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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00479492

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 II

MedlinePlus related topics: Obesity Weight Control

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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

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
1: Experimental	Drug: CP-866,087 1 mg of CP-866,087, administered QD for 84 days
2: Experimental	Drug: CP-866,087 5 mg of CP-866,087, administered QD for 84 days
3: Experimental	Drug: CP-866,087 10 mg of CP-866,087, administered QD for 84 days
4: Placebo Comparator	Drug: placebo placebo administered QD for 84 days

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

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:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5051019
Study First Received:	May 24, 2007
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00479492 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Obesity, weight loss

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss
Body Weight Changes

Nutrition Disorders
Overnutrition
Overweight
Healthy

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Body Weight Changes
Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on May 07, 2009