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A Study to Evaluate LY3537021 and a Drug Combination for Treating Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer

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What is this trial about?

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

This study is being conducted to evaluate the effectiveness of a drug named LY3537021 in treating nausea and vomiting that occurs as a result of chemotherapy. These symptoms are common side effects in adults diagnosed with cancer, which is a broad term for neoplasms, or abnormal growths of cells in the body. The study aims to compare how well this new medication works when added to other existing treatments compared to a placebo.

The medications used during the study include several types of antiemetic drugs, which are substances used to prevent or reduce vomiting and nausea. These medications include ondansetron, aprepitant, palonosetron, granisetron, and dexamethasone. Some of these medicines are taken by mouth, while others may be given through an intravenous line, which is a small tube inserted into a vein to deliver medicine directly into the bloodstream, or via subcutaneous injection, which means the medicine is injected just under the skin.

During the course of the study, participants will be assigned to different groups to receive either the new medication or a placebo alongside their current anti-nausea treatments. The different groups will be monitored to see how many people experience a complete response, meaning they have no vomiting and do not need to take extra rescue medicine to manage their symptoms.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Medication administration

    The treatment involves receiving ly3537021, which is administered via subcutaneous use (an injection under the skin).

    This medication is used alongside other antiemetic treatments, which are medicines used to prevent nausea (the feeling of needing to vomit) and vomiting (the act of ejecting stomach contents).

  2. Step 2

    Combination therapies

    Other medications may be administered as part of the treatment process, including aprepitant (285 mg) and ondansetron (24 mg) via oral use (swallowing by mouth).

    Additional treatments may include palonosetron combinations (300 mg) taken orally, granisetron (2 mg) taken orally, or dexamethasone (12 mg) taken orally.

    palonosetron (0.5 mg) may also be administered via intravenous use (delivered directly into a vein).

    A placebo, which is an inactive substance such as 0.9% sodium chloride, may be used instead of the active study medication to allow for comparison.

Who can join the trial?

4 criteria

  • You must be receiving a type of cancer treatment that includes cisplatin (a chemotherapy drug used to kill cancer cells) or a combination of anthracycline (a group of drugs used to treat cancer) and cyclophosphamide (another type of medicine used to treat cancer).
  • You must be physically able to walk and perform light daily activities.
  • You can be either female or male.
  • You must be at least 3 years old.

Who cannot join the trial?

7 criteria

  • You have previously received chemotherapy, which is a type of medical treatment that uses strong medicines to kill cancer cells.
  • You are scheduled to receive chemotherapy between the second and fifth day of each treatment cycle.
  • You have neoplasms, which are abnormal growths of tissue like tumors, that have spread to your brain or spinal cord and are causing symptoms or have not been treated.
  • You have uncontrolled diabetes, a condition where blood sugar levels are too high and not properly managed, or you have serious heart problems or issues with your heart rhythm, which is the pattern of your heartbeat.
  • Your nausea (feeling like you might vomit) or vomiting (the act of actually throwing up) is caused by something other than the treatment being studied, or you are already taking medicines to prevent or treat these issues.
  • You have signs, symptoms, or a history of thyroid tumors, which are growths located in the thyroid gland in your neck.
  • You have taken medicines called incretins, which are a specific type of medication that affects how your body manages sugar, within 4 weeks before starting chemotherapy.
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Investigated drugs

  • Ondansetron

    is a medication taken by mouth that helps to prevent nausea and vomiting.

  • Aprepitant

    is a medication taken by mouth used to prevent nausea and vomiting.

  • Palonosetron

    is a medication used to prevent nausea and vomiting, which can be taken by mouth or through an IV injection.

  • Lagipra

    is an experimental medication given as an injection under the skin to help prevent nausea and vomiting.

  • Granisetron

    is a medication taken by mouth to help control nausea and vomiting.

  • Dexamethasone

    is a medication taken by mouth used to help prevent nausea and vomiting.

What is already known about the treatment

  • Ondansetron

    This medication is taken orally and is widely used in medicine to prevent nausea and vomiting. It belongs to a group of drugs called serotonin receptor antagonists. It works by blocking a specific chemical messenger in the body that triggers the urge to vomit.

  • Aprepitant

    This drug is administered orally and is a well-established treatment for preventing nausea caused by chemotherapy. It is classified as a neurokinin-1 receptor antagonist. At the molecular level, it works by blocking a substance in the brain called substance P, which is responsible for sending vomiting signals to the brain.

  • Palonosetron

    This medication can be taken as an oral pill or administered through an intravenous injection to manage nausea and vomiting. It is a second-generation serotonin receptor antagonist commonly used in clinical practice. It works by binding strongly to specific receptors in the digestive tract and brain to stop the signals that cause vomiting.

  • LY3537021

    This substance is administered via a subcutaneous injection, which means it is placed just under the skin. It is currently being studied in clinical trials as a potential new treatment for nausea and vomiting related to cancer. It is designed to target specific pathways in the nervous system to prevent the sensation of sickness.

  • Granisetron

    This medication is taken orally and is a standard treatment used to control nausea and vomiting. It is classified as a serotonin receptor antagonist. The drug works by preventing serotonin from attaching to receptors in the gut and brain that trigger the vomiting reflex.

  • Dexamethasone

    This medication is taken orally and is a widely used steroid used to reduce inflammation and prevent nausea. It belongs to a class of drugs known as corticosteroids. It works by lowering the body's immune response and reducing swelling or irritation that can contribute to feeling sick.

Investigated diseases

  • Nausea

    This is a sensation of unease and discomfort in the upper stomach, often accompanied by an urge to vomit. It can occur suddenly and may be triggered by various internal or external factors. The feeling can range from mild discomfort to intense sickness.

  • Drug-Related Side Effects and Adverse Reactions

    These are unwanted or harmful responses that occur when a person takes a medication. They can range from mild symptoms to more significant bodily changes. These reactions typically appear after the administration of a substance and can affect different organ systems.

  • Vomiting

    This is the forceful expulsion of the contents of the stomach through the mouth. It is often a physical response to various stimuli affecting the digestive system or the brain. The process can occur in single episodes or multiple times in a short period.

  • Neoplasms

    These are abnormal growths of cells within the body. The cells multiply more rapidly than normal and may form masses known as tumors. These growths can be localized or spread to other parts of the body over time.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522204-24-00Protocol codeJ2R-MC-YAADEstimated enrolment205 patientsSponsorEli Lilly & Co.

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