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

NCT07446439 · tracked via the Priya Life Science USA tracker

Sponsor

Vanda Pharmaceuticals

Phase

Phase 3

Started

2026-03-27

Last updated

2026-04-20

Condition(s) studied

Nausea and VomitingObesity

Investigational drug(s) / intervention(s)

TradipitantPlacebo

Tradipitant: Oral Capsule

Placebo: Oral Capsule

Study 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

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Accepted

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

Primary outcome measure(s)

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. — 1 week
A questionnaire called the Nausea Vomiting Daily Diary (NV-DD) will be completed once a day, which will be used to collect data for this endpoint. The NV-DD asks participants to record their vomiting frequency in a 24-hour period.

Trial sites (10)

Facility	City	Region	Status
Vanda Investigational Site	Los Angeles	California	Recruiting
Vanda Investigational Site	San Diego	California	Recruiting
Vanda Investigational Site	San Jose	California	Not Yet Recruiting
Vanda Investigational Site	Tampa	Florida	Recruiting
Vanda Investigational Site	Hamilton	New Jersey	Not Yet Recruiting
Vanda Investigational Site	New York	New York	Not Yet Recruiting
Vanda Investigational Site	Syosset	New York	Not Yet Recruiting
Vanda Investigational Site	Plano	Texas	Not Yet Recruiting
Vanda Investigational Site	San Antonio	Texas	Not Yet Recruiting
Vanda Investigational Site	Burke	Virginia	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07446439 on ClinicalTrials.gov ↗ ← All trials in the USA