Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity
Status:
Terminated
Trial end date:
2014-01-09
Target enrollment:
Participant gender:
Summary
Obesity is common (>30% of US adults), contributes to substantial morbidity and mortality,
but is difficult to treat. Partly this is due to the transient, arduous and modest nature of
lifestyle interventions. Partly it is due to the limited efficacy and safety problems of
existing pharmacotherapy. Only one drug, orlistat, is approved for long-term use in obesity;
but its effects on weight are relatively small. There are drugs that have been approved for
other diseases but which also reduce weight. One promising approach to treating obesity is
combination therapy with orlistat and one or more of these other agents. The investigators
propose an innovative approach to developing new therapies for obesity coupling the use of
combination therapy with rigorous assessment of cardiovascular safety. Vascular function is a
quantitative surrogate clinical endpoint that has been strongly and independently linked to
future cardiovascular events.
Our hypothesis is that combination pharmacotherapy will reduce weight and improve vascular
function in obese human subjects. The co-primary endpoints will be weight and vascular
function.