Clinical trial

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

Recruiting now · Phase 3 · 1 countries · Registry ID NCT07446439

Recruiting nowPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersAccepted

ConditionNausea and Vomiting, Obesity

Full registry criteria

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

Treatments and study arms

Tradipitant

Drug

Oral Capsule

Placebo

Drug

Oral Capsule

Primary outcomes

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.