A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients
19 de marzo de 2015 actualizado por: AstraZeneca
This is a multicenter study designed to compare the effect of exenatide plus a lifestyle modification plan versus placebo plus a lifestyle modification plan on weight loss in non-diabetic, obese subjects.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
163
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Arizona
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Peoria, Arizona, Estados Unidos
- Research Site
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Tucson, Arizona, Estados Unidos
- Research Site
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California
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Santa Ana, California, Estados Unidos
- Research Site
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Indiana
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Indianapolis, Indiana, Estados Unidos
- Research Site
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Kansas
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Topeka, Kansas, Estados Unidos
- Research Site
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Wichita, Kansas, Estados Unidos
- Research Site
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos
- Research Site
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Missouri
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St. Louis, Missouri, Estados Unidos
- Research Site
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos
- Research Site
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South Carolina
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Goose Creek, South Carolina, Estados Unidos
- Research Site
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Spartanburg, South Carolina, Estados Unidos
- Research Site
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Texas
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Dallas, Texas, Estados Unidos
- Research Site
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San Antonio, Texas, Estados Unidos
- Research Site
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Washington
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Renton, Washington, Estados Unidos
- Research Site
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Ponce, Puerto Rico
- Research Site
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San Juan, Puerto Rico
- Research Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Have a Body Mass Index (BMI) >= 30kg/m^2
Exclusion Criteria:
- Have ever participated in this study previously, or any other study using exenatide (AC2993/LY2148568) or GLP-1 analogs
- Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start (this criterion includes drugs that have not received regulatory approval for any indication at the time of study entry)
- Diagnosis of diabetes mellitus (other than gestational diabetes), or previous use of anti-diabetic medications for > 3 months
- Have had a change in prescribed lipid-lowering or blood pressure agents within 4 weeks of screening
- Used drugs for weight loss (e.g., Xenical [orlistat], Meridia [sibutramine], Acutrim [phenylpropanolamine], Accomplia [rimonabant], Alli [low-dose orlistat], or other similar over-the-counter weight loss remedies or medications) within 3 months of screening
- Are actively participating in, or have participated in a formal weight loss program within the last 3 months
- Have a history of chronic use of drugs that directly affect gastrointestinal motility, including, but not limited to Reglan (metoclopramide) and chronic macrolide antibiotics
- Have been treated with any anti-diabetic medications within 3 months of screening
- Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to study start
- Have had bariatric surgery
- Have had an organ transplant
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Grupo A
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inyección subcutánea (5 mcg o 10 mcg), dos veces al día
Otros nombres:
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Comparador de placebos: Grupo B
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subcutaneous injection (equivalent volume to active dose), twice a day
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Body Weight
Periodo de tiempo: 24 weeks
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Change in body weight from baseline after 24 weeks of treatment (i.e., body weight at week 24 minus body weight at week 0)
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24 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Body Mass Index (BMI)
Periodo de tiempo: 24 weeks
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Change in BMI from baseline after 24 weeks of treatment (i.e., BMI at week 24 minus BMI at week 0)
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24 weeks
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Change in Waist-to-hip Ratio
Periodo de tiempo: 24 weeks
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Waist-to-hip ratio at week 24 compared to waist-to-hip ratio at week 0 (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0).
Waist-to-hip ratio equals waist circumference at given time point divided by hip circumference at given timepoint.
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24 weeks
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Percentage of Patients Experiencing >=5% Weight Loss
Periodo de tiempo: 24 weeks
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Percentage of exenatide and placebo treated patients experiencing >=5% weight loss after 24 weeks of treatment (i.e., [weight at week 0 minus weight at week 24] divided by weight at week 0 times 100% >=5%)
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24 weeks
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Change in Total Cholesterol
Periodo de tiempo: 24 weeks
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Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0)
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24 weeks
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Change in High Density Lipoprotein (HDL) Cholesterol
Periodo de tiempo: 24 weeks
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Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0)
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24 weeks
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Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed)
Periodo de tiempo: 24 weeks
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Ratio of triglycerides at week 24 compared to triglycerides at week 0 (i.e., triglycerides at week 24 divided by triglycerides at week 0)
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24 weeks
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Change in Low Density Lipoprotein (LDL) Cholesterol
Periodo de tiempo: 24 weeks
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Change in LDL cholesterol from baseline following 24 weeks of treatment (i.e., LDL cholesterol at week 24 minus LDL cholesterol at week 0)
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24 weeks
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Change in Fasting Serum Glucose
Periodo de tiempo: 24 weeks
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Change in fasting serum glucose from baseline following 24 weeks of treatment (i.e., fasting serum glucose at week 24 minus fasting serum glucose at week 0)
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24 weeks
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Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT)
Periodo de tiempo: 24 weeks
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Change in serum glucose AUC following OGTT (week 24 compared to week 0) (i.e., serum glucose AUC at week 24 minus serum glucose AUC at week 0)
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24 weeks
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Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Beta Cell (HOMA-B) (Logarithmically Transformed)
Periodo de tiempo: 24 weeks
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Ratio of HOMA-B at week 24 to HOMA-B at week 0 (i.e., HOMA-B at week 24 divided by HOMA-B at week 0).
HOMA-B is a measure of beta cell function.
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24 weeks
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Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) (Logarithmically Transformed)
Periodo de tiempo: 24 weeks
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Ratio of HOMA-S at week 24 to HOMA-S at week 0 (i.e., HOMA-S at week 24 divided by HOMA-S at week 0).
HOMA-S is a measure of insulin sensitivity.
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24 weeks
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Incidence of Patients That Demonstrate Overt Signs of Diabetes Mellitus Diagnosis
Periodo de tiempo: 24 weeks
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Number of patients in each treatment group that demonstrate overt signs of diabetes mellitus diagnosis by week 24
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24 weeks
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Incidence of Patients That Demonstrate Normalization of Impaired Fasting Glucose (IFG) and/or Impaired Glucose Tolerance (IGT)
Periodo de tiempo: 24 weeks
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Number of patients in each treatment group that demonstrate normalization of IFG and/or IGT by week 24
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24 weeks
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Change in High Sensitivity C-reactive Protein (hsCRP)
Periodo de tiempo: 24 weeks
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Change in hsCRP levels from baseline following 24 weeks of treatment (i.e., hsCRP at week 24 minus hsCRP at week 0)
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24 weeks
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Change in Glycosylated Hemoglobin (HbA1c)
Periodo de tiempo: 24 weeks
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Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)
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24 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Director de estudio: James Malone, MD, Eli Lilly and Company
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2007
Finalización primaria (Actual)
1 de febrero de 2008
Finalización del estudio (Actual)
1 de febrero de 2008
Fechas de registro del estudio
Enviado por primera vez
10 de julio de 2007
Primero enviado que cumplió con los criterios de control de calidad
10 de julio de 2007
Publicado por primera vez (Estimar)
12 de julio de 2007
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
7 de abril de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
19 de marzo de 2015
Última verificación
1 de marzo de 2015
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- H8O-MC-GWBP
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .