Obesity
Conditions
Keywords
Obesity, weight loss
Brief summary
The purpose of this study is to determine whether CP-866,087 is effective in the weight loss of overweight patients.
Interventions
DRUGCP-866,087
1 mg of CP-866,087, administered QD for 84 days
DRUGplacebo
placebo administered QD for 84 days
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Body Mass Index (BMI) 30 to 40 kg/m2 and total body weight of \>110 lbs. * Otherwise healthy
Exclusion criteria
* Women must be of non-childbearing potential. * Significant current or history of medical illness.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory biomarkers measured at Day 1, 14, 28, 56, and 84. | 84 days |
| Waist circumference measured at Day 1, 7, 14, 28, 42, 56, 70, 84, 94. | 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 | 29 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 |
| 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 |
Countries
United States
Outcome results
None listed