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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Drug: CP-945,598
* Behavioral: Non-pharmacological weight loss program (NPP)
* Behavioral: Low Calorie Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: CP-945,598<br>* CP-945,598<br>|
| Other: Non-pharmacological weight loss program (NPP)<br> | Behavioral: Non-pharmacological weight loss program (NPP)<br>* Nutrition counseling, exercise monitoring and behavioral management will occur for all arms during the NPP.<br>|
| Other: Low Calorie Diet<br> | Behavioral: Low Calorie Diet<br>* Low calorie diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore the effect of CP 954, 598 on: Waist circumference |  | 14 months | 
| To evaluate the safety and tolerability of CP 945,598 urine and blood tests |  | 14 months | 
| To explore the effect of CP 954, 598 on: Pharmacodynamic measurements including fasting insulin, fasting plasma glucose, adiponectin |  | 14 months | 
| To explore the effect of CP 954, 598 on: Patient reported outcomes: Power of Food Scale and Three factor Eating Scale |  | 14 months | 
| To explore the effect of CP 954, 598 GAD 7 and PHQ 9 self report questionnaires. and C-SSRS semi structured interview |  | 14 months |