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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Hyperlipidemia | Drug: Placebo Drug: MBX-8025 Drug: Atorvastatin | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 183 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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" |
| Study Start Date : | August 2007 |
| Actual Primary Completion Date : | August 2008 |
| Actual Study Completion Date : | August 2008 |
| 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 |
| Experimental: MBX-8025 100 mg/Placebo |
Drug: Placebo
2 capsules, once a day 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: Atorvastatin
2 capsules, once daily for 8 weeks Drug: MBX-8025 2 capsules, once daily for 8 weeks |
| Experimental: MBX-8025 100 mg/Atorvastatin 20 mg |
Drug: Atorvastatin
2 capsules, once daily for 8 weeks Drug: MBX-8025 2 capsules, once daily for 8 weeks |
- Lipid levels will be measured in patients with hyperlipidemia to assess the benefits of the investigational drug [ Time Frame: 8 week treatment period ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00701883
Show 28 study locations
| Study Director: | Brian Roberts, M.D. | CymaBay Therapeutics, Inc. |
| Responsible Party: | CymaBay Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00701883 |
| Other Study ID Numbers: |
70,961 M8025-20711 |
| First Posted: | June 19, 2008 Key Record Dates |
| Last Update Posted: | June 12, 2015 |
| Last Verified: | May 2015 |
|
Cholesterol Hyperlipidemia HDL |
LDL Triglycerides Dyslipidemia |
|
Hyperlipidemias Hyperlipoproteinemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |