Effect of 2-year Administration of CP-945,598 on Weight Loss Efficacy and Safety.

A 2-Year, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study To Evaluate The Long-Term Efficacy And Safety Of CP-945,598 In The Treatment Of Obese Subjects

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00396448

Enrollment

1253

Registered

2006-11-07

Start date

2007-02-28

Completion date

2009-02-28

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 examine the long-term weight loss and safety of CP-945,598 in obese adults

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 Treatment B

Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.

DRUGCP-945,598 Treatment A

Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.

DRUGPlacebo

Subjects receive placebo plus dietary, physical activity, and behavioral counseling.

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

* Obese adults with a body mass index \> or = 30 kg/m ; \> or = 27 kg/m2 for those with obesity-related comorbidities including hypertension and dyslipidemia

Exclusion criteria

* Pregnancy * Diabetes * Adults with serious or unstable current or past medical conditions

Design outcomes

Primary

Measure	Time frame
Change in body weight and proportion of subjects with 5% weight loss	1 year

Secondary

Measure	Time frame
Waist circumference, blood lipids and glucose, prevalence of metabolic syndrome, patient reported outcomes, population PK	1-2 years

Countries

Argentina, Australia, Chile, France, Germany, Mexico, South Korea, Spain, Sweden, United Kingdom, United States

Outcome results

None listed

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