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
Vanda Pharmaceuticals
Summary
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Body Mass Index ≥ 25 and \< 40 kg/m\^2 * No serious medical problems or chronic diseases, specifically no type I or type II diabetes Exclusion Criteria: * 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
Interventions
- DrugTradipitant
Oral Capsule
- DrugPlacebo
Oral Capsule
Locations (10)
- Vanda Investigational SiteLos Angeles, California
- Vanda Investigational SiteSan Diego, California
- Vanda Investigational SiteSan Jose, California
- Vanda Investigational SiteTampa, Florida
- Vanda Investigational SiteHamilton, New Jersey
- Vanda Investigational SiteNew York, New York