Safety and Benefit of MBX-8025 With and Without Commonly Used Statins in Moderately Overweight Patients With High Cholesterol

Completed · Phase 2 · Has a placebo group

Conditions studied: Hyperlipidemia

In brief

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.

Key facts

Study ID

NCT00701883

Run by

Gilead Sciences

People needed

183

Starts

2007-08-01

Expected to finish

2008-08-01

Last updated by the study team

2015-06-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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