Vivus closes enrollment in Equate obesity study

The Equate study has enrolled over 700 patients with body mass index ranging from 30 to 45 in 35 clinical sites. Patients in the Equate study will undergo a four-week dose titration period followed by 24 weeks of treatment. The co-primary endpoints for these studies will evaluate the differences between treatments in mean percent weight loss and in the percentage of subjects achieving weight loss of 5% or more.

VIVUS has also completed the special protocol assessment (SPA) process for this trial with the FDA. Under the SPA process, the company and the FDA have reached agreement on study design features that will be employed throughout the entire Phase III program including the co-primary endpoints of the study, scope and size of the patient population, specific safety assessments, inclusion or exclusion criteria, duration of the trials and the statistical method for analyzing the co-primary study endpoints.

Wesley Day, vice president of clinical development for Vivus, said: “The Equate study is one of the three studies in the Phase III obesity program. Completing enrollment ahead of schedule may allow us to present top-line results before the end of 2008.”