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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00479492
First received: May 24, 2007
Last updated: September 29, 2009
Last verified: October 2008
  Purpose

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


Condition Intervention Phase
Obesity
Drug: CP-866,087
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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. [ Time Frame: 94 days ] [ Designated as safety issue: No ]

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 [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
  • Exploratory biomarkers measured at Day 1, 14, 28, 56, and 84. [ Time Frame: 84 days ] [ Designated as safety issue: No ]
  • Waist circumference measured at Day 1, 7, 14, 28, 42, 56, 70, 84, 94. [ Time Frame: 94 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Serum Lipids measured at Day 1, 7, 14, 28, 56, 84 and 94. [ Time Frame: 94 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 94
Study Start Date: June 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00479492     History of Changes
Other Study ID Numbers: A5051019
Study First Received: May 24, 2007
Last Updated: September 29, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Obesity, weight loss

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on August 20, 2014