A Randomized, Open-Label, Parallel Group, Fixed Energy Deficit Methodology Trial to Characterize Early Efficacy Biomarkers During Treatment of Obesity in Adult, Obese, Male Subjects.

Pfizer3 个研究点分布在 1 个国家目标入组 57 人开始时间: 2006年10月最近更新: 2009年3月23日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Pfizer
入组人数: 57
试验地点: 3
主要终点: To evaluate the effect of varying degrees of controlled, 1-month, caloric restriction on weight loss, and response of known circulating, candidate biomarkers

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Methods study to characterize early indicators of weight loss in people.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: Male
接受健康志愿者: 否

入选标准

•Subjects >=18 years of age with BMI >= 30 and < 40 kg/m2

排除标准

•Females, those with illnesses expected to cause weight loss, those without stable body weight within 3 months of screening.

结局指标

主要结局

To evaluate the effect of varying degrees of controlled, 1-month, caloric restriction on weight loss, and response of known circulating, candidate biomarkers

时间窗: Throughout trial

次要结局

To evaluate the time course, magnitude and biomarkers of metabolic compensation as well as assessment of well being (via questionnaires) following varying degrees of controlled, 1-month, caloric restriction(Throughout trial)

研究者

发起方

Pfizer

申办方类型

Industry

研究点 (3)

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