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

This study has been completed.
Sponsor:
Information provided by:
CymaBay Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00701883
First received: June 17, 2008
Last updated: August 21, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Hyperlipidemia
Drug: MBX8025
Drug: placebo (unspecified)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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"

Resource links provided by NLM:


Further study details as provided by CymaBay Therapeutics, Inc.:

Primary Outcome Measures:
  • Lipid levels will be measured in patients with hyperlipidemia to assess the benefits of the investigational drug [ Time Frame: 8 week treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: August 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: placebo (unspecified)
placebo
Experimental: 2 Drug: MBX8025
Capsule, once a day for 8 weeks
Other Name: Lipitor - active comparator
Experimental: 3 Drug: MBX8025
Capsule, once a day for 8 weeks
Other Name: Lipitor - active comparator
Active Comparator: 4 Drug: MBX8025
Capsule, once a day for 8 weeks
Other Name: Lipitor - active comparator
Experimental: 5 Drug: MBX8025
Capsule, once a day for 8 weeks
Other Name: Lipitor - active comparator
Experimental: 6 Drug: MBX8025
Capsule, once a day for 8 weeks
Other Name: Lipitor - active comparator

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701883

  Show 28 Study Locations
Sponsors and Collaborators
CymaBay Therapeutics, Inc.
Investigators
Study Director: Brian Roberts, M.D. CymaBay Therapeutics, Inc.
  More Information

No publications provided by CymaBay Therapeutics, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Metabolex, Inc., Metabolex
ClinicalTrials.gov Identifier: NCT00701883     History of Changes
Other Study ID Numbers: 70,961, M8025-20711
Study First Received: June 17, 2008
Last Updated: August 21, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by CymaBay Therapeutics, Inc.:
Cholesterol
Hyperlipidemia
HDL
LDL
Triglycerides
Dyslipidemia

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 22, 2014