Tradipitant for GLP-1R agonist–related nausea and vomiting in adults with overweight or class I–II obesity
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
This trial will test if tradipitant can reduce nausea and vomiting caused by GLP-1 receptor agonist weight-loss medicines in adults who are overweight or have class I–II obesity.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Vanda Pharmaceuticals Industry-sponsored |
| Locations | 10 sites (Los Angeles, California and 9 other locations) |
| Trial ID | NCT07446439 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with BMI 25 to <40 kg/m2 who are taking a GLP-1R agonist and experiencing nausea or vomiting, without diabetes, other significant chronic illnesses, or contraindications to NK‑1 receptor antagonists.
Not a fit: Patients with type 1 or type 2 diabetes, preexisting gastrointestinal disorders that cause symptoms, or a history of hypersensitivity to GLP-1 or NK‑1 receptor antagonists are unlikely to benefit or may be ineligible.
Why it matters
Potential benefit: If successful, tradipitant could reduce GLP-1–related nausea and vomiting and improve tolerability and continued use of GLP-1 weight‑loss medications.
How similar studies have performed: NK‑1 receptor antagonists are well established for chemotherapy-related nausea and early-phase data and case reports suggest potential benefit for GLP-1–induced nausea, but large phase‑3 evidence is currently limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California and 9 other locations
- Vanda Investigational Site — Los Angeles, California, United States (Recruiting)
- Vanda Investigational Site — San Diego, California, United States (Recruiting)
- Vanda Investigational Site — San Jose, California, United States (Not_yet_recruiting)
- Vanda Investigational Site — Tampa, Florida, United States (Recruiting)
- Vanda Investigational Site — Hamilton, New Jersey, United States (Not_yet_recruiting)
- Vanda Investigational Site — New York, New York, United States (Not_yet_recruiting)
- Vanda Investigational Site — Syosset, New York, United States (Not_yet_recruiting)
- Vanda Investigational Site — Plano, Texas, United States (Not_yet_recruiting)
- Vanda Investigational Site — San Antonio, Texas, United States (Not_yet_recruiting)
- Vanda Investigational Site — Burke, Virginia, 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.