ClinicalTrials.gg
RecruitingNCT07446439Updated Apr 20, 2026

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

A Phase 3 interventional study of Tradipitant and Placebo in Nausea and Vomiting and Obesity, sponsored by Vanda Pharmaceuticals. Recruiting at 10 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by Vanda Pharmaceuticals · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
280
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

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.

02

Conditions studied

  • Nausea and Vomiting
  • Obesity

Keywords

  • GLP-1R agonist
  • Semaglutide
  • Nausea
  • Vomiting
03

In context

Nausea

644 studies on the registry are indexed under Nausea; 85 are open to participants now.

This study's planned enrollment of 280 is above the median of 96 across 544 interventional studies indexed under Nausea.

Browse Nausea studies →

Lead sponsor

Vanda Pharmaceuticals is the lead sponsor of 82 studies on the registry; 17 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 22 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥ 25 and \< 40 kg/m\^2
  • No serious medical problems or chronic diseases, specifically no type I or type II diabetes

Exclusion criteria

Exclusion Criteria:

  • Another disorder that contributes to gastrointestinal symptoms
  • History of intolerance and/or to NK-1 receptor antagonists
  • History of intolerance and/or hypersensitivity to GLP-1 receptor agonists
  • Exposure to any medication within the past 60 days
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
280 participants (estimated)

Study arms

  • Placebo comparator
    Placebo Group

    Treatment with placebo BID for approximately 2 weeks

    Drug: Placebo

  • Experimental
    Tradipitant Group

    Treatment with tradipitant BID for approximately 2 weeks

    Drug: Tradipitant

Interventions

  • Oral Capsule

    Also known as: Nereus, VLY-686

  • DrugPlacebo

    Oral Capsule

This study also gives Semaglutide. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

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.

    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.

    Time frame: 1 week

Secondary outcomes

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

    Time frame: 1 week

  2. To evaluate the effect of tradipitant relative to placebo on the worst of 7 daily nausea severity scores over 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).

    Time frame: 1 week

07

Study locations

3 of 10 sites recruiting
  • Vanda Investigational Site
    Los Angeles, California 90025, United States
    Recruiting
    • Vanda Pharmaceuticals · Contact202-734-3400
  • Vanda Investigational Site
    San Diego, California 92108, United States
    Recruiting
    • Vanda Pharmaceuticals · Contact202-734-3400
  • Vanda Investigational Site
    San Jose, California 95124, United States
    Not yet recruiting
    • Vanda Pharmaceuticals · Contact(202) 734-3400
  • Vanda Investigational Site
    Tampa, Florida 33613, United States
    Recruiting
    • Vanda Pharmaceuticals · Contact(202) 734-3400
  • Vanda Investigational Site
    Hamilton, New Jersey 08690, United States
    Not yet recruiting
    • Vanda Pharmaceuticals · Contact(202) 734-3400
  • Vanda Investigational Site
    New York, New York 10016, United States
    Not yet recruiting
    • Vanda Pharmaceuticals · Contact202-734-3400
  • Vanda Investigational Site
    Syosset, New York 11791, United States
    Not yet recruiting
    • Vanda Pharmaceuticals · Contact(202) 734-3400
  • Vanda Investigational Site
    Plano, Texas 75024, United States
    Not yet recruiting
    • Vanda Pharmaceuticals · Contact(202) 734-3400
  • Vanda Investigational Site
    San Antonio, Texas 78215, United States
    Not yet recruiting
    • Vanda Pharmaceuticals · Contact(202) 734-3400
  • Vanda Investigational Site
    Burke, Virginia 22015, United States
    Not yet recruiting
    • Vanda Pharmaceuticals · Contact(202) 734-3400
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07446439
Responsible party
Sponsor
First posted
Mar 3, 2026
Start date
Mar 27, 2026
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Apr 20, 2026

Study contacts

Vanda Pharmaceuticals
Contact
clinicaltrials@vandapharma.com
(202) 734-3400
Vanda Pharmaceuticals Inc.
study director · Vanda Pharmaceuticals Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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