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NCT01351753 · ClinicalTrials.gov registry record · Phase 2
Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity
A Phase 2 study, sponsored by University of Iowa.
- Terminated
- Registry status
- Phase 2
- Development phase
- 128
- Enrollment target
NCT01351753 is a Phase 2 study that was terminated before completion, run by University of Iowa. The registered enrollment target is 128 participants.
The verdict
NCT01351753, a Phase 2 study, was terminated before completion, sponsored by University of Iowa.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 128 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Metformin
- DRUG Orlistat
- DRUG Topiramate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2011-03 |
| Est. Completion | 2014-01-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01351753
The ClinicalTrials.gov registry entry for NCT01351753 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Iowa, which has 228 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01351753 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01351753 about?
NCT01351753 is a clinical study titled "Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity". 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. ...
What is the current status of trial NCT01351753?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 128 participants. The study started on 2011-03. Estimated completion is 2014-01-09.
What interventions are being tested in trial NCT01351753?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Orlistat (DRUG), Topiramate (DRUG).
Who is sponsoring clinical trial NCT01351753?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
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