Safety and Benefit of MBX-8025 With and Without Commonly Used Statins in Moderately Overweight Patients With High Cholesterol
MBX-8025
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"
2 other identifiers
interventional
183
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2007
Shorter than P25 for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 17, 2008
CompletedFirst Posted
Study publicly available on registry
June 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedJune 12, 2015
May 1, 2015
1 year
June 17, 2008
May 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lipid levels will be measured in patients with hyperlipidemia to assess the benefits of the investigational drug
8 week treatment period
Study Arms (6)
Placebo/Placebo
PLACEBO COMPARATORMBX-8025 50 mg/Placebo
EXPERIMENTALMBX-8025 100 mg/Placebo
EXPERIMENTALPlacebo/Atorvastatin 20 mg
ACTIVE COMPARATORMBX-8025 50 mg/Atorvastatin 20 mg
EXPERIMENTALMBX-8025 100 mg/Atorvastatin 20 mg
EXPERIMENTALInterventions
2 capsules, once a day for 8 weeks
2 capsules, once daily for 8 weeks
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (28)
Radiant Research
Birmingham, Alabama, 35209, United States
Anasazi Internal Medicine Research
Phoenix, Arizona, 85032, United States
Diabetes/Lipid Management and Research Center
Huntington Beach, California, 92648, United States
Radiant Research
Santa Rosa, California, 95405, United States
Clinical Research Consulting LLC
Milford, Connecticut, 06460, United States
Genesis Research International
Indianapolis, Indiana, 46260, United States
Midwest Institute for Clinical Research Inc.
Indianapolis, Indiana, 46260, United States
L-Marc Research Center
Louisville, Kentucky, 40213, United States
Maine Research Associates
Auburn, Maine, 46260, United States
Health Trends Research LLC
Baltimore, Maryland, 21209, United States
Troy Internal Medicine Research
Troy, Michigan, 48098, United States
Bridgewater Medical Group
Bridgewater, New Jersey, 08807, United States
Clifton-Wallington Medical Group
Clifton, New Jersey, 07013, United States
Rochester Clinical Research
Albuquerque, New Mexico, 87108, United States
United Medical Associates P.C.
Binghamton, New York, 13901, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
Southgate Medical Group
West Seneca, New York, 14224, United States
Great Lakes Medical Research
Westfield, New York, 14787, United States
PharmQuest
Greensboro, North Carolina, 27401, United States
Crescent Medical Research
Salisbury, North Carolina, 28144, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103, United States
PHA-Adult Medicine
Philadelphia, Pennsylvania, 19146, United States
Radiant Research
Greer, South Carolina, 29651, United States
Tricities Medical Research
Bristol, Tennessee, 37620, United States
Holston Medical Group Clinical Research
Kingsport, Tennessee, 37660, United States
Dallas Diabetes and Endocrine Center
Dallas, Texas, 75230, United States
Diabetes and Glandular Disease Research
San Antonio, Texas, 78229, United States
Walla Walla Clinic
Walla Walla, Washington, 99362, United States
Related Publications (2)
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.
PMID: 22169113DERIVEDBays 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.
PMID: 21752880DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Brian Roberts, M.D.
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2008
First Posted
June 19, 2008
Study Start
August 1, 2007
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
June 12, 2015
Record last verified: 2015-05