NL-OMON51000已完成2 期
A Phase II, randomized, double blind, parallel group,46 weeks dose-finding study of BI 456906 administered once weekly subcutaneously compared with placebo in patients with obesity or overweight - Combined PhIIa/b in Obesity
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Adult >= 18 years and < 75 years of age at screening
- •2. Written informed consent
- •3. Obesity or Overweight defined as BMI >=27 kg/m2 at screening
- •4. A minimum absolute body weight of 70 kg for females and 80 kg for males at
- •5. Male or female participants. Women of childbearing potential must be willing
- •and able to use two forms of effective contraception
- •6. Patients must have undergone at least one previous unsuccessful nonsurgical
- •weight-loss attempt per investigator*s judgement
排除标准
- •1. Body weight change of over +/- 5% or more in the past 12 weeks prior to
- •randomization. There must be documentation of weight in the past 12 weeks
- •before randomization.
- •2. Obesity induced by an endocrinologic disorder (e.g. Cushing Syndrome)
- •3. A HbA1c >= 6.5% at screening or diagnosed with type 1 or type 2 diabetes
- •4. Exposure to GLP-1Ra based therapies within three months prior to screening
- •Further criteria apply.
研究者
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