Actively Recruiting
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
Led by Vanda Pharmaceuticals · Updated on 2026-04-20
280
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Tradipitant on treating nausea and vomiting caused by GLP-1 receptor agonist use in adults who are overweight or have class I or II obesity. This phase 3, randomized, placebo-controlled study includes healthy volunteers without serious medical issues or diabetes. The goal is to better understand how Tradipitant impacts these symptoms compared to a placebo. Participants will be randomly assigned to receive either Tradipitant or a placebo, both given as oral capsules twice daily for about two weeks. The study has two treatment arms: one receiving Tradipitant and the other receiving a placebo. The study uses quadruple masking to ensure unbiased results. During the study, participants will record nausea and vomiting symptoms daily in a symptom diary. Researchers will measure the proportion of participants experiencing vomiting episodes and assess nausea severity over one week. The study will monitor safety and side effects throughout, with the total participation duration around two weeks of treatment.
CONDITIONS
Brief Title
A Study to Evaluate Tradipitant on Treating Nausea and Vomiting Induced by GLP-1R Agonist Use
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body Mass Index 25 and < 40 kg/m�b2
- No serious medical problems or chronic diseases, specifically no type I or type II diabetes
- Adults aged 18 to 65 years
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks
Participants receive either tradipitant or placebo orally twice daily to treat nausea and vomiting induced by GLP-1R agonist use.
Multiple visits during treatment period
Trial Site Locations
Total: 10 locations
1
Vanda Investigational Site
Los Angeles, California, United States, 90025
Actively Recruiting
2
Vanda Investigational Site
San Diego, California, United States, 92108
Actively Recruiting
3
Vanda Investigational Site
San Jose, California, United States, 95124
Not Yet Recruiting
4
Vanda Investigational Site
Tampa, Florida, United States, 33613
Actively Recruiting
5
Vanda Investigational Site
Hamilton, New Jersey, United States, 08690
Not Yet Recruiting
6
Vanda Investigational Site
New York, New York, United States, 10016
Not Yet Recruiting
7
Vanda Investigational Site
Syosset, New York, United States, 11791
Not Yet Recruiting
8
Vanda Investigational Site
Plano, Texas, United States, 75024
Not Yet Recruiting
9
Vanda Investigational Site
San Antonio, Texas, United States, 78215
Not Yet Recruiting
10
Vanda Investigational Site
Burke, Virginia, United States, 22015
Not Yet Recruiting
Research Team
V
Vanda Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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