pivotal phase III studies of its investigational drug, Qnexa, in overweight and obese patients with co-morbidities including hypertension, dyslipidemia or type 2 diabetes.
The CONQUER study will enroll patients with a body mass index (BMI) from 27 to 45, including patients with type 2 diabetes regardless of BMI. The primary endpoints will evaluate the differences between treatments from baseline to the end of the treatment period, in mean percent weight loss and in the percentage of participants, who achieve a weight loss of 5 percent or more.
The Mountain View, Calif.-based Vivus said the study will enroll approximately 2,500 subjects in up to 120 centers. Patients will 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 (7.5 mg), full strength Qnexa (15mg) or placebo.
Vivus said it has completed the Special Protocol Assessment (SPA) process for the trial with the FDA. Under the SPA process, Vivus and the agency have reached an agreement on study design features to be employed in the phase III trial.