Tradipitant for GLP-1R agonist–related nausea and vomiting in adults with overweight or class I–II obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, randomized, placebo-controlled, two-arm trial compares oral tradipitant to placebo for treating nausea and vomiting that occur with GLP-1R agonist use. Eligible participants are adults with BMI between 25 and <40 kg/m2 who do not have type 1 or type 2 diabetes and have no other major chronic medical conditions causing gastrointestinal symptoms. Key exclusions include other disorders that explain GI symptoms, hypersensitivity to NK-1 or GLP-1 receptor antagonists, and recent exposure to investigational drugs. The study is conducted at Vanda investigational sites in California and measures changes in frequency and severity of nausea and vomiting during the treatment period.

Why it matters

Who can join: the full rules

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's running

• Vanda Investigational Site
  Los Angeles, California, United States Recruiting
• Vanda Investigational Site
  San Diego, California, United States Recruiting
• Vanda Investigational Site
  Tampa, Florida, United States Recruiting
• Vanda Investigational Site
  San Jose, California, United States Not yet recruiting
• Vanda Investigational Site
  Hamilton, New Jersey, United States Not yet recruiting
• Vanda Investigational Site
  New York, New York, United States Not yet recruiting

Study contacts

• Study coordinator: Vanda Pharmaceuticals
• Email: clinicaltrials@vandapharma.com
• Phone: (202) 734-3400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.