Study To Determine The Effects And Safety Of A Weight Loss Compound On Overweight, Otherwise Healthy, Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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A 12-Week, Randomized, Subject And Investigator Blind, Placebo-Controlled Trial To Evaluate The Effect Of CP-866,087 On Weight Loss In Obese, Otherwise Healthy Adult Subjects

Conditions
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Obesity

Intervention / Treatment
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* Drug: CP-866,087
* Drug: CP-866,087
* Drug: CP-866,087
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: CP-866,087<br>* 1 mg of CP-866,087, administered QD for 84 days<br>|
| Experimental: 2<br> | Drug: CP-866,087<br>* 5 mg of CP-866,087, administered QD for 84 days<br>|
| Experimental: 3<br> | Drug: CP-866,087<br>* 10 mg of CP-866,087, administered QD for 84 days<br>|
| Placebo Comparator: 4<br> | Drug: placebo<br>* placebo administered QD for 84 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, weight loss