Study To Determine The Effects And Safety Of A Weight Loss Compound On Overweight, Otherwise Healthy, Volunteers
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
1 other identifier
interventional
94
1 country
4
Brief Summary
The purpose of this study is to determine whether CP-866,087 is effective in the weight loss of overweight patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 obesity
Started Jun 2007
Shorter than P25 for phase_2 obesity
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2007
CompletedFirst Posted
Study publicly available on registry
May 28, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedOctober 1, 2009
October 1, 2008
7 months
May 24, 2007
September 29, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
94 days
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (4)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Body Mass Index (BMI) 30 to 40 kg/m2 and total body weight of \>110 lbs.
- Otherwise healthy
You may not qualify if:
- Women must be of non-childbearing potential.
- Significant current or history of medical illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (4)
Pfizer Investigational Site
Orlando, Florida, 32809, United States
Pfizer Investigational Site
Kalamazoo, Michigan, 49007, United States
Pfizer Investigational Site
Portland, Oregon, 97239, United States
Pfizer Investigational Site
San Antonio, Texas, 78209, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 24, 2007
First Posted
May 28, 2007
Study Start
June 1, 2007
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
October 1, 2009
Record last verified: 2008-10