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Safety Study of Tradipitant for Patients with Idiopathic or Diabetic Gastroparesis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as gastroparesis, which affects the stomach's ability to empty food properly. The study specifically looks at two types of gastroparesis: idiopathic gastroparesis, where the cause is unknown, and diabetic gastroparesis, which occurs in people with diabetes. Patients involved in this study experience moderate to severe nausea as a symptom of their gastroparesis. The treatment being tested is a medication called tradipitant, also known by its code name VLY-686. This medication is taken in the form of a capsule.

The purpose of the study is to evaluate the safety of using tradipitant in patients with gastroparesis. Participants will take the medication over a period of three months. During this time, researchers will monitor the patients for any side effects or changes in their health. This includes checking for any adverse events, such as changes in mood or behavior, as well as monitoring vital signs, laboratory test results, heart function through electrocardiograms (ECGs), and physical health assessments.

The study is designed to ensure that the medication is safe for patients to use. Participants will be asked to keep a daily diary of their symptoms and follow certain guidelines, such as avoiding other medications that could interfere with the study. The trial aims to provide valuable information on how tradipitant can be used to help manage symptoms of gastroparesis safely.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, you will attend an initial visit. During this visit, you will provide written consent to participate in the trial. This is a formal agreement indicating your willingness to be part of the study.

    You will undergo a series of assessments to confirm your eligibility. These assessments include reviewing your medical history, current symptoms, and any previous tests related to your condition, idiopathic or diabetic gastroparesis with moderate to severe nausea.

  2. Step 2

    Medication administration

    You will begin taking the study medication, tradipitant, which is provided in capsule form. The medication is taken orally.

    The dosage and frequency of the medication will be explained to you by the study team. You will take the medication as directed for a duration of three months.

  3. Step 3

    Daily symptom diary

    Throughout the study, you will be required to maintain a daily symptom diary. This involves recording your symptoms, such as nausea, vomiting, and any other related experiences.

    The diary helps track the effectiveness of the medication and any changes in your condition over time.

  4. Step 4

    Regular check-ups

    You will attend regular check-up visits with the study team. These visits are scheduled to monitor your health and the effects of the medication.

    During these visits, various assessments will be conducted, including checking vital signs, laboratory tests, and possibly electrocardiograms (ECGs) to ensure your safety.

  5. Step 5

    Final evaluation

    At the end of the three-month period, you will have a final evaluation. This will involve a comprehensive review of your health and any changes in your symptoms.

    The study team will discuss the results with you and provide any necessary follow-up instructions.

Who can join the trial?

11 criteria

  • Participants must be male or female and aged between 18 and 70 years old.
  • Must have been diagnosed with idiopathic or diabetic gastroparesis and experience moderate to severe nausea.
  • Must have shown delayed stomach emptying of a solid meal in the past 10 years, confirmed by specific medical tests. If a solid meal is not tolerated, a liquid meal test may be used.
  • Must have had nausea symptoms for at least 6 months before the study.
  • Symptoms of gastroparesis must continue despite changes in diet or lifestyle.
  • Must have a Body Mass Index (BMI) between 18 and 40 kg/m². BMI is a measure of body fat based on height and weight.
  • Participants must agree to use contraception if they are capable of having children. This applies to both males and females.
  • Must be able to provide written consent to participate in the study.
  • Must be willing to participate in the collection of genetic samples for research purposes.
  • Must be willing and able to follow all study requirements, including keeping a daily symptom diary, avoiding certain medications, and managing blood sugar levels if they have diabetes.
  • Must agree not to participate in any other interventional trials while taking part in this study.

Who cannot join the trial?

3 criteria

  • Patients with **idiopathic** or **diabetic gastroparesis** who do not experience moderate to severe nausea cannot participate. Idiopathic means the cause is unknown, and gastroparesis is a condition where the stomach cannot empty food properly.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, which may include groups like children, pregnant women, or those unable to consent, cannot participate.
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Investigated drugs

Tradipitant is a medication being studied for its safety in patients with a condition called gastroparesis, which affects how the stomach empties food. This medication is being tested to see if it can help manage symptoms in people with gastroparesis, whether it is caused by diabetes or has no known cause. The study aims to ensure that taking tradipitant is safe for patients over a period of three months.

What is already known about the treatment

Tradipitant – Tradipitant is administered orally in the form of a tablet and is currently being studied in clinical trials for its safety in treating idiopathic or diabetic gastroparesis, which is a condition characterized by delayed stomach emptying and moderate to severe nausea. In medical literature, it is being evaluated for its potential benefits in managing symptoms associated with this condition. The main therapeutic indication for Tradipitant is to alleviate nausea in patients with gastroparesis. At the molecular level, Tradipitant works by blocking a specific receptor in the brain called the neurokinin-1 (NK1) receptor, which is involved in the vomiting reflex. It is classified pharmacologically as a neurokinin-1 receptor antagonist.

Investigated diseases

  • Idiopathic Gastroparesis

    Idiopathic gastroparesis is a condition characterized by delayed gastric emptying without an identifiable cause. It leads to symptoms such as nausea, vomiting, bloating, and abdominal pain. The stomach muscles or nerves do not function properly, causing food to move slowly or stop moving through the digestive tract. This can result in nutritional deficiencies and dehydration due to poor absorption of nutrients. The severity of symptoms can vary, and they may worsen over time. Management focuses on dietary changes and symptom relief.

  • Diabetic Gastroparesis

    Diabetic gastroparesis is a disorder that affects the stomach muscles and is a complication of diabetes. It occurs when high blood sugar levels damage the vagus nerve, which controls the movement of food through the digestive tract. This results in delayed gastric emptying, leading to symptoms like nausea, vomiting, bloating, and feeling full quickly. The condition can cause fluctuations in blood sugar levels, making diabetes management more challenging. Symptoms can be persistent and may interfere with daily activities. Dietary adjustments and monitoring of blood glucose levels are important in managing the condition.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503802-35-00Protocol codeVP-VLY-686-3304Estimated enrolment70 patientsSponsorVanda Pharmaceuticals Inc.

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