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

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Obesity

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00483171

A5351028

Details and patient eligibility

About

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

Full 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.

Enrollment: 699 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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699 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: CP-945,598

Non-pharmacological weight loss program (NPP)

Other group

Treatment:

Behavioral: Non-pharmacological weight loss program (NPP)

Low Calorie Diet

Other group

Treatment:

Behavioral: Low Calorie Diet