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NCT Number: NCT06804603

A Study to Measure the Effects of Using Tradipitant on Nausea and Vomiting After GLP-1R Agonist Use

The goal of this study is to measure the effects of using Tradipitant after GLP-1R agonist use on nausea and vomiting in healthy overweight, class I, or class II obese volunteers. The study is placebo-controlled with two treatment arms.

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Key information

Conditions

Obesity Body Weight Nausea Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vanda Investigational Site, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body Mass Index 25-40 kg/m^2 inclusive
  • 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

Treatment and study plan

Tradipitant

Drug

Oral capsule

Placebo

Drug

Oral capsule

Primary outcomes

  1. 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

    A daily diary called the Nausea Vomiting Daily Diary (NV-DD) will be used. The NV-DD asks participants to rate their nausea symptoms on a Likert scale from 0-5 (0=none, 5= very severe), as well as record the duration of nausea and vomiting frequency.

Secondary outcomes

  1. Individual gastrointestinal symptoms

    Time frame: 1 week

    Nausea and vomiting symptoms will be assessed using the NV-DD. The NV-DD asks participants to rate their nausea symptoms on a Likert scale from 0-5 (0=none, 5= very severe), as well as record the duration of nausea and vomiting frequency.

  2. Safety and tolerability of tradipitant after administration of semaglutide as measured by spontaneous reporting of adverse events (AEs)

    Time frame: 2 weeks

    Safety will be monitored using vital signs, blood chemistry, hematology, urology, and ECGs (QT, PR, QTcF, QTcB, QRS intervals and heart rate).

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

A Proof of Concept, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Tradipitant on Nausea and Vomiting After GLP-1R Agonist Administration in Healthy Overweight Class I or Class II Obese Volunteers

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 3, 2025
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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