DelfaGLP-1 Atlas

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RecruitingPhase 3

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

The Thetis Study: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Tradipitant on Nausea and Vomiting After GLP-1R Agonist Administration in Healthy Overweight or Obese Volunteers

Asset

Semaglutide

GLP-1 agonist

Listed sites

10

Recruiting sites

3

Enrollment

280

estimated

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 IDNCT07446439
Org study IDVP-VLY-686-3601

Timeline

Milestones

Study first posted2026-03-03actual
Study start2026-03-27actual
Last update posted2026-04-20actual
Primary completion2026-12-01estimated
Study completion2026-12-01estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

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

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

Proportion of participants with worst nausea severity score ≥ 3 and at least one vomiting episode over 1 week.

Time frame:1 week

threshold achievement, event

componentsNausea, Vomiting

Secondary/protocol endpoint

To evaluate the effect of tradipitant relative to placebo on the worst of 7 daily nausea severity scores over 1 week.

Time frame:1 week

Nausea

descriptive

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.