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AuthorisedTherapeutic exploratory (Phase II)Interventional

TREAT-EC (Tirzepatide in the treatment of endometrial cancer) - a clinical trial

The TREAT-EC study (Tirzepatide in the treatment of endometrial cancer) is a clinical trial exploring new ways to treat a specific type of womb cancer called endometrial cancer. We are investigating whether a new medication called Mounjaro, either on its own or alongside a Mirena coil, can help make the cancer disappear. Researchers will be looking at what percentage of patients show no signs of cancer after 12 months of treatment. We will also be checking if these treatments help with weight loss, how they affect cell changes in the womb, and how they impact patients' quality of life. Understanding these factors will help us learn more about potential new treatment options for this condition.

At a glance

Status
Authorised
Phase
Therapeutic exploratory (Phase II)
Sponsor
University College Dublin
Enrolment target
78
Start
02 Apr 2026

What is this study about?

This study, called TREAT-EC, is looking into how a new medicine, Tirzepatide (also known as Mounjaro), might help treat a type of womb cancer. Womb cancer is when abnormal cells grow in the lining of the womb. The study is particularly focused on 'endometrial adenocarcinoma', which is the most common type of womb cancer.

Researchers are using Mounjaro in combination with a Mirena coil in some patients, and Mounjaro on its own in others. The main goal is to see if these treatments can make the cancer go away, which doctors call a 'complete response' (pCR). They will check this after 12 months using a small tissue sample from the womb. If the cancer cells are gone, it's a very positive sign.

Beyond treating the cancer, the study will also look at other important things. For example, Mounjaro is known to help with weight loss, so researchers will track if patients lose weight. They will also look at how the treatment affects cell changes in the womb, and importantly, how it impacts a person's general well-being and quality of life. This trial is in an early stage (Phase II), meaning it's exploring whether these treatments work and are safe.

Key takeaways

  • This study is testing Mounjaro, with or without a Mirena coil, for womb cancer.
  • The main goal is to see if the cancer can be made to disappear completely.
  • Researchers will also look at weight loss and quality of life.
  • It involves regular visits and womb biopsies over 12 months.
  • You must be a woman, aged 18 or over, with endometrial adenocarcinoma.

Who may be eligible?

This study is for women aged 18 and over. Participants will have been diagnosed with a specific type of womb cancer called endometrial adenocarcinoma.

To be considered for this study, your doctors will need to check your medical history and current health carefully to make sure the treatment is suitable for you. There might be other specific health requirements or conditions that mean you can or cannot join the study, which your doctor will discuss.

It's important to have an open conversation with your healthcare team to understand whether this study is the right option for you, based on your individual health situation.

Quick self-check
  • Are you 18 years old or older?
  • Are you female?
  • Have you been diagnosed with endometrial adenocarcinoma (a type of womb cancer)?
  • Are you able to attend regular hospital appointments for 12 months?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you would be taking either Mounjaro medication, or Mounjaro alongside a Mirena coil, for 12 months. Mounjaro is given as an injection using a special pen. The dose may vary, starting from 2.5 mg and potentially increasing up to 15 mg.

Throughout the 12 months, you would have regular hospital visits – usually around 14 visits in total. These visits will involve various checks, including samples from your womb lining (biopsies) to see how the cancer is responding. We will also measure your weight, take blood tests, and ask you to complete questionnaires about your quality of life at different points during the study. After the 12 months of treatment, there will be continued monitoring to track your health progress.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new treatment that could help with your womb cancer and potentially with weight loss. However, these treatments may also have side effects, which your doctor will explain in detail. There is always a chance that the treatment may not work for everyone. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

  • Ireland

Common questions

What is endometrial cancer?

Endometrial cancer is a type of cancer that starts in the lining of your womb (uterus). This study focuses on the most common type, called endometrial adenocarcinoma.

What is Mounjaro?

Mounjaro is the brand name for a new medicine called tirzepatide. It's often used to help manage blood sugar in people with diabetes and can also lead to weight loss.

What is a Mirena coil?

A Mirena coil is a small device inserted into the womb that slowly releases a hormone. It's often used for contraception or to treat heavy periods, but sometimes also in certain gynaecological conditions.

What does 'pCR' mean?

pCR stands for 'pathological complete response'. In this study, it means that after treatment, there are no signs of cancer cells or severe cell changes in a tissue sample taken from the womb.

How long will I be in the study?

The treatment part of the study lasts for 12 months (about a year). You will have regular check-ups during this time and likely some follow-up after your treatment finishes.

How to find out more

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

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