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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07446439

Enrollment

280

Registered

2026-03-03

Start date

2026-03-27

Completion date

2026-12-01

Last updated

2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea and Vomiting, Obesity

Keywords

GLP-1R agonist, Semaglutide, Nausea, Vomiting

Brief summary

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.

Interventions

DRUGTradipitant

Oral Capsule

DRUGPlacebo

Oral Capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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 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.

Secondary

Measure	Time frame	Description
Proportion of participants with worst nausea severity score ≥ 3 and at least one vomiting episode over 1 week.	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.
To evaluate the effect of tradipitant relative to placebo on the worst of 7 daily nausea severity scores over 1 week.	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).

Countries

United States

Contacts

CONTACTVanda Pharmaceuticals

clinicaltrials@vandapharma.com(202) 734-3400

STUDY_DIRECTORVanda Pharmaceuticals Inc.

Vanda Pharmaceuticals Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026