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

Pfizer

Status and phase: Completed; Phase 3; Phase 2

Conditions: Obesity

Treatments: Drug: CP-945,598; Drug: sibutramine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00134199

A5351013

Details and patient eligibility

About

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

Enrollment: 282 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind