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

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.

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Detailed Description

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Conditions

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Obesity

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