Pharmacokinetics, Safety, Tolerability and Efficacy of Intravenous Doses of ZGN-433 in Obese Female Volunteers

Phase 1b Trial of Beloranib, a Novel Methionine Aminopeptidase 2 (MetAP-2) Inhibitor for Treatment of Extreme Obesity: Randomized, Double-Blind, Placebo-Controlled, Escalating Doses in Female Volunteers

Patrocinadores

Patrocinador principal: Zafgen, Inc.

Fuente Zafgen, Inc.
Resumen breve

The purpose of this study is to assess whether multiple doses of ZGN-433 are safe and effective.

Descripción detallada

This protocol is designed to test the safety and efficacy of a drug called Beloranib (ZGN-433). It is to be tested for its ability to reduce weight in obese female subjects who are of non-childbearing potential. The study will provide information on how much ZGN-433 gets into the blood, how long it stays in the body, and how it affects other biological markers.

Estado general Completed
Fecha de inicio June 2011
Fecha de Terminación November 2011
Fecha de finalización primaria November 2011
Fase Phase 1
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Demonstrate safe doses of ZGN-433 for reduction of body weight in obese female volunteers. Approximately 4 weeks
Resultado secundario
Medida Periodo de tiempo
Incidence, severity and dose-relationship of adverse events as well as changes in physical examinations, ECGs, vital signs and/or laboratory evaluations as a measure of safety and tolerability. Approximately 4 weeks
Peak plasma concentration of ZGN-433 to assess relationship to weight loss. Approximately 4 weeks
Elimination half-life of ZGN-433 to assess relationship to weight loss. Approximately 4 weeks
Inscripción 25
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: ZGN-433

Descripción: Subjects will receive placebo or ZGN-433 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.

Etiqueta de grupo de brazo: ZGN-433

Otro nombre: Beloranib

Tipo de intervención: Drug

Nombre de intervención: Normal Saline

Descripción: Subjects will receive placebo or ZGN-433 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.

Etiqueta de grupo de brazo: Normal Saline

Elegibilidad

Criterios:

Inclusion Criteria:

- Obese but otherwise healthy females

- Non-childbearing potential (surgically sterile, post-menopausal, or receiving implanted or injectable contraceptive for at least 3 months)

- BMI ≥ 30 and ≤ 50 kg/m2

- Stable body weight during the past month

Exclusion Criteria:

- Use of weight loss agents in the past month

- History of eating disorder

- History of gastric bypass surgery

- Current smokers

Género: Female

Edad mínima: 18 Years

Edad máxima: 60 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
J K Marjason, MD Principal Investigator Q-Pharm Clinics, Royal Brisbane and Women's Hospital
Ubicación
Instalaciones: Q-Pharm Clinics, Royal Brisbane and Women's Hospital
Ubicacion Paises

Australia

Fecha de verificación

December 2011

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Normal Saline

Tipo: Placebo Comparator

Etiqueta: ZGN-433

Tipo: Experimental

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Fuente: ClinicalTrials.gov