Recruiting
Phase 3

Tradipitant

Sponsor:

Vanda Pharmaceuticals

Code:

NCT07446439

Conditions

Nausea and Vomiting

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Tradipitant

Placebo

Study Details

Brief 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.

Conditions

Nausea and Vomiting

Obesity

Study ID

NCT07446439

Start date

Mar 27, 2026

Status verified date

Feb, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

280 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo Group

Treatment with placebo BID for approximately 2 weeks

experimental: Tradipitant Group

Treatment with tradipitant BID for approximately 2 weeks

Interventions

Tradipitant

Oral Capsule

Placebo

Oral Capsule

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 ]

Central Contacts and Locations

Central contacts

Vanda Pharmaceuticals

(202) 734-3400clinicaltrials@vandapharma.com

Locations

Vanda Investigational Site

Recruiting

Los Angeles, California, United States, 90025

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

San Diego, California, United States, 92108

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Tampa, Florida, United States, 33613

Contacts

Vanda Pharmaceuticals

(202) 734-3400

More Information

Sponsor

Vanda Pharmaceuticals

Last update posted

Apr 20, 2026

Last verified

Feb, 2026

Keywords

  • GLP-1R agonist
  • Semaglutide
  • Nausea
  • Vomiting

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vanda Pharmaceuticals on 2026-04-20.