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Actively Recruiting

Phase 3
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID07446439

The Thetis Study Evaluating Tradipitant Capsules to Treat Nausea and Vomiting Caused by GLP-1R Agonists in Overweight and Obese Adults

Led by Vanda Pharmaceuticals · Updated on 2026-04-20

280

Participants Needed

10

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of Tradipitant on treating nausea and vomiting caused by GLP-1 receptor agonist use in adults who are overweight or have class I or II obesity. This phase 3, randomized, placebo-controlled study includes healthy volunteers without serious medical issues or diabetes. The goal is to better understand how Tradipitant impacts these symptoms compared to a placebo. Participants will be randomly assigned to receive either Tradipitant or a placebo, both given as oral capsules twice daily for about two weeks. The study has two treatment arms one receiving Tradipitant and the other receiving a placebo. The study uses quadruple masking to ensure unbiased results. During the study, participants will record nausea and vomiting symptoms daily in a symptom diary. Researchers will measure the proportion of participants experiencing vomiting episodes and assess nausea severity over one week. The study will monitor safety and side effects throughout, with the total participation duration around two weeks of treatment.

CONDITIONS

Brief Title

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

Research Team

V

Vanda Pharmaceuticals

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