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

NCT ID: NCT06804603

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-25

Study Completion Date

2025-10-06

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Keywords

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GLP-1R agonist semaglutide obesity nausea vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo Group

Treatment with placebo BID for approximately 2 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral capsule

Tradipitant Group

Treatment with tradipitant BID for approximately 2 weeks

Group Type EXPERIMENTAL

Tradipitant

Intervention Type DRUG

Oral capsule

Interventions

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Tradipitant

Oral capsule

Intervention Type DRUG

Placebo

Oral capsule

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanda Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vanda Pharmaceuticals

Role: STUDY_DIRECTOR

Vanda Pharmaceuticals

Locations

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Vanda Investigational Site

Los Angeles, California, United States

Site Status

Vanda Investigational Site

Rochester, Minnesota, United States

Site Status

Vanda Investigational Site

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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VP-VLY-686-2601

Identifier Type: -

Identifier Source: org_study_id