Safety and Benefit of MBX-8025 With and Without Commonly Used Statins in Moderately Overweight Patients With High Cholesterol
- Registration Number
- NCT00701883
- Lead Sponsor
- CymaBay Therapeutics, Inc.
- 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 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.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 183
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo/Atorvastatin 20 mg Placebo - Placebo/Placebo Placebo - MBX-8025 50 mg/Placebo Placebo - MBX-8025 100 mg/Placebo Placebo - MBX-8025 50 mg/Placebo MBX-8025 - MBX-8025 50 mg/Atorvastatin 20 mg MBX-8025 - MBX-8025 100 mg/Atorvastatin 20 mg MBX-8025 - MBX-8025 100 mg/Placebo MBX-8025 - Placebo/Atorvastatin 20 mg Atorvastatin - MBX-8025 50 mg/Atorvastatin 20 mg Atorvastatin - MBX-8025 100 mg/Atorvastatin 20 mg Atorvastatin -
- Primary Outcome Measures
Name Time Method Lipid levels will be measured in patients with hyperlipidemia to assess the benefits of the investigational drug 8 week treatment period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
Dallas Diabetes and Endocrine Center
🇺🇸Dallas, Texas, United States
Diabetes/Lipid Management and Research Center
🇺🇸Huntington Beach, California, 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
Health Trends Research LLC
🇺🇸Baltimore, Maryland, United States
Troy Internal Medicine Research
🇺🇸Troy, Michigan, United States
Great Lakes Medical Research
🇺🇸Westfield, New York, United States
Rochester Clinical Research
🇺🇸Rochester, New York, United States
Southgate Medical Group
🇺🇸West Seneca, New York, United States
United Medical Associates P.C.
🇺🇸Binghamton, 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
Walla Walla Clinic
🇺🇸Walla Walla, Washington, United States
Holston Medical Group Clinical Research
🇺🇸Kingsport, Tennessee, United States
Diabetes and Glandular Disease Research
🇺🇸San Antonio, Texas, United States
Clinical Research Consulting LLC
🇺🇸Milford, Connecticut, United States
Bridgewater Medical Group
🇺🇸Bridgewater, New Jersey, United States
Clifton-Wallington Medical Group
🇺🇸Clifton, New Jersey, United States
Anasazi Internal Medicine Research
🇺🇸Phoenix, Arizona, United States
Maine Research Associates
🇺🇸Auburn, Maine, United States
Tricities Medical Research
🇺🇸Bristol, Tennessee, United States
Radiant Research
🇺🇸Greer, South Carolina, United States