A Study to Evaluate Tradipitant on Treating Nausea and Vomiting Induced by GLP-1R Agonist Use
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tradipitant, Placebo.
- Who it may be relevant to
- Registry conditions: Nausea and Vomiting, Obesity. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug Tradipitant
Oral Capsule - Drug Placebo
Oral Capsule
Primary outcome measures
- Proportion of participants with at least 1 vomiting episode per week in the tradipitant group compared to the placebo group as measured by a daily symptom diary. [Time frame: 1 week]
Secondary outcome measures (2)
- Proportion of participants with worst nausea severity score ≥ 3 and at least one vomiting episode over 1 week. [Time frame: 1 week]
- To evaluate the effect of tradipitant relative to placebo on the worst of 7 daily nausea severity scores over 1 week. [Time frame: 1 week]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 10 centers
- Vanda Investigational Site — Los Angeles
- Vanda Investigational Site — San Diego
- Vanda Investigational Site — San Jose
- Vanda Investigational Site — Tampa
- Vanda Investigational Site — Hamilton
- Vanda Investigational Site — New York
- Vanda Investigational Site — Syosset
- Vanda Investigational Site — Plano
- … and 2 more centers
Identifiers
NCT: NCT07446439 · VP-VLY-686-3601