Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase IIb Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Combination Compared to Zibotentan Monotherapy as well as Zibotentan/Dapagliflozin and Zibotentan Monotherapy Compared to Placebo in Participants with Cirrhosis

This study is investigating new ways to help people living with cirrhosis, a condition where the liver is scarred and damaged. Researchers are testing two different treatments: a combination of two medications called Zibotentan and Dapagliflozin, and Zibotentan on its own. They want to find out how safe these treatments are and if they can help manage problems like fluid retention, which can be common with cirrhosis. The study will compare these medications to a 'placebo', which is a dummy pill with no active drug, to see if the real treatments are effective. Participants' body weight, water levels, and reactions to the medications will be carefully monitored over six weeks. This study is in an early stage (Phase IIb), focusing on safety and how well the treatment is tolerated.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Astrazeneca AB

Enrolment target

Start

02 Apr 2024

Cirrhosis of the liver is a condition in which the liver is scarred and damaged

What is this study about?

If you have cirrhosis, which means your liver is scarred and not working as well as it should, you might experience issues like fluid building up in your body. This research study is looking for better ways to manage these sorts of problems. The study is particularly interested in two medications: one called Zibotentan and another called Dapagliflozin.

The main goal of this study is to check how safe these medications are, both when Zibotentan is given alone and when it's combined with Dapagliflozin. Researchers will also compare these treatments to a 'placebo', which looks like the real medicine but doesn't contain any active ingredients. This helps them understand whether any changes are due to the medication itself or other factors.

Over a six-week period, the study will carefully monitor several things to see how participants respond to the treatments. This includes changes in body weight, the amount of water in the body, and how much diuretic medication (water tablets) people might need. They will also keep a close eye on any side effects to make sure the treatments are well tolerated.

Key takeaways

This study is for people with scarred livers (cirrhosis).
It tests new medications for safety and fluid retention.
You might receive Zibotentan alone, with Dapagliflozin, or a dummy pill.
The study lasts at least six weeks with regular checks.
It's a 'blinded' study, so you won't know which treatment you receive.

Who may be eligible?

To join this study, you must be at least 18 years old. The study is open to both men and women.

The most important condition for taking part is that you have cirrhosis, which is scarring and damage to your liver.

There might be other health conditions or medications that would prevent you from joining, as the researchers need to ensure it's safe for everyone involved. A doctor will check all of these details to see if this study is right for you.

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 18 years old or older?
Have you been diagnosed with cirrhosis (scarring of the liver)?
Are you able to attend regular appointments for monitoring?
Are you open to potentially receiving a dummy pill (placebo) or one of the study drugs?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either one of the study medications (Zibotentan on its own or Zibotentan combined with Dapagliflozin) or a placebo (a dummy pill). Neither you nor your study doctor will know which treatment you are receiving until the study ends. Throughout the study, you'll have regular visits where researchers will check your body weight, measure fluid levels in your body, and monitor your blood pressure. You'll also have blood tests and ECGs (heart tracings) to check your health. Some monitoring of your weight might be done at home. The main part of the study where these measurements are focused will last for six weeks.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that you might receive a treatment that helps manage your fluid retention or other symptoms related to cirrhosis. You will also receive very close medical monitoring throughout the study. However, there's always a risk of experiencing side effects from the study medications, or that the treatment may not help you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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

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Unverified
Belgium
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Unverified
Slovakia
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Unverified
Czechia
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Unverified
Germany
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Unverified
Italy
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Unverified
Poland

Common questions

What is cirrhosis?

Cirrhosis is when your liver becomes scarred and damaged, making it harder for it to work properly.

What does 'placebo-controlled' mean?

It means some people will get the active medicine, and some will get a dummy pill with no medicine, to see how effective the real treatment is.

What is the study hoping to find out?

The study wants to see how safe the new medications are and if they can help people with cirrhosis manage fluid build-up in their bodies.

How long will I be in the study?

The main part of the study where changes are closely measured focuses on a six-week period.

Will I know which treatment I'm getting?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know if you're getting the medicine or the placebo.