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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00483171

Enrollment

699

Registered

2007-06-06

Start date

2008-01-31

Completion date

2009-01-31

Last updated

2012-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

DRUGCP-945,598

CP-945,598

BEHAVIORALNon-pharmacological weight loss program (NPP)

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

BEHAVIORALLow Calorie Diet

Low calorie diet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Australia, Denmark, Netherlands, South Africa, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026