Safety, Toleration and Efficacy of CP-741,952 for the Treatment of Obesity
Primary Purpose
Obesity
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CP-741,952
Sponsored by

About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria: BMI of 30-40 kg/m2 Exclusion Criteria: Women of childbearing potential
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
Weight Loss, toleration, safety
Secondary Outcome Measures
Waist Circumference, serum lipids
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00367783
Brief Title
Safety, Toleration and Efficacy of CP-741,952 for the Treatment of Obesity
Official Title
A 12-Week, Phase 2A, Randomized, Subject And Investigator Blind, Placebo-Controlled Trial To Evaluate The Effect Of CP-741,952 On Weight Loss In Otherwise Healthy Overweight And Obese Adult Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Terminated
Why Stopped
See Detailed Description for termination reason.
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (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-741,952 is effective in the treatment of obesity and to determine 12 week safety and toleration.
Detailed Description
Following review of the preliminary data from completed study A7081004, the development program for CP-741,952 was terminated on 15 March 2007. Primary reasons for program termination included a lack of significant efficacy at all doses investigated and an increased incidence of mild to moderate elevations in serum transaminases, primarily alanine aminotransferase (ALT), and liver fat content, in treated compared to placebo subjects. A synopsis will be created and will include greater detail on these findings.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
CP-741,952
Primary Outcome Measure Information:
Title
Weight Loss, toleration, safety
Secondary Outcome Measure Information:
Title
Waist Circumference, serum lipids
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI of 30-40 kg/m2
Exclusion Criteria:
Women of childbearing potential
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
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
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
New York
State/Province
New York
ZIP/Postal Code
10021-7903
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7081004&StudyName=Safety%2C%20Toleration%20and%20Efficacy%20of%20CP-741%2C952%20for%20the%20Treatment%20of%20Obesity
Description
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Safety, Toleration and Efficacy of CP-741,952 for the Treatment of Obesity
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