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

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00483171
• Collaborator: (none)
• Enrollment: 699
• Locations: 26
• Arms: 3
• Duration (Months): 12
• Patients Per Site: 26.9
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

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

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

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 699 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: CP-945,598; CP-945,598
Other: 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.
Other: Low Calorie Diet	Behavioral: Low Calorie Diet; Low calorie diet

Outcome Measures

Primary Outcome Measures

1. Percent weight regained during the 12 month treatment period after a prior weight loss on the low calorie diet (8 weeks). [14 months]

Secondary Outcome Measures

1. To explore the effect of CP 954, 598 on: Waist circumference [14 months]

2. To evaluate the safety and tolerability of CP 945,598 urine and blood tests [14 months]

3. To explore the effect of CP 954, 598 on: Pharmacodynamic measurements including fasting insulin, fasting plasma glucose, adiponectin [14 months]

4. To explore the effect of CP 954, 598 on: Patient reported outcomes: Power of Food Scale and Three factor Eating Scale [14 months]

5. To explore the effect of CP 954, 598 GAD 7 and PHQ 9 self report questionnaires. and C-SSRS semi structured interview [14 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	La Jolla	California	United States	92037
2	Pfizer Investigational Site	Denver	Colorado	United States	80220
3	Pfizer Investigational Site	Baton Rouge	Louisiana	United States	70808
4	Pfizer Investigational Site	Boston	Massachusetts	United States	02118
5	Pfizer Investigational Site	St. Louis	Missouri	United States	63110
6	Pfizer Investigational Site	New York	New York	United States	10021-7903
7	Pfizer Investigational Site	Durham	North Carolina	United States	27710
8	Pfizer Investigational Site	Philadelphia	Pennsylvania	United States	19104
9	Pfizer Investigational Site	Seattle	Washington	United States	98108
10	Pfizer Investigational Site	Camperdown	New South Wales	Australia	2050
11	Pfizer Investigational Site	Kippa Ring	Queensland	Australia	4021
12	Pfizer Investigational Site	Adelaide	South Australia	Australia	5000
13	Pfizer Investigational Site	Bedford Park	South Australia	Australia	5042
14	Pfizer Investigational Site	Heidelberg	Victoria	Australia	3081
15	Pfizer Investigational Site	Aarhus		Denmark	8000
16	Pfizer Investigational Site	Frederiksberg C		Denmark	1958
17	Pfizer Investigational Site	Gentofte		Denmark	2820
18	Pfizer Investigational Site	Roskilde		Denmark	4000
19	Pfizer Investigational Site	Almere		Netherlands	1311 RL
20	Pfizer Investigational Site	Amsterdam		Netherlands	1081 HV
21	Pfizer Investigational Site	Amsterdam		Netherlands	1105 AZ
22	Pfizer Investigational Site	Hilversum		Netherlands	1213 RH
23	Pfizer Investigational Site	Cape Town	Gauteng	South Africa	7708
24	Pfizer Investigational Site	Johannesburg	Gauteng	South Africa	7500
25	Pfizer Investigational Site	Pretoria	Gauteng	South Africa	0157
26	Pfizer Investigational Site	Pretoria		South Africa

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00483171
• Other Study ID Numbers: A5351028
• First Posted: Jun 6, 2007
• Last Update Posted: Nov 7, 2012
• Last Verified: Nov 1, 2012

Study Results

No Results Posted as of Nov 7, 2012