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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.
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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 |
|
|
| 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 questionnaire called the Nausea Vomiting Daily Diary (NV-DD) will be completed once a day, which will be used to collect data for this endpoint. The NV-DD asks participants to record their vomiting frequency in a 24-hour period. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with worst nausea severity score ≥ 3 and at least one vomiting episode over 1 week. | 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 their vomiting frequency in a 24-hour period. | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vanda Pharmaceuticals | Contact | (202) 734-3400 | clinicaltrials@vandapharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Vanda Pharmaceuticals Inc. | Vanda Pharmaceuticals Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanda Investigational Site | Recruiting | Los Angeles | California | 90025 | United States |
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| Placebo | Drug | Oral Capsule |
|
| To evaluate the effect of tradipitant relative to placebo on the worst of 7 daily nausea severity scores over 1 week. | Nausea 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). | 1 week |
| Vanda Investigational Site | Recruiting | San Diego | California | 92108 | United States |
|
| Vanda Investigational Site | Not yet recruiting | San Jose | California | 95124 | United States |
|
| Vanda Investigational Site | Recruiting | Tampa | Florida | 33613 | United States |
|
| Vanda Investigational Site | Not yet recruiting | Hamilton | New Jersey | 08690 | United States |
|
| Vanda Investigational Site | Not yet recruiting | New York | New York | 10016 | United States |
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| Vanda Investigational Site | Not yet recruiting | Syosset | New York | 11791 | United States |
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| Vanda Investigational Site | Not yet recruiting | Plano | Texas | 75024 | United States |
|
| Vanda Investigational Site | Not yet recruiting | San Antonio | Texas | 78215 | United States |
|
| Vanda Investigational Site | Not yet recruiting | Burke | Virginia | 22015 | United States |
|
| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C527551 | LY686017 |
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