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

Hyperlipidemia Clinical Trial

— MBX-8025  

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00701883
• Other study ID #: 70,961
• Secondary ID: M8025-20711
• Status: Completed
• Phase: Phase 2
• First received: June 17, 2008
• Last updated: May 19, 2015
• Start date: August 2007
• Est. completion date: August 2008

Study information

• Verified date: May 2015
• Source: CymaBay Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Rochester Clinical Research	Albuquerque	New Mexico
United States	Maine Research Associates	Auburn	Maine
United States	Health Trends Research LLC	Baltimore	Maryland
United States	United Medical Associates P.C.	Binghamton	New York
United States	Radiant Research	Birmingham	Alabama
United States	Bridgewater Medical Group	Bridgewater	New Jersey
United States	Tricities Medical Research	Bristol	Tennessee
United States	Clifton-Wallington Medical Group	Clifton	New Jersey
United States	Dallas Diabetes and Endocrine Center	Dallas	Texas
United States	PharmQuest	Greensboro	North Carolina
United States	Radiant Research	Greer	South Carolina
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	Holston Medical Group Clinical Research	Kingsport	Tennessee
United States	L-Marc Research Center	Louisville	Kentucky
United States	Clinical Research Consulting LLC	Milford	Connecticut
United States	PHA-Adult Medicine	Philadelphia	Pennsylvania
United States	Anasazi Internal Medicine Research	Phoenix	Arizona
United States	Rochester Clinical Research	Rochester	New York
United States	Crescent Medical Research	Salisbury	North Carolina
United States	Diabetes and Glandular Disease Research	San Antonio	Texas
United States	Radiant Research	Santa Rosa	California
United States	Troy Internal Medicine Research	Troy	Michigan
United States	Walla Walla Clinic	Walla Walla	Washington
United States	Southgate Medical Group	West Seneca	New York
United States	Great Lakes Medical Research	Westfield	New York
United States	Piedmont Medical Research Associates	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
CymaBay Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipid levels will be measured in patients with hyperlipidemia to assess the benefits of the investigational drug		8 week treatment period	No