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

Phase 2

Completed

• Conditions: Obesity
• Interventions: Drug: CP-866,087; Drug: placebo

• Registration Number: NCT00479492
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to determine whether CP-866,087 is effective in the weight loss of overweight patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-05-24
• Study First Submitted QC: 2007-05-24
• Study First Posted: 2007-05-28
• Study Start: 2007-06
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2008-10
• Disposition First Submitted: 2009-09-29
• Disposition First Submitted QC: 2009-09-29
• Last Update Submitted: 2009-09-29
• Disposition First Posted: 2009-10-01
• Last Update Posted: 2009-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	CP-866,087	-
3	CP-866,087	-
4	placebo	-
1	CP-866,087	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 San Antonio, Texas, United States