Nausea and VomitingPhase 3NCT07446439
A Study to Evaluate Tradipitant on Treating Nausea and Vomiting Induced by GLP-1R Agonist Use
A Phase 3 study testing Tradipitant in people with Nausea and Vomiting and Obesity, run by Vanda Pharmaceuticals at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nausea and Vomiting, Obesity
- What is being tested?
- Tradipitant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 10 sitesUnited States
- Study dates
- 27 Mar 2026to 1 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index ≥ 25 and < 40 kg/m^2
- No serious medical problems or chronic diseases, specifically no type I or type II diabetes
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Not yet recruiting
Vanda Investigational Site
Burke, Virginia, 22015
Vanda Pharmaceuticals, (202) 734-3400
- Not yet recruiting
Vanda Investigational Site
Hamilton, New Jersey, 08690
Vanda Pharmaceuticals, (202) 734-3400
- Recruiting
Vanda Investigational Site
Los Angeles, California, 90025
Vanda Pharmaceuticals, 202-734-3400
- Not yet recruiting
Vanda Investigational Site
New York, New York, 10016
Vanda Pharmaceuticals, 202-734-3400
- Not yet recruiting
Vanda Investigational Site
Plano, Texas, 75024
Vanda Pharmaceuticals, (202) 734-3400
- Not yet recruiting
Vanda Investigational Site
San Antonio, Texas, 78215
Vanda Pharmaceuticals, (202) 734-3400
- Recruiting
Vanda Investigational Site
San Diego, California, 92108
Vanda Pharmaceuticals, 202-734-3400
- Not yet recruiting
Vanda Investigational Site
San Jose, California, 95124
Vanda Pharmaceuticals, (202) 734-3400
- Not yet recruiting
Vanda Investigational Site
Syosset, New York, 11791
Vanda Pharmaceuticals, (202) 734-3400
- Recruiting
Vanda Investigational Site
Tampa, Florida, 33613
Vanda Pharmaceuticals, (202) 734-3400
About this study
Official title: 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
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.
- Conditions
- Nausea and Vomiting, Obesity
- Being tested
- Tradipitant, Placebo
- Keywords
- GLP-1R agonist, Semaglutide, Nausea, Vomiting
- Medical subject headings
- Nausea, Vomiting, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TradipitantDrug
Also called Nereus, VLY-686
Oral Capsule
PlaceboDrug
Oral Capsule
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Treatment with placebo BID for approximately 2 weeks Receives: Drug: Placebo |
| Tradipitant Group | Experimental | Treatment with tradipitant BID for approximately 2 weeks Receives: Drug: Tradipitant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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.
Measured: 1 week
Secondary outcomes (2)
Proportion of participants with worst nausea severity score ≥ 3 and at least one vomiting episode over 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.
Measured: 1 week
To evaluate the effect of tradipitant relative to placebo on the worst of 7 daily nausea severity scores over 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).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start27 Mar 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vanda Pharmaceuticals Inc., Study director, Vanda Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446439
- Sponsor's protocol ID
- VP-VLY-686-3601
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07446439
- Acronym / sponsor ID
- VP-VLY-686-3601
- Conditions
- Nausea and Vomiting, Obesity
- Keywords
- GLP-1R agonist, Semaglutide, Nausea, Vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Drug: PlaceboTreatment with placebo BID for approximately 2 weeks |
| Tradipitant Group | Experimental | Drug: TradipitantTreatment with tradipitant BID for approximately 2 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body Mass Index ≥ 25 and < 40 kg/m^2
- No serious medical problems or chronic diseases, specifically no type I or type II diabetes
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TradipitantAlso: Nereus, VLY-686Oral Capsule | Drug | Tradipitant Group |
| PlaceboOral Capsule | Drug | Placebo Group |
Primary outcome
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
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.
2 secondary outcomes
Proportion of participants with worst nausea severity score ≥ 3 and at least one vomiting episode over 1 week.
Time frame: 1 week
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vanda Pharmaceuticals Inc. study director
Vanda Pharmaceuticals Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tradipitant in people with Nausea and Vomiting and Obesity, run by Vanda Pharmaceuticals at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanda Pharmaceuticals ((202) 734-3400, clinicaltrials@vandapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.