A 14-Month Study On The Effects Of CP-945,598 For The Prevention Of Weight Regain In Obese Patients

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00483171
First received: June 4, 2007
Last updated: November 5, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to determine if CP-945,598 is effective in the prevention of weight regain in obese subjects.


Condition Intervention Phase
Obesity
Drug: CP-945,598
Behavioral: Non-pharmacological weight loss program (NPP)
Behavioral: Low Calorie Diet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 14-Month, Randomized, Double-Blind,Placebo-Controlled Phase 3 Study To Evaluate The Long-Term Efficacy And Safety of CP-945,598 In Prevention Of Weight Regain In Obese Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percent weight regained during the 12 month treatment period after a prior weight loss on the low calorie diet (8 weeks). [ Time Frame: 14 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To explore the effect of CP 954, 598 on: Waist circumference [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability of CP 945,598 urine and blood tests [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • To explore the effect of CP 954, 598 on: Pharmacodynamic measurements including fasting insulin, fasting plasma glucose, adiponectin [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • To explore the effect of CP 954, 598 on: Patient reported outcomes: Power of Food Scale and Three factor Eating Scale [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • To explore the effect of CP 954, 598 GAD 7 and PHQ 9 self report questionnaires. and C-SSRS semi structured interview [ Time Frame: 14 months ] [ Designated as safety issue: No ]

Enrollment: 699
Study Start Date: January 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: CP-945,598
CP-945,598
Non-pharmacological weight loss program (NPP) Behavioral: Non-pharmacological weight loss program (NPP)
Nutrition counseling, exercise monitoring and behavioral management will occur for all arms during the NPP.
Low Calorie Diet Behavioral: Low Calorie Diet
Low calorie diet

Detailed Description:

The CP-945,598 program was terminated on November 3, 2008 due to changing regulatory perspectives on the risk/benefit profile of the CB1 class and likely new regulatory requirements for approval. No safety issues were involved in the termination decision.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be overweight (BMI) >/=30 kg/m2, for subjects without co morbidities; >/=27 kg/m2 for subjects with co morbidities
  • Subjects who are willing and able to comply with 8 week Low Calorie Diet, scheduled visits, treatment plan, laboratory tests, and other trial procedures.

Exclusion Criteria:

  • Participation in a formal weight loss program or significant weight loss (fluctuation >5% of total body weight) in the past 3 months.
  • Subjects with serious medical or psychiatric conditions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483171

  Show 26 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00483171     History of Changes
Other Study ID Numbers: A5351028
Study First Received: June 4, 2007
Last Updated: November 5, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014