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Trial record 1 of 1 for:    NCT00479492
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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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ClinicalTrials.gov Identifier: NCT00479492
Recruitment Status : Completed
First Posted : May 28, 2007
Last Update Posted : October 1, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE May 24, 2007
First Posted Date  ICMJE May 28, 2007
Last Update Posted Date October 1, 2009
Study Start Date  ICMJE June 2007
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2007)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2007)
Measure the effect of weight loss over 12 weeks in overweight otherwise healthy patients. Measurements will include body weight and waist circumference. [ Time Frame: Measurements will occur at Day 1, 7, 14, 28, 42, 56, 70, 84 and 94. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2008)
  • 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 ]
  • Exploratory biomarkers measured at Day 1, 14, 28, 56, and 84. [ Time Frame: 84 days ]
  • Waist circumference measured at Day 1, 7, 14, 28, 42, 56, 70, 84, 94. [ Time Frame: 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. [ Time Frame: 94 days ]
  • Serum Lipids measured at Day 1, 7, 14, 28, 56, 84 and 94. [ Time Frame: 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. [ Time Frame: 94 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2007)
  • To characterize the effect of 4 weeks of dosing of 3 different doses of CP-866,087 on 24-hour urinary cortisol levels. [ Time Frame: Measured at Day 1 and Day 29 ]
  • 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 [ Time Frame: Measured at Day 1, 7, 14, 28, 56, 84 and 94. ]
  • Exploratory biomarkers [ Time Frame: Measured at Day 1, 14, 28, 56, and 84. ]
  • Waist circumference [ Time Frame: Measured at Day 1, 7, 14, 28, 42, 56, 70, 84, 94. ]
  • To explore the effects of chronic, 12-week dosing with CP-866,087 on neuroendocrine endpoints, including testosterone, TSH, T4, and IGF1. [ Time Frame: Measured at Day 1, 28, 84 and 94. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study To Determine The Effects And Safety Of A Weight Loss Compound On Overweight, Otherwise Healthy, Volunteers
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Drug: CP-866,087
    1 mg of CP-866,087, administered QD for 84 days
  • Drug: CP-866,087
    5 mg of CP-866,087, administered QD for 84 days
  • Drug: CP-866,087
    10 mg of CP-866,087, administered QD for 84 days
  • Drug: placebo
    placebo administered QD for 84 days
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: CP-866,087
  • Experimental: 2
    Intervention: Drug: CP-866,087
  • Experimental: 3
    Intervention: Drug: CP-866,087
  • Placebo Comparator: 4
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2008)
94
Original Enrollment  ICMJE
 (submitted: May 24, 2007)
96
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00479492
Other Study ID Numbers  ICMJE A5051019
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP