A Study to Measure the Effects of Using Tradipitant on Nausea and Vomiting After GLP-1R Agonist Use

Vanda Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Drug: Placebo; Drug: Tradipitant

Study type: Interventional

Funder types: Industry

Identifiers

NCT06804603

VP-VLY-686-2601

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body Mass Index 25-40 kg/m^2 inclusive
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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124 participants in 2 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

Treatment with placebo BID for approximately 2 weeks

Treatment:

Drug: Placebo

Tradipitant Group

Experimental group

Description:

Treatment with tradipitant BID for approximately 2 weeks

Treatment:

Drug: Tradipitant