Status:
COMPLETED
Safety and Benefit of MBX-8025 With and Without Commonly Used Statins in Moderately Overweight Patients With High Cholesterol
Lead Sponsor:
Gilead Sciences
Conditions:
Hyperlipidemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 o...
Detailed Description
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 ru...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age: 18-75 years
- Female patients must not be pregnant or breast-feeding
- Patients must be moderately overweight
- All patients must have abnormal cholesterol levels or a history of abnormal cholesterol levels as defined by the protocol.
- Patients taking medication to lower their cholesterol must be willing, in some cases, to discontinue their medications during the study Stable weight (a history of increasing or decreasing no more than 6.6 lbs \[3 kg\]) for at least 2 months prior to the study;
- Exclusion Criteria
- Cancer or a history of a cancer within 5 years before screening, other than some skin cancers
- Patients planning elective surgery during the study
- Patients with a history of diabetes mellitus at study onset
- History of intolerance to, or adverse effect from atorvastatin
- History of weight loss due to stomach bypass or eating disorder
- All patients may not have had a stroke, TIA, an acute myocardial infarction, angina pectoris, coronary intervention procedure (including but not limited to angioplasty, stent placement, coronary revascularization) lower extremity bypass procedure, systemic or intracoronary fibrinolytic therapy) within 5 months of screening
Exclusion
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT00701883
Start Date
August 1 2007
End Date
August 1 2008
Last Update
June 12 2015
Active Locations (28)
Enter a location and click search to find clinical trials sorted by distance.
1
Radiant Research
Birmingham, Alabama, United States, 35209
2
Anasazi Internal Medicine Research
Phoenix, Arizona, United States, 85032
3
Diabetes/Lipid Management and Research Center
Huntington Beach, California, United States, 92648
4
Radiant Research
Santa Rosa, California, United States, 95405