Study to Assess the Efficacy of VLY-686 in Relieving Symptoms of Gastroparesis

Study Overview
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Brief Summary
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This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States. One hundred fifty (150) subjects diagnosed with gastroparesis, who satisfy the selection criteria for the study, will be randomized to one of two treatment groups, active or placebo.

Detailed Description
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This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States. One hundred fifty (150) subjects diagnosed with gastroparesis, who satisfy the selection criteria for the study, will be randomized to one of two treatment groups, active or placebo. The study is divided into two phases: the screening phase and the evaluation phase. The screening phase includes a screening visit to evaluate subjects' preliminary eligibility for the study. During the screening phase, subjects will collect diary data for at least 4 weeks. The evaluation phase includes 4 weeks of randomized double-blind treatment.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Efficacy of VLY-686 (Tradipitant) in Relieving Symptoms of Gastroparesis

Conditions
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Gastroparesis

Intervention / Treatment
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* Drug: VLY-686 (Tradipitant)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with gastroparesis; Subjects must agree to the use of contraception Ability and acceptance to provide written informed consent; Willing to participate in the pharmacogenomics sample collection; Willing and able to comply with all study requirements and restrictions Willing to not participate in any other interventional trial for the duration of their participation. Exclusion Criteria: Another active disorder or treatment which could explain or contribute to symptoms in the opinion of the Investigator (including but not limited to gastric malignancy, neurological disorder, or heavy doses of strong anticholinergics); Pregnancy or nursing; History of intolerance and/or hypersensitivity to medications similar to VLY-686 (Tradipitant) and its accompanying excipients; Use of another NK1 antagonist or palonosetron; Exposure to any investigational medication, including placebo, within 60 days of the Baseline Visit; Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance, or may confound study results.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Drug<br>VLY-686 (Tradipitant) oral capsule for 4 weeks. | Drug: VLY-686 (Tradipitant)<br>* oral capsule<br>|
| Placebo Comparator: Placebo<br>Placebo oral capsule for 4 weeks. | Other: Placebo<br>* placebo oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gastroparesis associated symptoms as assessed by patient reported diary |  | 4 weeks |