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CompletedPhase 2

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

Asset

Semaglutide

GLP-1 agonist

Listed sites

3

Recruiting sites

Enrollment

124

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criterion

BMI 25-40

Primary endpoint

Vomiting

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06804603
Org study IDVP-VLY-686-2601

Timeline

Milestones

Study first posted2025-02-03actual
Study start2025-02-25actual
Primary completion2025-10-06actual
Study completion2025-10-06actual
Last update posted2025-11-12actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

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.

Time frame:1 week

Vomiting

threshold achievement, event

Secondary/protocol endpoint

Individual gastrointestinal symptoms

Time frame:1 week

descriptive

Secondary/protocol endpoint

Safety and tolerability of tradipitant after administration of semaglutide as measured by spontaneous reporting of adverse events (AEs)

Time frame:2 weeks

Treatment-emergent AEs (any)

descriptive, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.