ObesityPhase 2NCT06804603
A Study to Measure the Effects of Using Tradipitant on Nausea and Vomiting After GLP-1R Agonist Use
A Phase 2 study testing Tradipitant in people with Obesity, run by Vanda Pharmaceuticals at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- 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
- 124 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Feb 2025to 6 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index 25-40 kg/m^2 inclusive
- 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
3 sites in 1 country.
United States3 sites
Vanda Investigational Site
Los Angeles, California, 90025
Vanda Investigational Site
New York, New York, 10016
Vanda Investigational Site
Rochester, Minnesota, 55905
About this study
Official title: 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
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.
- Conditions
- Obesity
- Being tested
- Tradipitant, Placebo
- Keywords
- GLP-1R agonist, semaglutide, obesity, nausea, vomiting
- Medical subject headings
- Obesity, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TradipitantDrug
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 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.
Measured: 1 week
Secondary outcomes (2)
Individual gastrointestinal symptoms
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 record the duration of nausea and vomiting frequency.
Measured: 1 week
Safety and tolerability of tradipitant after administration of semaglutide as measured by spontaneous reporting of adverse events (AEs)
Safety will be monitored using vital signs, blood chemistry, hematology, urology, and ECGs (QT, PR, QTcF, QTcB, QRS intervals and heart rate).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start25 Feb 2025
- Primary completion6 Oct 2025
- Study completion6 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vanda Pharmaceuticals, Study director, Vanda Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804603
- Sponsor's protocol ID
- VP-VLY-686-2601
- Status last verified
- Nov 2025
- First submitted
- 9 Jan 2025
- Last updated
- 12 Nov 2025
- 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 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06804603
- Acronym / sponsor ID
- VP-VLY-686-2601
- Conditions
- Obesity
- Keywords
- GLP-1R agonist, semaglutide, obesity, nausea, vomiting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 3 Feb 2025 (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 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.
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
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body Mass Index 25-40 kg/m^2 inclusive
- 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 |
|---|---|---|
| TradipitantOral 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 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.
2 secondary outcomes
Individual gastrointestinal symptoms
Time frame: 1 week
Safety and tolerability of tradipitant after administration of semaglutide as measured by spontaneous reporting of adverse events (AEs)
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- 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. This study is not recruiting at the moment.
Vanda Pharmaceuticals study director
Vanda Pharmaceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tradipitant in people with Obesity, run by Vanda Pharmaceuticals at 3 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: finished, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 12 Nov 2025.