CClinicalTrials.gg
CompletedNCT00134199Updated Aug 12, 2009

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

A Phase 2/3 interventional study of CP-945,598 and sibutramine in Obesity, sponsored by Pfizer. Completed at 15 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-08-12.

Sponsored by Pfizer · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
282
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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
02

Conditions studied

  • Obesity

Browse trials for

03

In context

Weight Loss

1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.

This study's enrollment of 282 is above the median of 73 across 1,496 interventional studies indexed under Weight Loss.

Browse Weight Loss studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
282 participants (actual)

Interventions

  • DrugCP-945,598
  • Drugsibutramine
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. 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

07

Study locations

15 sites
  • Pfizer Investigational Site
    Clearwater, Florida 33761, United States
  • Pfizer Investigational Site
    Kissimmee, Florida 34741, United States
  • Pfizer Investigational Site
    Orlando, Florida 32809, United States
  • Pfizer Investigational Site
    Lexington, Kentucky 40509, United States
  • Pfizer Investigational Site
    Louisville, Kentucky 40213, United States
  • Pfizer Investigational Site
    Baton Rouge, Louisiana 70808, United States
  • Pfizer Investigational Site
    Milford, Massachusetts 01757, United States
  • Pfizer Investigational Site
    New York, New York 10021, United States
  • Pfizer Investigational Site
    Charlotte, North Carolina 28211, United States
  • Pfizer Investigational Site
    Nashville, Tennessee 37203, United States
  • Pfizer Investigational Site
    Dallas, Texas 75231, United States
  • Pfizer Investigational Site
    Dallas, Texas 75247, United States
  • Pfizer Investigational Site
    San Antonio, Texas 78229, United States
  • Pfizer Investigational Site
    Tacoma, Washington 98403, United States
  • Pfizer Investigational Site
    Tacoma, Washington 98418, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00134199
Lead sponsor
Pfizer
First posted
Aug 24, 2005
Start date
Mar 2005
Completion
Nov 2005
Last update
Aug 12, 2009

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2006. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion