A Study to Measure the Effects of Using Tradipitant on Nausea and Vomiting After GLP-1R Agonist Use
A Proof of Concept, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Tradipitant on Nausea and Vomiting After GLP-1R Agonist Administration in Healthy Overweight Class I or Class II Obese Volunteers
1 other identifier
interventional
124
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 obesity
Started Feb 2025
Shorter than P25 for phase_2 obesity
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2025
CompletedFirst Posted
Study publicly available on registry
February 3, 2025
CompletedStudy Start
First participant enrolled
February 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2025
CompletedNovember 12, 2025
November 1, 2025
7 months
January 9, 2025
November 7, 2025
Conditions
Keywords
Outcome Measures
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 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.
1 week
Secondary Outcomes (2)
Individual gastrointestinal symptoms
1 week
Safety and tolerability of tradipitant after administration of semaglutide as measured by spontaneous reporting of adverse events (AEs)
2 weeks
Study Arms (2)
Placebo Group
PLACEBO COMPARATORTreatment with placebo BID for approximately 2 weeks
Tradipitant Group
EXPERIMENTALTreatment with tradipitant BID for approximately 2 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Body Mass Index 25-40 kg/m\^2 inclusive
- No serious medical problems or chronic diseases, specifically no type I or type II diabetes
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Vanda Investigational Site
Los Angeles, California, 90025, United States
Vanda Investigational Site
Rochester, Minnesota, 55905, United States
Vanda Investigational Site
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Vanda Pharmaceuticals
Vanda Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2025
First Posted
February 3, 2025
Study Start
February 25, 2025
Primary Completion
October 6, 2025
Study Completion
October 6, 2025
Last Updated
November 12, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share