Safety, Toleration and Efficacy of CP-741,952 for the Treatment of Obesity

A 12-Week, Phase 2A, Randomized, Subject And Investigator Blind, Placebo-Controlled Trial To Evaluate The Effect Of CP-741,952 On Weight Loss In Otherwise Healthy Overweight And Obese Adult Subjects

Patrocinadores

Patrocinador principal: Pfizer

Fuente Pfizer
Resumen breve

The purpose of this study is to determine whether CP-741,952 is effective in the treatment of obesity and to determine 12 week safety and toleration.

Descripción detallada

Following review of the preliminary data from completed study A7081004, the development program for CP-741,952 was terminated on 15 March 2007. Primary reasons for program termination included a lack of significant efficacy at all doses investigated and an increased incidence of mild to moderate elevations in serum transaminases, primarily alanine aminotransferase (ALT), and liver fat content, in treated compared to placebo subjects. A synopsis will be created and will include greater detail on these findings.

Estado general Terminated
Fecha de inicio June 2006
Fecha de Terminación April 2007
Fase Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Weight Loss, toleration, safety
Resultado secundario
Medida Periodo de tiempo
Waist Circumference, serum lipids
Inscripción 100
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: CP-741,952

Elegibilidad

Criterios:

Inclusion Criteria:

- BMI of 30-40 kg/m2

Exclusion Criteria:

- Women of childbearing potential

Género: All

Edad mínima: 18 Years

Edad máxima: 65 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Pfizer CT.gov Call Center Study Director Pfizer
Ubicación
Instalaciones:
Pfizer Investigational Site | Ann Arbor, Michigan, 48105, United States
Pfizer Investigational Site | Kalamazoo, Michigan, 49007, United States
Pfizer Investigational Site | New York, New York, 10021-7903, United States
Pfizer Investigational Site | Charlotte, North Carolina, 28211, United States
Pfizer Investigational Site | San Antonio, Texas, 78229, United States
Ubicacion Paises

United States

Fecha de verificación

July 2011

Condición Examinar
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Single

Fuente: ClinicalTrials.gov