NCT07446439 A Study to Evaluate Tradipitant on Treating Nausea and Vomiting Induced by GLP-1R Agonist Use
| NCT ID | NCT07446439 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Vanda Pharmaceuticals |
| Condition | Nausea and Vomiting |
| Study Type | INTERVENTIONAL |
| Enrollment | 280 participants |
| Start Date | 2026-03-27 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 280 participants in total. It began in 2026-03-27 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Vanda Pharmaceuticals Inc.
STUDY DIRECTOR
Vanda Pharmaceuticals Inc.
Frequently Asked Questions
Who can join the NCT07446439 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Nausea and Vomiting. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07446439 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 280 participants.
Is NCT07446439 currently recruiting?
Yes, NCT07446439 is actively recruiting participants. Contact the research team at clinicaltrials@vandapharma.com for enrollment information.
Where is the NCT07446439 trial being conducted?
This trial is being conducted at Los Angeles, United States, San Diego, United States, San Jose, United States, Tampa, United States and 6 additional locations.
Who is sponsoring the NCT07446439 clinical trial?
NCT07446439 is sponsored by Vanda Pharmaceuticals. The principal investigator is Vanda Pharmaceuticals Inc. at Vanda Pharmaceuticals Inc.. The trial plans to enroll 280 participants.