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

Phase 3

Terminated

• Conditions: Obesity
• Interventions: Drug: CP-945,598; Behavioral: Non-pharmacological weight loss program (NPP); Behavioral: Low Calorie Diet

• Registration Number: NCT00483171
• Lead Sponsor: Pfizer

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.

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 Timeline

• Study First Submitted: 2007-06-04
• Study First Submitted QC: 2007-06-04
• Study First Posted: 2007-06-06
• Study Start: 2008-01
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Disposition First Submitted: 2009-08-11
• Disposition First Submitted QC: 2009-08-11
• Disposition First Posted: 2009-08-13
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-05
• Last Update Posted: 2012-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 699

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	CP-945,598	-
Non-pharmacological weight loss program (NPP)	Non-pharmacological weight loss program (NPP)	-
Low Calorie Diet	Low Calorie Diet	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇿🇦 Pretoria, South Africa