Health TrialsbyHealthPanel

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

ConditionsNausea and VomitingObesity
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVanda Pharmaceuticals

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Body Mass Index ≥ 25 and < 40 kg/m²

No serious medical problems or chronic diseases, specifically no type I or type II diabetes

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Tradipitant

    Drug

    Oral Capsule

  • Placebo

    Drug

    Oral Capsule

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: Placebo GroupPlacebo comparator 1 intervention
Group B: Tradipitant GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 week

Secondary outcomes

1

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.

Time frame
1 week
2

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).

Time frame
1 week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanda Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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