Clinical trial NCT00701883: Safety and Benefit of MBX-8025 With and Without Commonly Used Statins in Moderately Overweight Patients With High Cholesterol
Official title: 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"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperlipidemia
Keywords: Cholesterol
Hyperlipidemia
HDL
LDL
Triglycerides
Dyslipidemia
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2008-06-19
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lipid levels will be measured in patients with hyperlipidemia to assess the benefits of the investigational drug
timeFrame: 8 week treatment period
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Radiant Research
state: Alabama
city: Phoenix
country: United States
facility: Anasazi Internal Medicine Research
state: Arizona
city: Huntington Beach
country: United States
facility: Diabetes/Lipid Management and Research Center
state: California
city: Santa Rosa
country: United States
facility: Radiant Research
state: California
city: Milford
country: United States
facility: Clinical Research Consulting LLC
state: Connecticut
city: Indianapolis
country: United States
facility: Genesis Research International
state: Indiana
city: Indianapolis
country: United States
facility: Midwest Institute for Clinical Research Inc.
state: Indiana
city: Louisville
country: United States
facility: L-Marc Research Center
state: Kentucky
city: Auburn
country: United States
facility: Maine Research Associates
state: Maine
city: Baltimore
country: United States
facility: Health Trends Research LLC
state: Maryland
city: Troy
country: United States
facility: Troy Internal Medicine Research
state: Michigan
city: Bridgewater
country: United States
facility: Bridgewater Medical Group
state: New Jersey
city: Clifton
country: United States
facility: Clifton-Wallington Medical Group
state: New Jersey
city: Albuquerque
country: United States
facility: Rochester Clinical Research
state: New Mexico
city: Binghamton
country: United States
facility: United Medical Associates P.C.
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: West Seneca
country: United States
facility: Southgate Medical Group
state: New York
city: Westfield
country: United States
facility: Great Lakes Medical Research
state: New York
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Salisbury
country: United States
facility: Crescent Medical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research Associates
state: North Carolina
city: Philadelphia
country: United States
facility: PHA-Adult Medicine
state: Pennsylvania
city: Greer
country: United States
facility: Radiant Research
state: South Carolina
city: Bristol
country: United States
facility: Tricities Medical Research
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group Clinical Research
state: Tennessee
city: Dallas
country: United States
facility: Dallas Diabetes and Endocrine Center
state: Texas
city: San Antonio
country: United States
facility: Diabetes and Glandular Disease Research
state: Texas
city: Walla Walla
country: United States
facility: Walla Walla Clinic
state: Washington
Study officials:
affiliation: Gilead Sciences
name: Brian Roberts, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.