Study To Determine The Effects And Safety Of A Weight Loss Compound On Overweight, Otherwise Healthy, Volunteers
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00479492
Collaborator
(none)
94
4
4
7
23.5
3.3
Study Details
Study Description
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 |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
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
:
Jun 1, 2007
Actual Primary Completion Date
:
Jan 1, 2008
Actual Study Completion Date
:
Jan 1, 2008
Arms and Interventions
| 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
|
Outcome Measures
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. [94 days]
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 [29 days]
- Exploratory biomarkers measured at Day 1, 14, 28, 56, and 84. [84 days]
- Waist circumference measured at Day 1, 7, 14, 28, 42, 56, 70, 84, 94. [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. [94 days]
- Serum Lipids measured at Day 1, 7, 14, 28, 56, 84 and 94. [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. [94 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Orlando | Florida | United States | 32809 |
| 2 | Pfizer Investigational Site | Kalamazoo | Michigan | United States | 49007 |
| 3 | Pfizer Investigational Site | Portland | Oregon | United States | 97239 |
| 4 | Pfizer Investigational Site | San Antonio | Texas | United States | 78209 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00479492
Other Study ID Numbers:
- A5051019
First Posted:
May 28, 2007
Last Update Posted:
Oct 1, 2009
Last Verified:
Oct 1, 2008