Official Title: “A 6-Month, Randomized, Double-Blind, Placebo And Positive-Controlled Phase 2b Study To Evaluate The Effect Of Various Doses Of CP-945,598 On Weight Loss In Obese Subjects”

To evaluate the effect of 6-month administration of CP-945,598 on: - weight loss and waist circumference, - blood pressure, cholesterol, glucose - other biochemical variables like insulin, leptin, ghrelin, adiponectin, PAI 1, TNF-α and hsCRP - the relationship between the concentration of the drug on the blood and the above parameters - physical and psychosocial functioning, weight related symptoms, treatment satisfaction, appetite/hunger/satiety/craving and mood, anxiety, anhedonia and depression

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: CP-945,598
• Drug: sibutramine

Primary Measures

• Determine the effect of various doses of CP 945,598 on body weight in obese subjects after 24 weeks of dosing

Secondary Measures

• Evaluate the safety and tolerability of CP 945,598 in a 26 week outpatient setting;; -Explore the effect of CP 945,598 on: waist circumference, PD measurements of selected biochemical variables related to energy deficit and weight loss includ

Inclusion Criteria:

• Male and/or female subjects without clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12 lead ECG and clinical laboratory tests
• Body Mass Index (BMI) ³30 and <40 kg/m2, for subjects with no additional
• co morbidities; BMI ³27 kg/m2 and <40 kg/m2, for subjects with co morbidities
• [history of essential hypertension and/or dyslipidemia defined as high LDL (³160 mg/dL) or high total cholesterol (³240 mg/dL)];

Exclusion Criteria:

• Subjects with resting sitting systolic blood pressure of 140 mmHg or greater or diastolic blood pressure of 90 mmHg or greater.
• Subjects with type 2 diabetes or fasting blood glucose concentration ³126 mg/dL;
• Subjects with a history of eating disorders like anorexia nervosa or bulimia nervosa
• Subjects on prescription and non-prescription appetite or weight modifying drugs

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00134199

Study ID Number: A5351013

ClinicalTrials.gov Identifier: NCT00134199

Health Authority: United States: Food and Drug Administration