Clinical trial NCT00134199: A Study Of 6-Month Duration To Evaluate The Weight Loss Effect Of Various Doses Of CP-945,598 In Obese Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Obesity
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-24
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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-Î± 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


Eligibility 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) Â³30 and \<40 kg/m2, for subjects with no additional
* co morbidities; BMI Â³27 kg/m2 and \<40 kg/m2, for subjects with co morbidities \[history of essential hypertension and/or dyslipidemia defined as high LDL (Â³160 mg/dL) or high total cholesterol (Â³240 mg/dL)\];

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 Â³126 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

Primary outcomes:
measure: Determine the effect of various doses of CP 945,598 on body weight in obese subjects after 24 weeks of dosing
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Kissimmee
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Milford
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: