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

Phase 2

Recruiting

• Conditions: Obesity
• Interventions: Drug: Placebo; Drug: Tradipitant

• Registration Number: NCT06804603
• Lead Sponsor: Vanda Pharmaceuticals

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-27
• Study First Posted: 2025-02-03
• Study Start: 2025-02-25
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-10
• Primary Completion: 2025-07-06
• Study Completion: 2025-07-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	Treatment with placebo BID for approximately 2 weeks
Tradipitant Group	Tradipitant	Treatment with tradipitant BID for approximately 2 weeks

Primary Outcome Measures

Name	Time	Method
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.	1 week	A daily diary called the Nausea Vomiting Daily Diary (NV-DD) will be used. 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 record the duration of nausea and vomiting frequency.

Secondary Outcome Measures

Name	Time	Method
Individual gastrointestinal symptoms	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 record the duration of nausea and vomiting frequency.
Safety and tolerability of tradipitant after administration of semaglutide as measured by spontaneous reporting of adverse events (AEs)	2 weeks	Safety will be monitored using vital signs, blood chemistry, hematology, urology, and ECGs (QT, PR, QTcF, QTcB, QRS intervals and heart rate).

Trial Locations

Locations (1)

Vanda Investigational Site; 🇺🇸 Rochester, Minnesota, United States