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

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Sibutramine

Criteria

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