The purpose of this study is to determine whether CP-866,087 is effective in the weight loss of overweight patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
94
1 mg of CP-866,087, administered QD for 84 days
5 mg of CP-866,087, administered QD for 84 days
10 mg of CP-866,087, administered QD for 84 days
Pfizer Investigational Site
Orlando, Florida, United States
Pfizer Investigational Site
Kalamazoo, Michigan, United States
Pfizer Investigational Site
Portland, Oregon, United States
Pfizer Investigational Site
San Antonio, Texas, United States
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.
Time frame: 94 days
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
Time frame: 29 days
Exploratory biomarkers measured at Day 1, 14, 28, 56, and 84.
Time frame: 84 days
Waist circumference measured at Day 1, 7, 14, 28, 42, 56, 70, 84, 94.
Time frame: 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.
Time frame: 94 days
Serum Lipids measured at Day 1, 7, 14, 28, 56, 84 and 94.
Time frame: 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.
Time frame: 94 days
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placebo administered QD for 84 days