Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults

Phase 3 Completed 1267 enrolled VIVUS LLC Medpace, Inc. · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521 compared to placebo in treatment of obesity in an adult population with BMI ≥ 35.

Timeline

Start: 2007-11
Primary completion: 2009-05
Completion: 2009-05

Publications

Guo F, Garvey WT. Cardiometabolic Disease Staging Predicts Effectiveness of Weight-Loss Therapy to Prevent Type 2 Diabetes: Pooled Results From Phase III Clinical Trials Assessing Phentermine/Topiramate Extended Release. Diabetes Care. 2017 Jul;40(7):856-862. doi: 10.2337/dc17-0088. Epub 2017 Apr 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Phentermine	Small molecule	3.75 mg	Oral
Comparator	Phentermine	Small molecule	15 mg	Oral
Comparator	Topiramate	Small molecule	23 mg	Oral
Comparator	Topiramate	Small molecule	92 mg	Oral

Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults

Summary

Timeline

Publications

Drugs

Indications