A Study Of 6-Month Duration To Evaluate The Weight Loss Effect Of Various Doses Of CP-945,598 In Obese Subjects

Phase 2

Completed

• Conditions: Obesity

• Registration Number: NCT00134199
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-08-22
• Study First Submitted QC: 2005-08-22
• Study First Posted: 2005-08-24
• Study Completion: 2005-11
• Status Verified: 2006-04
• Last Update Submitted: 2009-08-11
• Last Update Posted: 2009-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Tacoma, Washington, United States