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

Phase 3TerminatedNCT00483171

Pfizer699 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

699

Conditions

Obesity

Interventions

CP-945,598DRUG

CP-945,598

Non-pharmacological weight loss program (NPP)BEHAVIORAL

Nutrition counseling, exercise monitoring and behavioral management will occur for all arms during the NPP.

Low Calorie DietBEHAVIORAL

Low calorie diet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (26)

Pfizer Investigational Site

La Jolla, California, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

To explore the effect of CP 954, 598 on: Waist circumference

Time frame: 14 months

To evaluate the safety and tolerability of CP 945,598 urine and blood tests

Time frame: 14 months

To explore the effect of CP 954, 598 on: Pharmacodynamic measurements including fasting insulin, fasting plasma glucose, adiponectin

Time frame: 14 months

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

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

Data from ClinicalTrials.gov

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