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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00479492
• Other study ID #: A5051019
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2007
• Last updated: September 29, 2009
• Start date: June 2007
• Est. completion date: January 2008

Study information

• Verified date: October 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Drug:
• CP-866,087
1 mg of CP-866,087, administered QD for 84 days
• CP-866,087
5 mg of CP-866,087, administered QD for 84 days
• CP-866,087
10 mg of CP-866,087, administered QD for 84 days
• placebo
placebo administered QD for 84 days

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Kalamazoo	Michigan
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	Exploratory biomarkers measured at Day 1, 14, 28, 56, and 84.		84 days	No
Secondary	Waist circumference measured at Day 1, 7, 14, 28, 42, 56, 70, 84, 94.		94 days	No
Secondary	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	No
Secondary	Serum Lipids measured at Day 1, 7, 14, 28, 56, 84 and 94.		94 days	No
Secondary	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	Yes

External Links

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