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NCT Number: NCT07446439

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

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.

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Key information

Conditions

Nausea and Vomiting Body Weight Nausea Nutrition Disorders Nutritional and Metabolic Diseases Obesity 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 3

Primary location

Vanda Investigational Site, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Tradipitant

Drug

Oral Capsule

Other names: Nereus, VLY-686

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 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.

Secondary outcomes

  1. Proportion of participants with worst nausea severity score ≥ 3 and at least one vomiting episode over 1 week.

    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 their vomiting frequency in a 24-hour period.

  2. 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

    Nausea 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Vanda Pharmaceuticals

CONTACT

[email protected]

(202) 734-3400

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Apr 20, 2026

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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