drugset / Trial / NCT00115063

LOSS- Louisiana Obese Subjects Study

NCT00115063

RandomizedParallel-groupOpen-labelTreatment

Summary

LOSS is a pragmatic clinical evaluation of intensive medical approaches to weight loss for individuals with extreme obesity (body mass index \[BMI\] 40-60 kg/m2). The intensive medical treatment is designed to produce 25% weight loss from baseline and to maintain at least 20% weight loss from baseline. The intensive medical treatment is compared to a usual care treatment model where individuals utilize self directed approaches to weight loss. The active treatment period is three years, followed by two years of observation.

Timeline

Start
2005-07
Primary completion
2007-12
Completion
2008-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Orlistat Small molecule
Subject Sibutramine Small molecule
Subject diethylpropion Small molecule

Indications