Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00701883
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : June 12, 2015
Sponsor:
Information provided by (Responsible Party):
CymaBay Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE June 17, 2008
First Posted Date  ICMJE June 19, 2008
Last Update Posted Date June 12, 2015
Study Start Date  ICMJE August 2007
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2008)
Lipid levels will be measured in patients with hyperlipidemia to assess the benefits of the investigational drug [ Time Frame: 8 week treatment period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Benefit of MBX-8025 With and Without Commonly Used Statins in Moderately Overweight Patients With High Cholesterol
Official Title  ICMJE 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"
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hyperlipidemia
Intervention  ICMJE
  • Drug: Placebo
    2 capsules, once a day for 8 weeks
  • Drug: MBX-8025
    2 capsules, once daily for 8 weeks
  • Drug: MBX-8025
    2 capsule, once daily for 8 weeks
  • Drug: Atorvastatin
    2 capsules, once daily for 8 weeks
Study Arms  ICMJE
  • Placebo Comparator: Placebo/Placebo
    Intervention: Drug: Placebo
  • Experimental: MBX-8025 50 mg/Placebo
    Interventions:
    • Drug: Placebo
    • Drug: MBX-8025
  • Experimental: MBX-8025 100 mg/Placebo
    Interventions:
    • Drug: Placebo
    • Drug: MBX-8025
  • Active Comparator: Placebo/Atorvastatin 20 mg
    Interventions:
    • Drug: Placebo
    • Drug: Atorvastatin
  • Experimental: MBX-8025 50 mg/Atorvastatin 20 mg
    Interventions:
    • Drug: Atorvastatin
    • Drug: MBX-8025
  • Experimental: MBX-8025 100 mg/Atorvastatin 20 mg
    Interventions:
    • Drug: Atorvastatin
    • Drug: MBX-8025
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2015)
183
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2008)
180
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00701883
Other Study ID Numbers  ICMJE 70,961
M8025-20711
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CymaBay Therapeutics, Inc.
Study Sponsor  ICMJE CymaBay Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Brian Roberts, M.D. CymaBay Therapeutics, Inc.
PRS Account CymaBay Therapeutics, Inc.
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP