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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00134199

Enrollment

282

Registered

2005-08-24

Start date

2005-03-31

Completion date

2005-11-30

Last updated

2009-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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

Interventions

DRUGCP-945,598

DRUGsibutramine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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) 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026