NCT02075281已完成2 期
A 20-week, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial to Assess the Safety and Efficacy of HM11260C on Body Weight in Obese Subjects Without Diabetes
Hanmi Pharmaceutical Company Limited2 个研究点 分布在 1 个国家目标入组 297 人开始时间: 2014年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 297
- 试验地点
- 2
- 主要终点
- Change from baseline in body weight at 20 weeks
研究概览
简要总结
The purpose of this study is to determine the optimal dose and regimen of HM11260C, in combination with a hypocaloric diet, to reduce weight in obese subjects who are otherwise considered in stable health.
详细描述
Phase 2 study
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Age: 18 years to 65 years
- •Genders: male and female
- •healthy obese population
- •non-diabetes
- •stable body weight for at least 3 months prior to screening
排除标准
- •Pregnant or nursing (lactating) women
- •Drug-induced obesity
- •Diabetes mellitus (type 1, 2, and other)
- •Previous surgical treatment for obesity
- •Any known history of severe gastrointestinal (GI) disease or intolerance
- •Known history of pancreatitis with presence of raised serum amylase and lipase
- •History of suicide attempts or recent history (within 2 years prior to screening) of major depression, anxiety, or other psychiatric disease requiring treatment with prescription medication including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitor s (SNRIs), antipsychotics, and lithium.
结局指标
主要结局
Change from baseline in body weight at 20 weeks
时间窗: 20 weeks from baseline
次要结局
- Number of participants with adverse event(during 20 weeks of treatment and follow-up period)
- Change from baseline in blood lipid profile (e.g., cholesterol, and LDL-C level) at 20 week(20 weeks from baseline)
- Change from baseline in HbA1c and fasting plasma glucose level at 20 week(20 weeks from baseline)
研究者
研究点 (2)
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