Measuring the effects of Tradipitant on nausea and vomiting after GLP-1R agonist use
A Proof of Concept, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Tradipitant on Nausea and Vomiting After GLP-1R Agonist Administration in Healthy Overweight Class I or Class II Obese Volunteers
This study tests if Tradipitant can help reduce nausea and vomiting in healthy overweight or obese people after taking a weight loss medication.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Vanda Pharmaceuticals Industry-sponsored |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT06804603 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of Tradipitant in reducing nausea and vomiting in healthy overweight or obese individuals after the administration of GLP-1R agonists, such as semaglutide. It is a Phase 2 interventional trial that employs a placebo-controlled design with two treatment arms. Participants will be monitored for their responses to the treatment to determine the potential benefits of Tradipitant in this context.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy individuals with a Body Mass Index (BMI) between 25 and 40 kg/m² who do not have serious medical conditions.
Not a fit: Patients with gastrointestinal disorders or those who have a history of intolerance to NK-1 receptor antagonists or GLP-1 receptor agonists may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option to alleviate nausea and vomiting associated with GLP-1R agonist therapy in obese patients.
How similar studies have performed: While this approach is relatively novel, previous studies have shown that managing nausea and vomiting in obesity treatments is a significant area of interest, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Body Mass Index 25-40 kg/m\^2 inclusive * 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 this trial is running
Los Angeles, California and 1 other locations
- Vanda Investigational Site — Los Angeles, California, United States (Recruiting)
- Vanda Investigational Site — Rochester, Minnesota, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Vanda Pharmaceuticals
- Email: clinicaltrials@vandapharma.com
- Phone: (202) 734-3400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.