Study on the Safety of Zibotentan and Dapagliflozin for Patients with Liver Cirrhosis

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What is this study about?

This clinical trial is focused on studying cirrhosis, a condition where the liver becomes scarred and damaged. The study will evaluate the safety of two medications, Zibotentan and Dapagliflozin, both individually and in combination. Zibotentan is taken as a hard capsule, while Dapagliflozin is a film-coated tablet. The trial will also include a comparison with a placebo. The purpose of the study is to understand how these treatments affect fluid retention, body weight, and blood pressure in people with cirrhosis.

Participants in the study will receive either the combination of Zibotentan and Dapagliflozin, Zibotentan alone, or a placebo. The study will last for a period of six weeks, during which the effects of the treatments on body weight, body water volumes, and blood pressure will be monitored. The trial aims to see if the combination of medications can better manage symptoms compared to taking Zibotentan alone or a placebo.

Throughout the study, participants will be closely monitored for any changes in their condition, including any side effects or adverse events. The trial will help determine the safety and effectiveness of using Zibotentan and Dapagliflozin together for treating cirrhosis. This research could provide valuable insights into new treatment options for managing this liver condition.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s objectives and procedures. The participant will provide informed consent, confirming understanding and agreement to participate in the study.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes a review of medical history and current health status, focusing on liver condition and any previous treatments.

3 randomization

Participants will be randomly assigned to one of the study groups. This could involve receiving either the combination of zibotentan and dapagliflozin, zibotentan alone, or a placebo.

4 medication administration

Participants will take the assigned medication orally. The specific dosage and frequency will be determined by the study protocol and communicated to the participant.

5 monitoring and follow-up

Regular monitoring will occur throughout the study. This includes checking body weight, body water volumes, and blood pressure. Participants will also report any side effects or changes in health.

6 end of study evaluation

At the end of the study period, a final evaluation will be conducted. This will assess the overall health of the participant and the effects of the medication.

Who Can Join the Study?

  • Participants must be between 18 and 80 years old.
  • Participants can be male or female, but females must not be able to have children. This means they must be post-menopausal (no periods for at least 12 months) or have had certain surgeries that prevent pregnancy.
  • Female participants must have a negative pregnancy test and must not be breastfeeding.
  • Participants must be able to understand and sign a consent form, agreeing to follow the study’s rules and procedures.
  • Participants must have a diagnosis of cirrhosis of the liver, which means the liver is scarred and damaged. They should have certain signs like varices (swollen veins) or specific liver stiffness measurements.
  • Participants must have a Model for End-Stage Liver Disease (MELD) score of less than 15. This score helps to assess the severity of liver disease.
  • Participants must have a Child-Pugh score of less than 10. This score is used to measure liver function.
  • Participants should have no or mild fluid buildup in the abdomen (ascites) and should not have needed a procedure to remove this fluid in the last month.
  • Participants should not have any worsening of liver function in the last month, as determined by a doctor.
  • Participants should not be currently using or have used certain medications like SGLT2 inhibitors or endothelin receptor antagonists in the past month.
  • Participants should be on a stable dose of beta blockers (a type of heart medication) with no major changes in the last month.
  • Male participants must be surgically sterile, abstinent, or use effective birth control methods with their partners to prevent pregnancy during the study and for 3 months after. They should also use condoms and not donate sperm during this time.

Who Cannot Join the Study?

  • Patients with cirrhosis of the liver, which means the liver is scarred and damaged, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Medizinische Hochschule Hannover Hanover Germany

Other Sites

Site Name City Country Status
Fakultna Nemocnica Trnava Trnava Slovakia
Promed P.Lach R.Glowacki Sp. j. Cracow Poland
Eugastro GmbH Leipzig Germany
Planetmed Sp. z o.o. Wroclaw Poland
Azienda Ospedaliera di Padova Padua Italy
Fakultni Nemocnice Plzen Plzen Czechia
ID Clinic Myslowice Poland
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Pratia S.A. Skorzewo Poland
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Kardiocentrum Nitra s.r.o. Nitra Slovakia
Krajska nemocnice Liberec a.s. Liberec Czechia
Ifslajtue Fob Cefxtkcp Ark Ehtcycnqzzre Mjplyjmg Prague Czechia
Equfltf Mechelen Belgium
Gh Mfy Kceh Ebpmplkqwhjwf Kiel Germany
Oxphfzlj nvdiflohe Mtskn Bejaijaf aguc npsikdgat Spzbhjjlcazmc kwwbu Mlada Boleslav Czechia
Lndg Mtenccf Cakr stjiua Bratislava Slovakia
Uawgwwjuel Oq Awfelho Edegem Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
15.02.2024
Czechia Czechia
Not recruiting
15.02.2024
Germany Germany
Not recruiting
15.02.2024
Italy Italy
Not recruiting
15.02.2024
Poland Poland
Not recruiting
15.02.2024
Slovakia Slovakia
Not recruiting
15.02.2024

Trial locations

Investigated drugs:

Zibotentan is a medication being studied for its potential to help manage fluid retention in patients with cirrhosis. It is being tested both on its own and in combination with another medication to see how it affects body weight, body water volumes, and body fat mass. The study also looks at how it influences the use of other diuretics and blood pressure.

Dapagliflozin is another medication involved in the study, used in combination with zibotentan. It is being evaluated for its effectiveness in managing fluid retention and its impact on body weight, body water volumes, and body fat mass in patients with cirrhosis. The combination is also assessed for its effects on the use of other diuretics and blood pressure.

Investigated diseases:

Cirrhosis of the liver – Cirrhosis of the liver is a condition in which the liver becomes scarred and damaged over time. This scarring is often the result of long-term liver damage from various causes, such as chronic alcohol use or viral hepatitis. As the liver tissue becomes increasingly scarred, it loses its ability to function properly. This can lead to complications like fluid retention, jaundice, and increased risk of infections. The progression of cirrhosis can vary, but it generally worsens over time if the underlying cause is not addressed. The liver’s ability to regenerate is impaired, making it difficult for the organ to recover fully.

Trial ID:
2023-506893-11-00
Protocol code:
ZEAL-UNLOCK
Trial Phase:
Therapeutic exploratory (Phase II)

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