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AuthorisedTherapeutic exploratory (Phase II)Interventional

J2R-MC-YAAD: A Phase 2, Double-blind, Placebo-Controlled Study to Evaluate LY3537021 for the Treatment of Chemotherapy-Induced Nausea and Vomiting in Adult Participants With Malignant Disease

This study, called J2R-MC-YAAD, is investigating a new medication, LY3537021 (which might also be called Lagipra), to see how well it can stop people from feeling sick and throwing up after they’ve had chemotherapy for cancer. Chemotherapy can be very effective against cancer, but it often causes unpleasant side effects like nausea and vomiting. The study is comparing this new drug with a dummy pill (placebo) and other widely used anti-sickness medicines such as granisetron, palonosetron, ondansetron, and aprepitant, sometimes given with dexamethasone. Doctors want to see if the new medicine helps people feel much better and avoid needing extra anti-sickness drugs in the days after their chemotherapy. This is a Phase 2 study, meaning it's still in the earlier stages of exploring how well and safely the treatment works.

At a glance

Status
Authorised
Phase
Therapeutic exploratory (Phase II)
Sponsor
Eli Lilly & Co.
Enrolment target
77
Start
23 Feb 2026

What is this study about?

When you have cancer treatment like chemotherapy, it can sometimes make you feel very sick and cause you to throw up. Doctors call this 'chemotherapy-induced nausea and vomiting' (CINV). It's one of the most common and difficult side effects people face, and it can really affect how you feel and your quality of life during treatment. While there are some medicines available to help with this, doctors are always looking for even better ways to prevent and manage these symptoms.

This study, named J2R-MC-YAAD, is a 'Phase 2' study. This means it's an important early step where researchers are carefully testing a new medication called LY3537021 (which you might also hear called Lagipra) to see how well it works to stop sickness and vomiting caused by chemotherapy. They want to find out if this new drug can help more people avoid these uncomfortable side effects compared to a dummy pill (placebo) or other commonly used anti-sickness medicines.

The main goal is to see how many people taking the new medicine have a 'complete response' in the days after their chemotherapy. A complete response means you don't throw up at all and don't need any extra anti-sickness medicine. By understanding how well this new drug works and if it's safe, researchers hope to improve the support given to people undergoing chemotherapy in the future.

Key takeaways

  • This study evaluates a new medicine (Lagipra) for chemotherapy-induced sickness.
  • It aims to find better ways to prevent nausea and vomiting during cancer treatment.
  • The study compares the new medicine to a dummy pill and existing treatments.
  • Participation involves taking medication, completing diaries, and regular check-ups.
  • You would be an adult receiving chemotherapy for cancer to be eligible.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 years or older, and already be undergoing treatment for cancer with chemotherapy. Both men and women can join.

The study team will discuss with you if this study is suitable, based on the type of cancer you have and the specific chemotherapy treatment you are receiving. They will check to make sure the study medication won't interfere with your current treatments or any other health conditions you might have.

It's important that you meet all the study requirements to ensure the safety of everyone involved and that the results of the study are clear and reliable. The study doctor will explain everything in detail.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Are you currently receiving chemotherapy for cancer?
  3. Are you able to attend regular study appointments?
  4. Are you willing to keep a daily record of how you feel?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given either the new medicine, LY3537021 (Lagipra), a dummy pill (placebo), or one of the standard anti-sickness medications. You wouldn't know which one you are taking, and neither would your study doctor – this is called a 'double-blind' study and helps make the results fair. You would take this medication around the time of your chemotherapy sessions.

Over a set period, you would need to keep track of how you are feeling, whether you've thrown up, and if you needed any extra anti-sickness medicine. This might involve filling out a short diary or answering questions from your study team. You'll have regular visits with the study doctor and nurses, where they will check your health, ask about any side effects, and take samples like blood tests. The total duration of your participation would depend on your chemotherapy schedule and the specific rules of the study, which the study team will explain fully.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving a new anti-sickness medicine that could work better for you, or getting extra monitoring from the study team. However, there are also potential risks, including side effects from the new medicine, or that it might not work as well as your current treatment. The study team will carefully explain all known risks before you decide to join, and you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Romania
  • Unverified
    Spain
  • Unverified
    France
  • Unverified
    Italy

Common questions

What is chemotherapy-induced nausea and vomiting (CINV)?

CINV stands for chemotherapy-induced nausea and vomiting. It's the feeling of sickness and throwing up that some people experience after having their cancer treatment.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the real medicine but contains no active drug. It helps researchers compare the new medicine fairly.

What does 'double-blind' mean?

Double-blind means that neither you nor your study doctor will know whether you are receiving the new medicine or the placebo. This helps ensure unbiased results.

Will I get extra medical care if I join this study?

While in the study, you'll have specific check-ups and monitoring related to the research, in addition to your usual medical care, which may mean you have more medical contact than usual.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time and for any reason, without needing to explain why, and it won't affect your regular medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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