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

April 14, 2026 updated by: Vanda Pharmaceuticals

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

280

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90025
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals
          • Phone Number: 202-734-3400
      • San Diego, California, United States, 92108
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals
          • Phone Number: 202-734-3400
      • San Jose, California, United States, 95124
        • Not yet recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals
          • Phone Number: (202) 734-3400
    • Florida
      • Tampa, Florida, United States, 33613
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals
          • Phone Number: (202) 734-3400
    • New Jersey
      • Hamilton, New Jersey, United States, 08690
        • Not yet recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals
          • Phone Number: (202) 734-3400
    • New York
      • New York, New York, United States, 10016
        • Not yet recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals
          • Phone Number: 202-734-3400
      • Syosset, New York, United States, 11791
        • Not yet recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals
          • Phone Number: (202) 734-3400
    • Texas
      • Plano, Texas, United States, 75024
        • Not yet recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals
          • Phone Number: (202) 734-3400
      • San Antonio, Texas, United States, 78215
        • Not yet recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals
          • Phone Number: (202) 734-3400
    • Virginia
      • Burke, Virginia, United States, 22015
        • Not yet recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals
          • Phone Number: (202) 734-3400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Group
Treatment with placebo BID for approximately 2 weeks
Drug: Placebo
Oral Capsule
Experimental: Tradipitant Group
Treatment with tradipitant BID for approximately 2 weeks
Drug: Tradipitant
Oral Capsule
Other Names:
  • Nereus
  • VLY-686

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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).
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanda Pharmaceuticals

Investigators

  • Study Director: Vanda Pharmaceuticals Inc., Vanda Pharmaceuticals Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VLY-686-3601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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