Safety and Benefit of MBX-8025 With and Without Commonly Used Statins in Moderately Overweight Patients With High Cholesterol
NCT ID: NCT00701883
Last Updated: 2015-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
183 participants
INTERVENTIONAL
2007-08-31
2008-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo/Placebo
Placebo
2 capsules, once a day for 8 weeks
MBX-8025 50 mg/Placebo
Placebo
2 capsules, once a day for 8 weeks
MBX-8025
2 capsules, once daily for 8 weeks
MBX-8025 100 mg/Placebo
Placebo
2 capsules, once a day for 8 weeks
MBX-8025
2 capsule, once daily for 8 weeks
Placebo/Atorvastatin 20 mg
Placebo
2 capsules, once a day for 8 weeks
Atorvastatin
2 capsules, once daily for 8 weeks
MBX-8025 50 mg/Atorvastatin 20 mg
Atorvastatin
2 capsules, once daily for 8 weeks
MBX-8025
2 capsules, once daily for 8 weeks
MBX-8025 100 mg/Atorvastatin 20 mg
Atorvastatin
2 capsules, once daily for 8 weeks
MBX-8025
2 capsules, once daily for 8 weeks
Interventions
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Placebo
2 capsules, once a day for 8 weeks
MBX-8025
2 capsules, once daily for 8 weeks
MBX-8025
2 capsule, once daily for 8 weeks
Atorvastatin
2 capsules, once daily for 8 weeks
MBX-8025
2 capsules, once daily for 8 weeks
MBX-8025
2 capsules, once daily for 8 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Brian Roberts, M.D.
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Radiant Research
Birmingham, Alabama, United States
Anasazi Internal Medicine Research
Phoenix, Arizona, United States
Diabetes/Lipid Management and Research Center
Huntington Beach, California, United States
Radiant Research
Santa Rosa, California, United States
Clinical Research Consulting LLC
Milford, Connecticut, United States
Genesis Research International
Indianapolis, Indiana, United States
Midwest Institute for Clinical Research Inc.
Indianapolis, Indiana, United States
L-Marc Research Center
Louisville, Kentucky, United States
Maine Research Associates
Auburn, Maine, United States
Health Trends Research LLC
Baltimore, Maryland, United States
Troy Internal Medicine Research
Troy, Michigan, United States
Bridgewater Medical Group
Bridgewater, New Jersey, United States
Clifton-Wallington Medical Group
Clifton, New Jersey, United States
Rochester Clinical Research
Albuquerque, New Mexico, United States
United Medical Associates P.C.
Binghamton, New York, United States
Rochester Clinical Research
Rochester, New York, United States
Southgate Medical Group
West Seneca, New York, United States
Great Lakes Medical Research
Westfield, New York, United States
PharmQuest
Greensboro, North Carolina, United States
Crescent Medical Research
Salisbury, North Carolina, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States
PHA-Adult Medicine
Philadelphia, Pennsylvania, United States
Radiant Research
Greer, South Carolina, United States
Tricities Medical Research
Bristol, Tennessee, United States
Holston Medical Group Clinical Research
Kingsport, Tennessee, United States
Dallas Diabetes and Endocrine Center
Dallas, Texas, United States
Diabetes and Glandular Disease Research
San Antonio, Texas, United States
Walla Walla Clinic
Walla Walla, Washington, United States
Countries
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References
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Choi YJ, Roberts BK, Wang X, Geaney JC, Naim S, Wojnoonski K, Karpf DB, Krauss RM. Effects of the PPAR-delta agonist MBX-8025 on atherogenic dyslipidemia. Atherosclerosis. 2012 Feb;220(2):470-6. doi: 10.1016/j.atherosclerosis.2011.10.029. Epub 2011 Nov 16.
Bays HE, Schwartz S, Littlejohn T 3rd, Kerzner B, Krauss RM, Karpf DB, Choi YJ, Wang X, Naim S, Roberts BK. MBX-8025, a novel peroxisome proliferator receptor-delta agonist: lipid and other metabolic effects in dyslipidemic overweight patients treated with and without atorvastatin. J Clin Endocrinol Metab. 2011 Sep;96(9):2889-97. doi: 10.1210/jc.2011-1061. Epub 2011 Jul 13.
Other Identifiers
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M8025-20711
Identifier Type: -
Identifier Source: secondary_id
70,961
Identifier Type: -
Identifier Source: org_study_id
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