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The purpose of this study is to determine whether CP-866,087 is effective in the weight loss of overweight patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-866,087 | Drug | 1 mg of CP-866,087, administered QD for 84 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Measure the effect of weight loss over 12 weeks in overweight otherwise healthy patients. Measurements will include body weight and waist circumference. Measurements will occur at Day 1, 7, 14, 28, 42, 56, 70, 84 and 94. | 94 days |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the effect of 4 weeks of dosing of 3 different doses of CP-866,087 on 24-hour urinary cortisol levels. Measured at Day 1 and Day 29 | 29 days | |
| Exploratory biomarkers measured at Day 1, 14, 28, 56, and 84. | 84 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Orlando | Florida | 32809 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000626492 | CP-866,087 |
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| CP-866,087 |
| Drug |
5 mg of CP-866,087, administered QD for 84 days |
|
| CP-866,087 | Drug | 10 mg of CP-866,087, administered QD for 84 days |
|
| placebo | Drug | placebo administered QD for 84 days |
|
| Waist circumference measured at Day 1, 7, 14, 28, 42, 56, 70, 84, 94. | 94 days |
| To explore changes in pharmacodynamics (PD) markers of efficacy resulting from multiple PO doses of CP-866,087, including waist circumference, and serum lipids and exploratory biomarkers. | 94 days |
| Serum Lipids measured at Day 1, 7, 14, 28, 56, 84 and 94. | 94 days |
| To explore the effects of chronic, 12-week dosing with CP-866,087 on neuroendocrine endpoints, including testosterone, TSH, T4, and IGF1. Measured at Day 1, 28, 84 and 94. | 94 days |
| Kalamazoo |
| Michigan |
| 49007 |
| United States |
| Pfizer Investigational Site | Portland | Oregon | 97239 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78209 | United States |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |