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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group | Placebo Comparator | Treatment with placebo BID for approximately 2 weeks |
|
| Tradipitant Group | Experimental | Treatment with tradipitant BID for approximately 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tradipitant | Drug | Oral capsule |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week |
| Safety and tolerability of tradipitant after administration of semaglutide as measured by spontaneous reporting of adverse events (AEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vanda Pharmaceuticals | Vanda Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanda Investigational Site | Los Angeles | California | 90025 | United States | ||
| Vanda Investigational Site |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Drug |
Oral capsule |
|
Safety will be monitored using vital signs, blood chemistry, hematology, urology, and ECGs (QT, PR, QTcF, QTcB, QRS intervals and heart rate). |
| 2 weeks |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Vanda Investigational Site | New York | New York | 10016 | United States |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |