Safety and Benefit of MBX-8025 With and Without Commonly Used Statins in Moderately Overweight Patients With High Cholesterol
Public ClinicalTrials.gov record NCT00701883. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Multicenter Randomized Double-Blind Placebo and Active Comparator Controlled Parallel-group, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of MBX-8025 in Moderately Obese Hyperlipidemic Patients With/Out Concomitant Atorvastatin"
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00701883
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 183 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2007 (Type not available)
- Primary completion
- Aug 2008 (Actual)
- Completion
- Aug 2008 (Actual)
- Last update posted
- Jun 12, 2015
2007 – 2008
United States locations
- U.S. sites
- 28
- U.S. states
- 18
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Radiant Research | Birmingham | Alabama | 35209 | — |
| Anasazi Internal Medicine Research | Phoenix | Arizona | 85032 | — |
| Diabetes/Lipid Management and Research Center | Huntington Beach | California | 92648 | — |
| Radiant Research | Santa Rosa | California | 95405 | — |
| Clinical Research Consulting LLC | Milford | Connecticut | 06460 | — |
| Genesis Research International | Indianapolis | Indiana | 46260 | — |
| Midwest Institute for Clinical Research Inc. | Indianapolis | Indiana | 46260 | — |
| L-Marc Research Center | Louisville | Kentucky | 40213 | — |
| Maine Research Associates | Auburn | Maine | 46260 | — |
| Health Trends Research LLC | Baltimore | Maryland | 21209 | — |
| Troy Internal Medicine Research | Troy | Michigan | 48098 | — |
| Bridgewater Medical Group | Bridgewater | New Jersey | 08807 | — |
| Clifton-Wallington Medical Group | Clifton | New Jersey | 07013 | — |
| Rochester Clinical Research | Albuquerque | New Mexico | 87108 | — |
| United Medical Associates P.C. | Binghamton | New York | 13901 | — |
| Rochester Clinical Research | Rochester | New York | 14609 | — |
| Southgate Medical Group | West Seneca | New York | 14224 | — |
| Great Lakes Medical Research | Westfield | New York | 14787 | — |
| PharmQuest | Greensboro | North Carolina | 27401 | — |
| Crescent Medical Research | Salisbury | North Carolina | 28144 | — |
| Piedmont Medical Research Associates | Winston-Salem | North Carolina | 27103 | — |
| PHA-Adult Medicine | Philadelphia | Pennsylvania | 19146 | — |
| Radiant Research | Greer | South Carolina | 29651 | — |
| Tricities Medical Research | Bristol | Tennessee | 37620 | — |
| Holston Medical Group Clinical Research | Kingsport | Tennessee | 37660 | — |
| Dallas Diabetes and Endocrine Center | Dallas | Texas | 75230 | — |
| Diabetes and Glandular Disease Research | San Antonio | Texas | 78229 | — |
| Walla Walla Clinic | Walla Walla | Washington | 99362 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00701883, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 12, 2015 · Synced Oct 28, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00701883 live on ClinicalTrials.gov.