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

Primary Purpose

Obesity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CP-866,087
CP-866,087
CP-866,087
placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, weight loss

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Exploratory biomarkers measured at Day 1, 14, 28, 56, and 84.
Waist circumference measured at Day 1, 7, 14, 28, 42, 56, 70, 84, 94.
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.
Serum Lipids measured at Day 1, 7, 14, 28, 56, 84 and 94.
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.

Full Information

First Posted
May 24, 2007
Last Updated
September 29, 2009
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00479492
Brief Title
Study To Determine The Effects And Safety Of A Weight Loss Compound On Overweight, Otherwise Healthy, Volunteers
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, weight loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CP-866,087
Intervention Description
1 mg of CP-866,087, administered QD for 84 days
Intervention Type
Drug
Intervention Name(s)
CP-866,087
Intervention Description
5 mg of CP-866,087, administered QD for 84 days
Intervention Type
Drug
Intervention Name(s)
CP-866,087
Intervention Description
10 mg of CP-866,087, administered QD for 84 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo administered QD for 84 days
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Exploratory biomarkers measured at Day 1, 14, 28, 56, and 84.
Time Frame
84 days
Title
Waist circumference measured at Day 1, 7, 14, 28, 42, 56, 70, 84, 94.
Time Frame
94 days
Title
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
Title
Serum Lipids measured at Day 1, 7, 14, 28, 56, 84 and 94.
Time Frame
94 days
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Pfizer Investigational Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5051019&StudyName=Study%20To%20Determine%20The%20Effects%20And%20Safety%20Of%20A%20Weight%20Loss%20Compound%20On%20Overweight%2C%20Otherwise%20Healthy%2C%20Volunteers
Description
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Study To Determine The Effects And Safety Of A Weight Loss Compound On Overweight, Otherwise Healthy, Volunteers

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