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NCT00701883 · ClinicalTrials.gov registry record · Phase 2
Safety and Benefit of MBX-8025 With and Without Commonly Used Statins in Moderately Overweight Patients With High Cholesterol
A Phase 2 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 183
- Enrollment target
NCT00701883 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 183 participants.
The verdict
NCT00701883, a Phase 2 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 183 participants
- Enrollment target
Study Summary
A Multicenter Randomized, Double-Blind, Placebo-Controlled Study to evaluate the efficacy, safety and tolerability of MBX-8025, a novel PPAR-d agonist to treat hyperlipidemia, insulin resistance and obesity in overweight, hyperlipidemic patients, both as monotherapy and in combination with Atorvastatin Total participation for each patient is approximately 16-17 weeks, which may include up to a 2 week screening period, 5 week run-in period, 8 week treatment period, and 2 week follow-up. During the run-in period patients taking statins, statin combination or Zetia will undergo a 'washout'. All patients will be instructed to follow a weight-maintenance diet (i.e., their same diet prior to entering the study). They will be asked to defer initiating any weight loss diets or meaningful changes in their activity level until after they have completed the study. Once randomized into the double blind study, patients will visit the clinic every two weeks thereafter until the end of the study. At the end of the 8-week treatment phase, the double-blind study medication will be discontinued. Patients will attend a follow up visit two weeks after their final dose for safety evaluation.
Interventions
- DRUG Placebo
- DRUG Atorvastatin
- DRUG MBX-8025
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2007-08 |
| Est. Completion | 2008-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00701883
The ClinicalTrials.gov registry entry for NCT00701883 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 183 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00701883 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00701883 about?
NCT00701883 is a clinical study titled "Safety and Benefit of MBX-8025 With and Without Commonly Used Statins in Moderately Overweight Patients With High Cholesterol". A Multicenter Randomized, Double-Blind, Placebo-Controlled Study to evaluate the efficacy, safety and tolerability of MBX-8025, a novel PPAR-d agonist to treat hyperlipidemia, insulin resistance and obesity in overweight, hyperlipidemic patients, both as monotherapy and in combination with Atorvasta...
What is the current status of trial NCT00701883?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 183 participants. The study started on 2007-08. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00701883?
The interventions under investigation include: Placebo (DRUG), Atorvastatin (DRUG), MBX-8025 (DRUG).
Who is sponsoring clinical trial NCT00701883?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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