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| ID | Type | Description | Link |
|---|---|---|---|
| M8025-20711 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo/Placebo | Placebo Comparator |
| |
| MBX-8025 50 mg/Placebo | Experimental |
| |
| MBX-8025 100 mg/Placebo | Experimental |
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| Placebo/Atorvastatin 20 mg | Active Comparator |
| |
| MBX-8025 50 mg/Atorvastatin 20 mg | Experimental |
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| MBX-8025 100 mg/Atorvastatin 20 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 2 capsules, once a day for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lipid levels will be measured in patients with hyperlipidemia to assess the benefits of the investigational drug | 8 week treatment period |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Brian Roberts, M.D. | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research | Birmingham | Alabama | 35209 | United States | ||
| Anasazi Internal Medicine Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22169113 | Derived | 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. | |
| 21752880 | Derived | 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. |
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| MBX-8025 | Drug | 2 capsules, once daily for 8 weeks |
|
| MBX-8025 | Drug | 2 capsule, once daily for 8 weeks |
|
| Atorvastatin | Drug | 2 capsules, once daily for 8 weeks |
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| MBX-8025 | Drug | 2 capsules, once daily for 8 weeks |
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| MBX-8025 | Drug | 2 capsules, once daily for 8 weeks |
|
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Diabetes/Lipid Management and Research Center | Huntington Beach | California | 92648 | United States |
| Radiant Research | Santa Rosa | California | 95405 | United States |
| Clinical Research Consulting LLC | Milford | Connecticut | 06460 | United States |
| Genesis Research International | Indianapolis | Indiana | 46260 | United States |
| Midwest Institute for Clinical Research Inc. | Indianapolis | Indiana | 46260 | United States |
| L-Marc Research Center | Louisville | Kentucky | 40213 | United States |
| Maine Research Associates | Auburn | Maine | 46260 | United States |
| Health Trends Research LLC | Baltimore | Maryland | 21209 | United States |
| Troy Internal Medicine Research | Troy | Michigan | 48098 | United States |
| Bridgewater Medical Group | Bridgewater | New Jersey | 08807 | United States |
| Clifton-Wallington Medical Group | Clifton | New Jersey | 07013 | United States |
| Rochester Clinical Research | Albuquerque | New Mexico | 87108 | United States |
| United Medical Associates P.C. | Binghamton | New York | 13901 | United States |
| Rochester Clinical Research | Rochester | New York | 14609 | United States |
| Southgate Medical Group | West Seneca | New York | 14224 | United States |
| Great Lakes Medical Research | Westfield | New York | 14787 | United States |
| PharmQuest | Greensboro | North Carolina | 27401 | United States |
| Crescent Medical Research | Salisbury | North Carolina | 28144 | United States |
| Piedmont Medical Research Associates | Winston-Salem | North Carolina | 27103 | United States |
| PHA-Adult Medicine | Philadelphia | Pennsylvania | 19146 | United States |
| Radiant Research | Greer | South Carolina | 29651 | United States |
| Tricities Medical Research | Bristol | Tennessee | 37620 | United States |
| Holston Medical Group Clinical Research | Kingsport | Tennessee | 37660 | United States |
| Dallas Diabetes and Endocrine Center | Dallas | Texas | 75230 | United States |
| Diabetes and Glandular Disease Research | San Antonio | Texas | 78229 | United States |
| Walla Walla Clinic | Walla Walla | Washington | 99362 | United States |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C572244 | (2-methyl-4-(5-methyl-2-(4-trifluoromethyl-phenyl)-2H-(1,2,3)triazol-4-ylmethylsulfanyl)phenoxy)acetic acid |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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