NCT01351753

Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity

Does Reversal of Visceral Obesity by Drug Therapy Improve Vascular Function?

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Metabolic Syndrome X

Interventions

Type	Name	Description
DRUG	Metformin
DRUG	Orlistat
DRUG	Topiramate
DRUG	Placebo	Placebo pills and capsules for metformin, orlistat and topiramate

Timeline

• Start date: 2011-03-01
• Primary completion: 2014-01-09
• Completion: 2014-01-09
• First posted: 2011-05-11
• Last updated: 2026-03-12
• Results posted: 2021-06-09

Locations

1 site across 1 country: United States