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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: Clinical Trial Phase 2 study, sponsored by University of Iowa.
NCT01351753 is a Phase 2 study that was terminated before completion, run by University of Iowa. The registered enrollment target is 128 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Weight obtained in the fasting state on a gowned subject.
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 |
Why NCT01351753 stopped before completion
NCT01351753 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01351753 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01351753's enrollment target sits among peer trials
128 553rd of 2000 higher than 1,446 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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