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

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
MBX-8025
MBX-8025
Atorvastatin
MBX-8025
MBX-8025
Sponsored by
CymaBay Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia focused on measuring Cholesterol, Hyperlipidemia, HDL, LDL, Triglycerides, Dyslipidemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radiant Research
  • Anasazi Internal Medicine Research
  • Diabetes/Lipid Management and Research Center
  • Radiant Research
  • Clinical Research Consulting LLC
  • Genesis Research International
  • Midwest Institute for Clinical Research Inc.
  • L-Marc Research Center
  • Maine Research Associates
  • Health Trends Research LLC
  • Troy Internal Medicine Research
  • Bridgewater Medical Group
  • Clifton-Wallington Medical Group
  • Rochester Clinical Research
  • United Medical Associates P.C.
  • Rochester Clinical Research
  • Southgate Medical Group
  • Great Lakes Medical Research
  • PharmQuest
  • Crescent Medical Research
  • Piedmont Medical Research Associates
  • PHA-Adult Medicine
  • Radiant Research
  • Tricities Medical Research
  • Holston Medical Group Clinical Research
  • Dallas Diabetes and Endocrine Center
  • Diabetes and Glandular Disease Research
  • Walla Walla Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Active Comparator

Experimental

Experimental

Arm Label

Placebo/Placebo

MBX-8025 50 mg/Placebo

MBX-8025 100 mg/Placebo

Placebo/Atorvastatin 20 mg

MBX-8025 50 mg/Atorvastatin 20 mg

MBX-8025 100 mg/Atorvastatin 20 mg

Arm Description

Outcomes

Primary Outcome Measures

Lipid levels will be measured in patients with hyperlipidemia to assess the benefits of the investigational drug

Secondary Outcome Measures

Full Information

First Posted
June 17, 2008
Last Updated
May 19, 2015
Sponsor
CymaBay Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00701883
Brief Title
Safety and Benefit of MBX-8025 With and Without Commonly Used Statins in Moderately Overweight Patients With High Cholesterol
Acronym
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"
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CymaBay Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
Keywords
Cholesterol, Hyperlipidemia, HDL, LDL, Triglycerides, Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo/Placebo
Arm Type
Placebo Comparator
Arm Title
MBX-8025 50 mg/Placebo
Arm Type
Experimental
Arm Title
MBX-8025 100 mg/Placebo
Arm Type
Experimental
Arm Title
Placebo/Atorvastatin 20 mg
Arm Type
Active Comparator
Arm Title
MBX-8025 50 mg/Atorvastatin 20 mg
Arm Type
Experimental
Arm Title
MBX-8025 100 mg/Atorvastatin 20 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 capsules, once a day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
MBX-8025
Intervention Description
2 capsules, once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
MBX-8025
Intervention Description
2 capsule, once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
2 capsules, once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
MBX-8025
Intervention Description
2 capsules, once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
MBX-8025
Intervention Description
2 capsules, once daily for 8 weeks
Primary Outcome Measure Information:
Title
Lipid levels will be measured in patients with hyperlipidemia to assess the benefits of the investigational drug
Time Frame
8 week treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Roberts, M.D.
Organizational Affiliation
CymaBay Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Radiant Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Anasazi Internal Medicine Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Diabetes/Lipid Management and Research Center
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Radiant Research
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
Clinical Research Consulting LLC
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
Genesis Research International
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Midwest Institute for Clinical Research Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
L-Marc Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Maine Research Associates
City
Auburn
State/Province
Maine
ZIP/Postal Code
46260
Country
United States
Facility Name
Health Trends Research LLC
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
Facility Name
Troy Internal Medicine Research
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Bridgewater Medical Group
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Clifton-Wallington Medical Group
City
Clifton
State/Province
New Jersey
ZIP/Postal Code
07013
Country
United States
Facility Name
Rochester Clinical Research
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
United Medical Associates P.C.
City
Binghamton
State/Province
New York
ZIP/Postal Code
13901
Country
United States
Facility Name
Rochester Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Southgate Medical Group
City
West Seneca
State/Province
New York
ZIP/Postal Code
14224
Country
United States
Facility Name
Great Lakes Medical Research
City
Westfield
State/Province
New York
ZIP/Postal Code
14787
Country
United States
Facility Name
PharmQuest
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Crescent Medical Research
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Piedmont Medical Research Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
PHA-Adult Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Name
Radiant Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Tricities Medical Research
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Holston Medical Group Clinical Research
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Dallas Diabetes and Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Diabetes and Glandular Disease Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Walla Walla Clinic
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22169113
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.
Results Reference
derived
PubMed Identifier
21752880
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.
Results Reference
derived

Learn more about this trial

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

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