The Thetis Study: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Tradipitant on Nausea and Vomiting After GLP-1R Agonist Administration in Healthy Overweight or Obese Volunteers
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 10
- 主要终点
- Proportion of participants with at least 1 vomiting episode per week in the tradipitant group compared to the placebo group as measured by a daily symptom diary.
研究概览
简要总结
The goal of this study is to measure the effects of using Tradipitant to treat nausea and vomiting induced by GLP-1R agonist use in adults with class I or class II obesity, or adults who are overweight with at least one weight-related condition. The study is placebo-controlled with two treatment arms.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index ≥ 25 and < 40 kg/m^2
- •No serious medical problems or chronic diseases, specifically no type I or type II diabetes
排除标准
- •Another disorder that contributes to gastrointestinal symptoms
- •History of intolerance and/or hypersensitivity to NK-1 receptor antagonists
- •History of intolerance and/or hypersensitivity to GLP-1 receptor agonists
- •Exposure to any investigational medication within the past 60 days
研究组 & 干预措施
Placebo Group
Treatment with placebo BID for approximately 2 weeks
干预措施: Placebo (Drug)
Tradipitant Group
Treatment with tradipitant BID for approximately 2 weeks
干预措施: Tradipitant (Drug)
结局指标
主要结局
Proportion of participants with at least 1 vomiting episode per week in the tradipitant group compared to the placebo group as measured by a daily symptom diary.
时间窗: 1 week
A questionnaire called the Nausea Vomiting Daily Diary (NV-DD) will be completed once a day, which will be used to collect data for this endpoint. The NV-DD asks participants to record their vomiting frequency in a 24-hour period.
次要结局
- Proportion of participants with worst nausea severity score ≥ 3 and at least one vomiting episode over 1 week.(1 week)
- To evaluate the effect of tradipitant relative to placebo on the worst of 7 daily nausea severity scores over 1 week.(1 week)