Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity (NCT01351753) | Clinical Trial Compass
TerminatedPhase 2
Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity
Stopped: Lack of funding
United States128 participantsStarted 2011-03
Plain-language 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.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 40 to 75 years
* Male or postmenopausal female
* BMI ≥ 30 kg/m2
* One or more major cardiovascular (CV) risk factors (hypertension, dyslipidemia, impaired glucose tolerance OR metabolic syndrome)
Exclusion Criteria:
* Congestive heart failure
* Renal impairment
* History of bariatric surgery (i.e. lap-band, Roux-en-Y or biliopancreatic diversion)
* Type I diabetes mellitus
* Weight loss \> 10% in the past 6 months
* Recurrent nephrolithiasis
* Current treatment for seizure disorder
* Hepatic cirrhosis
* Current use of study medications
* Current use of oral estrogen
* History of smoking cessation in the past three months
* Current cholestasis or malabsorption syndrome
* Planned use of any herbal or over-the-counter supplements for weight loss
* History of allergic reactions to metformin, topiramate, orlistat or any of ingredients
* Medical conditions requiring continuous use of phosphodiesterase inhibitors and/or the inability to withhold phosphodiesterase inhibitors for 48 hours
* Participation in another clinical drug study within four weeks prior to this investigation.
* Participation in any other weight loss or rigorous exercise program.
* Any disease or condition that in the opinion of the investigator may interfere with completion of the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.