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

May 19, 2015 updated by: CymaBay Therapeutics, Inc.

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"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

183

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Radiant Research
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Anasazi Internal Medicine Research
    • California
      • Huntington Beach, California, United States, 92648
        • Diabetes/Lipid Management and Research Center
      • Santa Rosa, California, United States, 95405
        • Radiant Research
    • Connecticut
      • Milford, Connecticut, United States, 06460
        • Clinical Research Consulting LLC
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Genesis Research International
      • Indianapolis, Indiana, United States, 46260
        • Midwest Institute for Clinical Research Inc.
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • L-MARC Research Center
    • Maine
      • Auburn, Maine, United States, 46260
        • Maine Research Associates
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • Health Trends Research LLC
    • Michigan
      • Troy, Michigan, United States, 48098
        • Troy Internal Medicine Research
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Bridgewater Medical Group
      • Clifton, New Jersey, United States, 07013
        • Clifton-Wallington Medical Group
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Rochester Clinical Research
    • New York
      • Binghamton, New York, United States, 13901
        • United Medical Associates P.C.
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research
      • West Seneca, New York, United States, 14224
        • Southgate Medical Group
      • Westfield, New York, United States, 14787
        • Great Lakes Medical Research
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • PharmQuest
      • Salisbury, North Carolina, United States, 28144
        • Crescent Medical Research
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Medical Research Associates
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146
        • PHA-Adult Medicine
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Radiant Research
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Tricities Medical Research
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group Clinical Research
    • Texas
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes and Endocrine Center
      • San Antonio, Texas, United States, 78229
        • Diabetes and Glandular Disease Research
    • Washington
      • Walla Walla, Washington, United States, 99362
        • Walla Walla Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo/Placebo
Drug: Placebo
2 capsules, once a day for 8 weeks
Experimental: MBX-8025 50 mg/Placebo
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
Experimental: MBX-8025 100 mg/Placebo
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
Active Comparator: Placebo/Atorvastatin 20 mg
Drug: Placebo
2 capsules, once a day for 8 weeks
Drug: Atorvastatin
2 capsules, once daily for 8 weeks
Experimental: MBX-8025 50 mg/Atorvastatin 20 mg
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
Experimental: MBX-8025 100 mg/Atorvastatin 20 mg
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lipid levels will be measured in patients with hyperlipidemia to assess the benefits of the investigational drug
Time Frame: 8 week treatment period
8 week treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CymaBay Therapeutics, Inc.

Investigators

  • Study Director: Brian Roberts, M.D., CymaBay Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

June 17, 2008

First Submitted That Met QC Criteria

June 18, 2008

First Posted (Estimate)

June 19, 2008

Study Record Updates

Last Update Posted (Estimate)

June 12, 2015

Last Update Submitted That Met QC Criteria

May 19, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 70,961
  • M8025-20711

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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