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

Phase 3RecruitingNCT07446439

Vanda Pharmaceuticals280 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

280

Conditions

Nausea and Vomiting Obesity

Interventions

TradipitantDRUG

Oral Capsule

PlaceboDRUG

Oral Capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (10)

Vanda Investigational Site

Los Angeles, California, United States

RECRUITING

Vanda Investigational Site

San Diego, California, United States

RECRUITING

Outcomes

Primary Outcomes

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

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

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

Central Contacts

Vanda Pharmaceuticals

CONTACT

(202) 734-3400 clinicaltrials@vandapharma.com

Data from ClinicalTrials.gov

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