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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
124
Oral capsule
Oral capsule
Vanda Investigational Site
Los Angeles, California, United States
Vanda Investigational Site
Rochester, Minnesota, United States
Vanda Investigational Site
New York, New York, United States
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 daily diary called the Nausea Vomiting Daily Diary (NV-DD) will be used. 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 record the duration of nausea and vomiting frequency.
Time frame: 1 week
Individual gastrointestinal symptoms
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 record the duration of nausea and vomiting frequency.
Time frame: 1 week
Safety and tolerability of tradipitant after administration of semaglutide as measured by spontaneous reporting of adverse events (AEs)
Safety will be monitored using vital signs, blood chemistry, hematology, urology, and ECGs (QT, PR, QTcF, QTcB, QRS intervals and heart rate).
Time frame: 2 weeks
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