Safety, Toleration and Efficacy of CP-741,952 for the Treatment of Obesity

Obesity Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00367783
• Other study ID #: A7081004
• Status: Terminated
• Phase: Phase 2
• First received: May 30, 2006
• Last updated: July 29, 2011
• Start date: June 2006
• Est. completion date: April 2007

Study information

• Verified date: July 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI of 30-40 kg/m2

Exclusion Criteria:

• Women of childbearing potential

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• CP-741,952

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Ann Arbor	Michigan
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Kalamazoo	Michigan
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Loss, toleration, safety
Secondary	Waist Circumference, serum lipids

External Links

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