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news.Vivus has agreed on key elements of a Phase III trial of Qnexa for the treatment of obesity and weight-related co-morbidities with the FDA, under the special protocol assessment process.
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The Phase III Qnexa program will include two pivotal, double-blind, placebo-controlled, multi-center studies in distinct populations that will compare Qnexa to placebo during a 56-week treatment period. The studies are designed to proactively demonstrate the safety of Qnexa.
The first study, known as Equip (OB-302), will enroll morbidly obese adult subjects with a body mass index (BMI) of 35 or greater with controlled co-morbidities. The second trial, known as Conquer (OB-303), will enroll overweight and obese adult subjects with BMIs from 27 to 45 and at least two co-morbid conditions, such as hypertension, dyslipidemia and type 2 diabetes.
The co-primary endpoints for these studies will evaluate the differences between treatments in mean percent weight loss from baseline to the end of the treatment period, and the differences between treatments in the percentage of subjects achieving weight loss of 5% or more.
The Phase III program will also include a six-month confirmatory factorial study, known as Equate (OB-301), in obese subjects with BMIs from 30 to 45. This trial will evaluate two dose levels of Qnexa, compared to both placebo and the individual constituents of the combination. The primary endpoints will be similar to those evaluated in the pivotal studies. The Phase III studies will enroll approximately 4,500 subjects.