RecruitingPhase 3NCT07446439

A Study to Evaluate Tradipitant on Treating Nausea and Vomiting Induced by GLP-1R Agonist Use

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


Sponsor

Vanda Pharmaceuticals

Enrollment

280 participants

Start Date

Mar 27, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

  • 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 Criteria4

  • 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

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Interventions

DRUGTradipitant

Oral Capsule

DRUGPlacebo

Oral Capsule


Locations(10)

Vanda Investigational Site

Los Angeles, California, United States

Vanda Investigational Site

San Diego, California, United States

Vanda Investigational Site

San Jose, California, United States

Vanda Investigational Site

Tampa, Florida, United States

Vanda Investigational Site

Hamilton, New Jersey, United States

Vanda Investigational Site

New York, New York, United States

Vanda Investigational Site

Syosset, New York, United States

Vanda Investigational Site

Plano, Texas, United States

Vanda Investigational Site

San Antonio, Texas, United States

Vanda Investigational Site

Burke, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT07446439


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