A Study to Evaluate Tradipitant on Treating Nausea and Vomiting Induced by GLP-1R Agonist Use
Recruiting · NCT07446439 · Interventional (participants receive a specific treatment) · Lead sponsor: Vanda Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboTradipitant
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
10 locations listed across 6 US states.
- Vanda Investigational Site - Los Angeles, California, United States
- Vanda Investigational Site - San Diego, California, United States
- Vanda Investigational Site - San Jose, California, United States
- Vanda Investigational Site - Tampa, Florida, United States
- Vanda Investigational Site - Hamilton, New Jersey, United States
- Vanda Investigational Site - New York, New York, United States
- Vanda Investigational Site - Syosset, New York, United States
- Vanda Investigational Site - Plano, Texas, United States
- Vanda Investigational Site - San Antonio, Texas, United States
- Vanda Investigational Site - Burke, Virginia, United States