ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00479492
Recruitment Status : Completed
First Posted : May 28, 2007
Last Update Posted : October 1, 2009
Sponsor:
Information provided by:
Pfizer

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

Condition or disease Intervention/treatment Phase
Obesity Drug: CP-866,087 Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : June 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Drug: CP-866,087
1 mg of CP-866,087, administered QD for 84 days

Experimental: 2 Drug: CP-866,087
5 mg of CP-866,087, administered QD for 84 days

Experimental: 3 Drug: CP-866,087
10 mg of CP-866,087, administered QD for 84 days

Placebo Comparator: 4 Drug: placebo
placebo administered QD for 84 days




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. Exploratory biomarkers measured at Day 1, 14, 28, 56, and 84. [ Time Frame: 84 days ]
  3. Waist circumference measured at Day 1, 7, 14, 28, 42, 56, 70, 84, 94. [ Time Frame: 94 days ]
  4. 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 ]
  5. Serum Lipids measured at Day 1, 7, 14, 28, 56, 84 and 94. [ Time Frame: 94 days ]
  6. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00479492


Locations
United States, Florida
Pfizer Investigational Site
Orlando, Florida, United States, 32809
United States, Michigan
Pfizer Investigational Site
Kalamazoo, Michigan, United States, 49007
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97239
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00479492     History of Changes
Other Study ID Numbers: A5051019
First Posted: May 28, 2007    Key Record Dates
Last Update Posted: October 1, 2009
Last Verified: October 2008

Keywords provided by Pfizer:
Obesity, weight loss

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms