Not yet recruitingPHASE2INTERVENTIONAL

Maralixibat for Intrahepatic Cholestasis of Pregnancy

This research study is called an 'open-label Phase 2a/b trial' and it's looking into a new medicine called Maralixibat. The study is for pregnant individuals who have a liver condition called Intrahepatic Cholestasis of Pregnancy (ICP). ICP can cause severe itching and is linked to high levels of bile acids in the blood. The main aim of this study is to check how safe Maralixibat is and how well people tolerate it. Knowing whether a medicine is safe and tolerable is a very important first step in understanding if it could be a helpful treatment for ICP in the future. Participants will be closely monitored throughout the study.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Imperial College London

Enrolment target

Start

01 Apr 2026

Estimated completion

31 Mar 2028

Intrahepatic Cholestasis of Pregnancy

What is this study about?

This study is specifically designed for pregnant people who have a condition called Intrahepatic Cholestasis of Pregnancy, often shortened to ICP. ICP is a liver condition that only happens during pregnancy. It can cause uncomfortable symptoms like severe itching and, importantly, it's linked to higher levels of bile acids in your blood. These high bile acid levels need to be managed carefully.

The medicine being tested in this study is called Maralixibat. At the moment, our understanding of how this medicine works for ICP is still developing. This study, known as a Phase 2 trial, is a crucial step in this process. It's focused on finding out whether Maralixibat is safe for pregnant people and their babies, and how well people cope with taking the medicine. It's a vital stage to make sure any potential new treatment is gentle and doesn't cause too many side effects.

By taking part, you would be helping researchers learn more about ICP and whether Maralixibat could be a useful way to manage the condition. This goes a long way in potentially offering new and better treatment options for other pregnant individuals with ICP in the future. Your involvement could make a real difference to future care.

Key takeaways

This study is testing a new medicine, Maralixibat, for Intrahepatic Cholestasis of Pregnancy (ICP).
It aims to find out if the medicine is safe and how well pregnant people tolerate it.
Participants must have ICP and elevated bile acid levels.
Close medical monitoring is provided throughout the study.
Your involvement could help future patients with ICP.
You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you need to be a woman between 18 and 50 years old and be pregnant with one baby. Your pregnancy should be between 20 and 34 weeks when you first join the study, and no more than 35 weeks at the official start day. You must have been diagnosed with ICP and have higher-than-normal levels of bile acids in your blood, as shown by a recent blood test.

There are also some reasons why you might not be able to join. For example, if there's already a plan for your baby to be born within the next 7 days, you wouldn't be able to take part. Also, if there are any known concerns about your baby's health or if tests show your baby isn't doing well, the study wouldn't be right for you. You also can't be taking part in another medicinal research study at the same time.

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.

Are you female, aged between 18 and 50?
Are you pregnant with one baby, between 20 and 34 weeks currently?
Have you been diagnosed with ICP?
Are your bile acid levels elevated (≥19 μmol/L) on a blood test?
Are you willing to attend all study appointments and follow-up?
Are you NOT currently in another medicine study or due to deliver within 7 days?

Answer every question to see your result.

What does participation involve?

If you choose to take part in this study, you'll first need to read and sign a consent form, which means you agree to all the study rules. You'll have several visits to the clinic throughout your pregnancy. At these visits, doctors will check your health, take blood tests to measure your bile acid levels, and monitor your baby's health.

You would be given the study medicine, Maralixibat, to take regularly. The doctors and nurses will explain exactly how to take it. After your baby is born, there will be a follow-up period where your health and your baby's health will continue to be monitored to see if there are any long-term effects. The total duration of your involvement, from the start of the study until the final follow-up, will be explained in detail.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A possible benefit is that Maralixibat might help manage your ICP symptoms and reduce your bile acid levels. You'll also receive close medical care and monitoring throughout your pregnancy. However, like all medicines, Maralixibat might have side effects, which the study doctors will explain to you in detail. There might also be risks associated with the extra tests and procedures involved. It's very important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Birmingham Womens and Childrens NHS Foundation Trust
Verified postcode
Birmingham, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
Verified postcode
London, United Kingdom

Common questions

What is Intrahepatic Cholestasis of Pregnancy (ICP)?

ICP is a liver condition that can happen during pregnancy, causing intense itching and can lead to higher levels of bile acids in your blood.

What is Maralixibat?

Maralixibat is the medicine being tested in this study to see if it's safe and helps with ICP during pregnancy.

What does 'Phase 2' mean for a study?

Phase 2 means this study is an early step in testing a new medicine. It mainly focuses on seeing if the medicine is safe and if people can tolerate it well.

Will I know if I'm getting the medicine or a placebo?

This is an 'open-label' study, which means both you and the study team will know you are receiving Maralixibat. There is no placebo group in this specific trial.

How long will I be in the study?

The study involves continuing treatments and regular check-ups during your pregnancy, with a follow-up period after your baby is born. The exact length will be discussed with you.

How to find out more

Jenny Chambers

jenny.chambers@imperial.ac.uk 07843 660349 Official trial record

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