Study To Determine The Effects And Safety Of A Weight Loss Compound On Overweight, Otherwise Healthy, Volunteers
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00479492
First received: May 24, 2007
Last updated: September 29, 2009
Last verified: October 2008
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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
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 May 16, 2013